Partnering for Care in HIV Prevention Trials: A How-To Manual

Transcription

1 Parterig for Care i HIV Prevetio Trials: A How-To Maual By Kathlee M. MacQuee ad Mike May Family Health Iteratioal

2 I July 2011, FHI became FHI 360. FHI 360 is a oprofit huma developmet orgaizatio dedicated to improvig lives i lastig ways by advacig itegrated, locally drive solutios. Our staff icludes experts i health, educatio, utritio, eviromet, ecoomic developmet, civil society, geder, youth, research ad techology creatig a uique mix of capabilities to address today s iterrelated developmet challeges. FHI 360 serves more tha 60 coutries, all 50 U.S. states ad all U.S. territories. Visit us at

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4 Parterig for Care i HIV Prevetio Trials: A How-To Maual By Kathlee M. MacQuee ad Mike May Family Health Iteratioal Natioal Istitute of Allergy ad Ifectious Diseases

5 Parterig for Care i HIV Prevetio Trials: A How-To Maual By Kathlee M. MacQuee ad Mike May 2008 by Family Health Iteratioal The Parterig for Care project was sposored by the Natioal Istitute of Allergy ad Ifectious Diseases (NIAID), Natioal Istitute of Child Health ad Huma Developmet, Natioal Istitute o Drug Abuse, Natioal Istitute of Metal Health ad Office of AIDS Research, Natioal Istitutes of Health, ad the U.S. Departmet of Health ad Huma Services (Cooperative Agreemet U01-AI to FHI). Fiacial support was also provided i part by the Uited States Agecy for Iteratioal Developmet (USAID) through Cooperative Agreemet No. GPO-A The cotet of this report does ot ecessarily reflect the views or policies of NIAID, HPTN, or USAID; or does metio of trade ames, commercial products, or orgaizatios imply edorsemet by the U.S. govermet. ISBN: Family Health Iteratioal P.O. Box Research Triagle Park, NC USA Telephoe: publicatios@fhi.org Web site: Photo Credits Cover: Kerry McLoughli, Patty Allema, ad Holly McClai Burke/FHI Chapter 1: Natasha Mack/FHI Chapter 2: Patty Allema/FHI Chapter 3: Beth Robiso/FHI Chapter 4: Holly McClai Burke/FHI Chapter 5: Kerry McLoughli/FHI

6 Table of Cotets Ackowledgmets About this Maual Executive Summary ii v vii Chapter 1: The Power i Parterig 1 Chapter 2: Methods Behid the How-To Steps 11 Chapter 3: Results from the Parterig for Care Project 15 Chapter 4: Seve Steps to Improvig HIV-Related Care 21 Chapter 5: Icorporatig Ethics 43 Appedix 1: Abbreviatios Used i this Maual 47 Appedix 2: Site Descriptios 49 Appedix 3: Refereces 53 Appedix 4: Checklist Local Obstacles ad Issues 55 Appedix 5: Checklist Public Health System Costraits 59 Appedix 6: Checklist Egagig the Commuity 63 Appedix 7: Checklist Care ad Treatmet Package 67 Appedix 8: Checklist Creatig a Referral System 69 Appedix 9: Checklist Resources to Implemet 71 page i

7 Ackowledgmets May orgaizatios ad idividuals provided fudig, time, ad iformatio i support of the Parterig for Care Project. The HIV Prevetio Trials Network (HPTN) ad Family Health Iteratioal (FHI) partered to direct this study. For their work i coductig case studies ad writig reports o this project, we thak FHI staff members: Patty Allema, Natasha Mack, Holly McClai Burke, ad Kerry McLoughli. We are particularly grateful to the followig HPTN staff ad the service orgaizatios, hospitals, ad cliics at case study sites: Durba, South Africa: The South Africa Medical Research Coucil, especially the staff of HPTN 035 RK Kha Hospital i particular, the VCT/ARV cliic, the primary health cliic, the gyecological departmet, ad public relatios The Family Health Towship Cetre Cliic i Chatsworth Chatsworth Child ad Family Welfare Chatsworth & Districts Partership Agaist AIDS (CADPPA) Harare, Zimbabwe: Uiversity of Zimbabwe Uiversity of Califoria, Sa Fracisco (UZ UCSF) Collaborative Research Programme Kampala, Ugada: Makerere Uiversity Johs Hopkis Uiversity (MU JHU) Research Collaboratio i particular, the psychosocial support group, MU JHU Peer Productios, the commuity advisory board, the World Food Programme voluteers, the cliical team members of HPTN studies, ad the health visitor teams Mulago Hospital i particular, the Istitute of Ifectious Diseases, the pediatric ifectious disease cliic, ad the ateatal cliic The AIDS Support Orgaizatio (TASO) ad the Mildmay Cetre page ii

8 Lilogwe, Malawi: Uiversity of North Carolia Project (UNC Project) ad executive members of the commuity advisory board Kamuzu Cetral Hospital i particular, Pediatrics, STI Cliic, Medical Ward, Lighthouse, ad Natioal Associatio of People Livig with HIV/AIDS (NAPHAM) Kaego AIDS Support Orgaizatio (KASO) Breast Milk ad Nutritio (BAN) Study Call to Actio Bottom Hospital Labor Ward Philadelphia, Pesylvaia, USA: The Uiversity of Pesylvaia HIV Prevetio Research Uit i particular, the staff of HPTN 037 ad the commuity advisory board Joatha Lax Ceter The Ifectious Disease Cliic at Presbyteria Hospital The Ifectious Disease Cliic at the Hospital at Uiversity of Pesylvaia Prevetio Poit Philadelphia Pue, Idia: Natioal AIDS Research Istitute (NARI) staff Staff ad study participats at the NIV NARI Cliic Members of NARI s commuity advisory board Talera, Sassoo, Jehagir, ad Sajeeva Hospitals Joh Paul Slum Developmet Project (JPSDP) Sehadeep Jaakalya Foudatio Deep Griha Society Prayas page iii

9 Rio de Jaeiro, Brazil: Fiocruz HPTN team members ad members of Frieds of IPEC support group Hospital dos Servidores do Estado HPTN team members ad members of Viva a Vida support group Nova Iguacu Hospital HPTN team members ABIA (Associação Brasileira Iterdiscipliar de AIDS) We would also like to ackowledge the isights ad support of the Parterig for Care Project Advisory Group: Quarraisha Abdool-Karim, Solomo Beatar, Gail Broder, Marge Chigwada (who also helped with writig reports), Sheila Jayaprakash, Stella Kirkedale, Neetha Morar, Steve Mori, Simagaliso Ntshele, Moica Ruiz, Seema Sahay, Kathy Shapiro, Cythia Woodsog, ad Dogbao Yu. Fially, we would like to thak the followig people who reviewed this maual ad the may helpful commets they provided: David Borasky, Paul Feldblum, Vera Halper, Alex Joh Lodo, Joseph Mfutso-Bego, Kathy Shapiro, Jeremy Sugarma, ad Steve Wakefield. I additio, we thak colleagues at the Global Campaig for Microbicides for sharig isights from their study, Mappig the Stadard of Care at Microbicide Cliical Trial Sites, which received fudig from USAID. We also appreciate the iformatio provided by members of the FHI research team, who shared isights from the oral teofovir pre-exposure prophylaxis trial i West Africa. May people also cotributed to the productio of this maual. I particular, we thak Jesse Hastigs for copyeditig ad Michael Szpir for maagig this project. This publicatio was desiged by Hopkis Desig Group. page iv

10 About this Maual This maual describes strategies for meetig the health care eeds of participats i cliical trials related to HIV/AIDS. The iformatio preseted here comes from the kowledge gaied from several studies: the Parterig for Care project, which was a collaboratio betwee the HIV Prevetio Trials Network (HPTN) ad Family Health Iteratioal (FHI), with fudig from the U.S. Natioal Istitutes of Health; HIV prevetio trials fuded by the U.S. Agecy for Iteratioal Developmet (USAID) ad implemeted by FHI ad others; ad a study carried out by the Global Campaig for Microbicides with USAID fudig, called Mappig the Stadard of Care at Microbicide Cliical Trial Sites. We created this maual to assist a wide rage of readers. These iclude cliical trial developers, implemeters, physicias, commuity parters, ad other stakeholders. Health care advocates of all kids could also beefit from some of the iformatio that follows. I additio, we hope that this maual proves useful to a rage of other readers, icludig public health experts, govermet leaders i trial commuities ad coutries, ad more. Overall, we hope that this maual serves as a resource to support health care efforts i may ways. Cosequetly, we iclude may aecdotes to give readers a sese of o-the-groud experieces that support our coclusios. Also, to give this maual a very practical side, we iclude a series of how-to steps ad checklists to simplify the applicatio of this iformatio. Although this maual focuses o health care related to HIV/AIDS cliical trials, much of the iformatio preseted here also applies to other situatios. For example, may of the steps explaied here could stregthe health care systems behid cliical trials for various coditios ad treatmets. Moreover, commuities or eve wider geographic regios could apply may of the steps described here to build a more effective system of health care i geeral. page v

11 If you have suggestios for improvig ay of the followig iformatio, we would welcome them. Please direct your commets to: Family Health Iteratioal P.O. Box Research Triagle Park, NC USA Telephoe: page vi

12 Executive Summary Esurig the effective care ad treatmet of people who are HIV positive is a critically importat couterpart to the search for methods to prevet the spread of the virus. May cliical trials of ew HIV-prevetio methods, such as vaccies ad microbicides, are uderway or plaed i several parts of the world. The me, wome, ad childre i these trials ofte face multiple health threats, ot simply from HIV, but also from poverty, huger, ad other challeges that ca drive poor health. Here, we describe a system for buildig bridges betwee the participats i these trials ad the health care they eed. The Parterig for Care Project udertake by the HIV Prevetio Trials Network (HPTN) ad Family Health Iteratioal (FHI), with fudig from the U.S. Natioal Istitutes of Health examied strategies at more tha two doze iteratioal cliical trial sites ad described the challeges faced ad successes achieved whe addressig the health care eeds of trial participats. Based o the results of the Parterig for Care project, we developed seve steps to buildig bridges betwee the research cotext ad local health care systems for participats i HIV cliical trials. (See box titled Seve Steps to Effective Parterig for Care. ) Several features i this series of steps ecourage iteractios betwee cliical trial developers, local commuities, host coutries, ad cliical trial participats, ad other groups. Also, this system of steps could be used by commuities ad orgaizatios to develop care for ay people livig with HIV/AIDS, as well as those with other health problems. page vii

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14 Seve Steps to Effective Parterig for Care Step 1: Build a public health attitude amog research leaders ad staff Viewig research as a compoet of public health ecourages research teams to fid problem-solvig opportuities. Step 2: Assess the local commuity s values, attitudes, ad priorities A successful health care strategy requires uderstadig of ad respect for local commuity perspectives. Step 3: Assess the assets ad costraits of the public health system The larger, surroudig system of public health must be assessed ad cosidered i developig a care strategy. Step 4: Egage the commuity The local commuity provides essetial support for a trial, such as practical guidace for recruitig participats ad for solvig health care challeges. Step 5: Determie the extet of care to provide Sposors ad pricipal ivestigators must determie what form of care will be provided, over what duratio, ad whether it will be provided by cliical trial staff or through parterships. Step 6: Build relatioships with earby resources Trial sites with earby resources ted to build bods that lead to better health care for the participats. Step 7: Develop a referral system These steps require a system that creates ad follows a referral from start to fiish, ad documets the process. page ix

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16 1 Chapter 1: The Power i Parterig

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18 Chapter 1: The Power i Parterig 1 There are may ways that HIV/AIDS touches ad coects all of us. Those ifected with HIV experiece direct cosequeces. Other people feel the impact through people they kow such as a family member, fried, eighbor, or coworker or i their work as health care providers, outreach workers, or couselors. Eve at a distace, we are coected through empathy geerated by the global reach of this devastatig pademic. Moreover, this virus proves difficult to overcome. It ca disguise or remodel itself, which presets researchers with a camouflaged or movig target. Though effective treatmets ow exist, it has bee challegig to develop them, ad a cure seems ulikely, at least for ow. Give the rapid spread ad complexity of HIV/AIDS, o perso, commuity, atio, or orgaizatio should stad aloe agaist this virus. To treat curret patiets ad reduce the extet of future ifectios, public health workers must build a variety of parterships aroud the globe. As of December 2007, accordig to the Uited Natios Joit Programme o HIV/AIDS (UNAIDS) ad the World Health Orgaizatio (WHO), HIV afflicted a estimated 33.2 millio people aroud the world, with some estimates reachig as high as 36.1 millio. Moreover, the level of HIV ifectio i 2007 marked a ew high. I that year aloe, 2.5 millio people acquired the virus ad aother 2.1 millio people roughly oe-third of a millio of them uder the age of 15 died from it. Chapter 1: The Power i Parterig page 1

19 Examiig the HIV/AIDS umbers o a daily basis emphasizes the acute public health emergecy created by this disease. Every day, over 6800 persos become ifected with HIV, ad over 5700 persos die from AIDS, mostly because of iadequate access to HIV prevetio ad treatmet services, reports the 2007 AIDS Epidemic Update. Although coutries ad commuities aroud the world all address HIV/AIDS, some areas are affected more tha others. I sub-sahara Africa, for example, AIDS is the leadig cause of death. The broad impact of HIV ad the difficulty i cotrollig or elimiatig it as a health threat stimulate a ogoig series of HIV prevetio ad treatmet cliical trials. Some of these trials test ew pharmaceuticals desiged to slow the progressio of disease i those who are ifected. Other trials study ways to prevet the trasmissio of HIV from a ifected mother to a child durig birth, or from oe sexual parter to aother. Some trials also test potetial vagial products to determie whether they ca protect wome from acquirig HIV durig sex; others test the use of atiretrovirals (ARV) by both me ad wome to prevet acquisitio. I fact, the list of itervetios beig tested covers a rage of approaches. The AIDS Vaccie Advocacy Coalitio (AVAC) keeps a updated list ad descriptio of HIV prevetio trials o their Web site ( The Trials ad Treatmets I additio to beig at risk for HIV, people erolled i these trials ofte face other health cocers. Some of the most commo health issues revolve aroud reproductio, icludig other sexually trasmitted ifectios ad uiteded pregacies. Likewise, trial participats ofte live with other diseases, icludig cervical cacer, malaria, ad tuberculosis. Other problems iclude social harms, such as domestic violece, family plaig challeges, ad substace abuse. I both developed ad developig coutries, participats i HIV prevetio trials ofte lack access to proper foods, resultig i huger ad malutritio. page 2 Parterig for Care i HIV Prevetio Trials

20 The breadth of these health issues geerates extesive medical ad psycho-social eeds amog the participats. Ufortuately, participats ofte face log lies ad waitig lists whe seekig care. Moreover, stock-outs of eve the most basic medicies are commo. 1 People livig with HIV/AIDS face eve greater challeges i securig atiretroviral therapy (ART) the oly treatmet that slows HIV. The day whe ART is available to ayoe who eeds it is a log way away, writes Hery Richardso i the America Joural of Public Health. Nevertheless, public health professioals cotiue to provide ART for a icreasig umber of people globally. Accordig to Ethical Cosideratios i Biomedical HIV Prevetio Trials, i low- ad middleicome atios, two millio people ifected with HIV had access to ART i 2007, ad that surpassed 2003 s availability of treatmet by five times. Noetheless, despite this tremedous progress i the roll-out of atiretroviral treatmet, global coverage of eeds is below 30%, cotiues this report. Curretly, people acquire HIV faster tha medical professioals ca secure ART for them. I 2006, for example, six more people acquired HIV for each ew perso placed o ART. Moreover, ART oly slows HIV; it caot cure it. Besides the fact that people must receive ART for life, atiretrovirals ca trigger side effects that rage from aemia to erve damage ad beyod, depedig o the specific drug ad perso. Noetheless, with appropriate medical care, people with HIV ca live log, productive lives thaks to ART. Effective HIV prevetio is eve more challegig tha treatmet. Nevertheless, atiretrovirals have bee prove effective for reducig the risk of trasmissio from ifected mothers to their ifats, ad male circumcisio has bee demostrated to provide a level of protectio agaist ifectio for heterosexual me. However, despite umerous trials of vaccies ad microbicides, oe has yet bee foud that is effective. For those curretly beig evaluated, it is also likely that ay that prove effective will, i fact, be oly partially effective. Cosequetly, biotechology ad pharmaceutical compaies, public health ad oprofit orgaizatios, ad govermets aroud the globe will cotiue to coduct cliical trials related to HIV prevetio for the foreseeable future. Chapter 1: The Power i Parterig page 3

21 The Parterig for Care Study As cliical trials cotiue, participats will also eed medical care. The iformatio i this maual was derived from cliical trial sites affiliated with the HIV Prevetio Trials Network (HPTN Established i 1999, HPTN brigs together more tha two doze iteratioal sites. Its curret research ageda focuses o ART for prevetio, behavioral itervetios, cotrol of sexually trasmitted ifectios (STIs), ad substace abuse. I the past, projects supported by HPTN also icluded microbicides ad periatal prevetio strategies. I 2004, HPTN idetified a eed to assess the care provided to trial participats at the participatig sites. Specifically, HPTN was iterested i studyig both HIV-related care ad the treatmet of other medical eeds. I additio, the etwork evisioed a study that would cosider both care provided directly by the cliical trial sites ad idirect care from referrals to other medical facilities. This overall visio emerged as the Parterig for Care project, with the goal of describig both the challeges faced ad successes achieved by HPTN research sites whe addressig the health care eeds of trial participats. The Parterig for Care project was udertake by HPTN i collaboratio with Family Health Iteratioal (FHI with fudig from the U.S. Natioal Istitutes of Health (NIH The iformatio i this maual also reflects experiece gaied from the coduct of HIV prevetio trials fuded by the U.S. Agecy for Iteratioal Developmet (USAID ad implemeted by FHI ad others. I additio, this maual beefits from a study, Mappig the Stadard of Care at Microbicide Cliical Trial Sites, carried out by the Global Campaig for Microbicides (GCM with USAID fudig. FHI grew out of cotraceptive research at the Uiversity of North Carolia at Chapel Hill i As a idepedet oprofit orgaizatio, FHI pursues a iteratioal public health missio: to improve lives worldwide through research, educatio, ad services i family health. Moreover, FHI forges a wide rage of parterships with commuity groups, govermetal ad ogovermetal orgaizatios, research istitutios, ad the private sector. page 4 Parterig for Care i HIV Prevetio Trials

22 Amog other goals, FHI helps to prevet the spread of HIV/AIDS. I 1987, FHI took charge of USAID s first five-year, HIV/AIDS prevetio program i developig coutries. Now, FHI has maaged more HIV/AIDS programs tha ay other group i the world. These programs operatig i more tha 60 coutries address a rage of objectives, icludig moitorig ad evaluatig programs, prevetig mother-to-child HIV trasmissio, ad promotig prevetio ad care. 1 For HIV/AIDS programs coected with HPTN ad FHI, USAID makes a strog parter. This federal govermet agecy created i 1961 supports a rage of policy objectives, icludig global health. From 1987 through Jauary 2006, USAID lauched HIV/AIDS prevetio programs i 32 coutries. Moreover, USAID has traied 40,000 people to support HIV/AIDS programs aroud the world. All three of these orgaizatios FHI, HPTN, ad USAID realize that cliical trial participats eed care that cotiues after the research stops. For example, Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials from UNAIDS/AVAC (AIDS Vaccie Advocacy Coalitio) otes,... trial participats have the right to access medical care for trial-related ijuries ad harm, ad to the experimetal product uder ivestigatio should it prove effective. I the specific cotext of biomedical HIV-prevetio trials, participats who acquire HIV ifectio durig the coduct of the trial have the right to access a comprehesive package of care, icludig evetual atiretroviral treatmet, which is egotiated before trial coduct ad defied i terms of compoets ad timeframe. As show i the results of the Parterig for Care project, servig the ogoig eeds of trial participats depeds o developig a pla for care that icludes specific features. For example, sustaiability ad cotiuity of care are best esured if participats ca be liked to appropriate health care i their local commuities. Moreover, successful likage requires establishig parterships with local cliics ad orgaizatios, verifyig that eeded care is available, ad esurig that those who are referred actually receive appropriate care. Chapter 1: The Power i Parterig page 5

23 Take Seve Steps This maual focuses o issues revealed i the Parterig for Care project. A effective health pla for participats i HIV/AIDS cliical trials depeds o buildig bridges betwee the research cotext ad local health care systems. To see how those goals ca be achieved, the Parterig for Care project studied systems at various sites from multiple cliical trials. Such breadth of kowledge provides readers with possible approaches for hadlig the variety of challeges that might arise uder differet circumstaces. For example, if a trial site lacks earby medical resources, what might ecourage or facilitate the trial staff to provide more care? Similarly, if leaders of a cliical trial develop parterships to refer participats to other facilities, how ca trial staff track the referrals? We address these questios ad others through a how-to approach. Usig the results from the Parterig for Care project ad related studies, this maual describes a seve-step approach to improvig the care for participats i eed durig HIV trials, ad for developig log-term solutios for post-trial care. (See box titled Seve Steps to Effective Parterig for Care. ) Each of the steps will be described i detail i later sectios. page 6 Parterig for Care i HIV Prevetio Trials

24 1 Seve Steps to Effective Parterig for Care Step 1: Build a public health attitude amog research leaders ad staff Whe the most difficult challeges arise for meetig participat health care eeds, success largely depeds o the attitude of the research team, especially those who provide leadership. Whe research is viewed as a compoet of public health, research teams see problem-solvig opportuities rather tha obstacles. Step 2: Assess the local commuity s values, attitudes, ad priorities The best itetios ca go astray if they are ot grouded i a uderstadig of ad respect for local commuity perspectives. Step 3: Assess the assets ad costraits of the public health system Ay health care related to a cliical trial operates withi a larger system of public health, icludig at the local, state, ad atioal govermet levels, ad that system must be assessed ad cosidered i developig care strategies. Step 4: Egage the commuity The effectiveess of ay cliical trial or system of health care depeds o gettig local commuities ivolved. This leads to may beefits, icludig support of a trial, helpig to recruit participats, more effective health care durig ad after the trial, ad a solid, log-term relatioship betwee the health care system ad commuities for ogoig programs of care ad future trials. Chapter 1: The Power i Parterig page 7

25 Step 5: Determie the extet of care to provide Early i the creatio of a system, sposors ad pricipal ivestigators must determie what care will be provided ad over what duratio. I additio, it should be determied what care will be direct provided by cliical trial staff ad what will be idirect provided through parterships with other medical facilities. Step 6: Build relatioships with earby resources The stregth of iteractio with local resources such as cliics, hospitals, ad pharmacies correlates with proximity. Trial sites with earby resources ted to build better bods that lead to better health care for the participats. Step 7: Develop a referral system Simply buildig parterships does ot esure effective idirect care. That requires a referral system a process that creates ad follows a referral from start to fiish, ad documets the process. page 8 Parterig for Care i HIV Prevetio Trials

26 We uderstad that some experts might recommed a differet order to these steps. Noetheless, we based this order o a particular ratioale. Specifically, Step 1 creates a midset that will be receptive to what is leared i Steps 2 ad 3. I combiatio, the first three steps provide a strog foudatio for egagig the commuity as a parter i the research edeavor, which is Step 4. With a public health attitude, kowledge about the local health system ad commuity, ad iformed iput from the commuity, the research team is well positioed to make determiatios about the extet of care to provide directly ad by referral, which is Step 5. I may situatios, however, the decisios made i Step 5 will be very tightly costraied by sposors, research etworks, research timelies, ad fudig. There eeds to be recogitio that such situatios icrease the potetial for problems dow the lie, as those costraits might work agaist the ability of the research team to develop a pla that meets local stadards for what is fair ad equitable. Steps 6 ad 7 logically follow from Step 5. 1 Eve Bigger Steps While these steps ca guide a process for developig better health care for participats durig ad after a cliical trial, this approach ca also yield other beefits. For example, this seve-step approach should foster a productive relatioship betwee cliical trial developers, local commuities, ad host coutries. The iteractive ature of these steps makes commuity leaders ad govermet officials iteract with cliical trial leaders as parters i the overall process. That partership ecourages future iteractios o additioal cliical trials. Moreover, the iteractio with commuities ad other orgaizatios ca also spark additioal programs, such as educatioal or public outreach programs, that ehace HIV/AIDS prevetio amog commuity members. This seve-step model also goes beyod health care i cliical trials. Commuities ad orgaizatios could follow these steps to develop care for ay people livig with HIV/AIDS, as well as those with other health problems, from medical care to psychological ad social assistace. Chapter 1: The Power i Parterig page 9

27 I the ed, a wide rage of parterships betwee researchers ad care providers ca support the public health effort agaist HIV/AIDS. The global impact of this disease ad the eed for complex forms of treatmet, as well as the value of behavioral steps to prevetio, demad that experts with may skills from aalytical ad cliical, to epidemiological ad psychological work together. The power of parterig makes up oe of the key itetios behid the iformatio provided here. page 10 Parterig for Care i HIV Prevetio Trials

28 Chapter 2: Methods Behid the How-To Steps 2

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30 Chapter 2: Methods Behid the How-To Steps 2 To develop a system of steps toward improved health care for participats i HIV/AIDS cliical trials, we worked from fidigs i the Parterig for Care project, as well as experiece gaied from HIV prevetio trials fuded by USAID ad the Bill & Melida Gates Foudatio ad carried out by FHI ad others. The complete results from the Parterig for Care project are available i Parterig for Care i the HIV Prevetio Trials Network. Part I: Overall Fidigs, by Kathlee M. MacQuee, Kerry McLoughli, Patty Allema, Holly McClai Burke, ad Natasha Mack, ad Parterig for Care i the HIV Prevetio Trials Network. Part II: Case Studies, edited by MacQuee ad McLoughli. Here, we provide a overview of the Parterig for Care project ad GCM s Mappig the Stadard of Care at Microbicide Cliical Trial Sites. I the summer of 2004, the Parterig for Care project started with a survey. Usig , MacQuee ad her colleagues cotacted the pricipal ivestigators ad study coordiators at all 33 of the HPTN sites. This survey simply asked yes or o if the sites had developed ay parterships to provide care for participats i cliical trials. I Jue 2005, the leaders of the Parterig for Care project set a secod survey. Oly those who had respoded to the first survey received the secod oe. I additio, the secod survey oly wet to staff at sites with a active or pedig HPTN protocol betwee May 2004 ad May For the secod survey, those who respoded o to the first survey were asked to describe health care referral optios, regulatory requiremets, ad ay other Chapter 2: Methods Behid the How-To Steps page 11

31 policies related to care for trial participats. Pricipal ivestigators ad study coordiators who respoded yes to the first survey also received a secod survey, which icluded the questios about health care referral optios, as well as a request to describe their parterships, amog other questios. By December 2005, the Parterig for Care project collected surveys from 16 sites. The, the study leaders cosulted with a project advisory group to select sites for case studies based o four criteria: Uique aspects regardig referral systems, referral follow-up, or capacity buildig Geographic diversity at least oe site from Africa, Asia, Lati America, ad the Uited States Adequate detail provided i the survey or from follow-up cotacts by ad telephoe Willigess o the part of the site research team to be a case study As a result of the two surveys, follow-ups, ad case-study criteria, the Parterig for Care project team selected seve HPTN sites for further study (see Appedix 2 for more details o each site): Fiocruz, Rio de Jaeiro, Brazil Makerere Uiversity Johs Hopkis Uiversity (MU JHU) Research House, Kampala, Ugada Medical Research Coucil (MRC), Durba, South Africa Natioal AIDS Research Istitute (NARI), Pue, Idia Uiversity of North Carolia Project (UNC Project), Tidziwe Cetre, Lilogwe, Malawi Uiversity of Pesylvaia, Philadelphia, Pesylvaia, USA Uiversity of Zimbabwe Uiversity of Califoria, Sa Fracisco (UZ UCSF) Collaborative Research Programme, Harare, Zimbabwe page 12 Parterig for Care i HIV Prevetio Trials

32 With the case study sites selected, project leaders tured to i-depth approaches. From March through May 2006, social sciece ivestigators from FHI workig with HPTN staff at the seve case study sites visited the cliical trial sites, referral treatmet sites, ad the commuities i which the trial participats lived or worked. These visits icluded observatios of the programs ad discussios with staff at the trial ad referral sites, as well as talkig with members of commuity advisory boards (CABs) where they existed. Each site visit lasted at least five days, ad follow-up cotacts through s ad telephoe calls provided additioal iformatio. 2 From the combied iformatio collected, the leaders of the Parterig for Care project assessed how sites develop ad maitai health care for cliical trial participats both through trial staff ad referrals to parters. I additio, the Parterig for Care project looked for the challeges faced i creatig ad maitaiig effective parterships. This maual also relies o fidigs from GCM s Mappig the Stadard of Care at Microbicide Cliical Trial Sites, which was coducted i mid This study examied the care ad prevetio services provided for wome primarily i cliical trials of microbicides used i HIV prevetio. Specifically, this GCM study evaluated six microbicide trials ad oe trial that studied the use of diaphragms for HIV prevetio. The GCM study icluded three phases. First, researchers studied documets related to the trials, icludig study protocols, stadard operatig procedures, policy documets, ad staff traiig mauals. Secod, the ivestigators coducted telephoe iterviews with study sposors ad staff, icludig at least oe pricipal ivestigator, from each site. Last, researchers visited six trial sites i four Africa coutries. The visits icluded iterviews with ivestigators ad staff, observatios of cliical facilities, ad assessmets of local ad referral care. We ca combie kowledge from this variety of studies icludig the Parterig for Care project, GCM s Mappig the Stadard of Care at Microbicide Cliical Trial Sites, ad others to assess a wide rage of health care strategies durig cliical trials desiged for treatmets that might prevet HIV. Chapter 2: Methods Behid the How-To Steps page 13

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36 Chapter 3: Results from the Parterig for Care Project 3 Health care for participats i HIV/AIDS cliical trials comes i two geeral forms: direct ad idirect. Direct health care comes from the cliical trial staff, ad idirect care comes through referrals based o parterships with other health facilities, such as cliics ad hospitals. The Parterig for Care project foud that most HPTN sites use a combiatio of direct ad idirect care. Specifically, 13 of the 16 sites that respoded to the FHI study use referral sites. Moreover, the HPTN sites arraged referrals with oe to seve sites most of them developed through parterships with other orgaizatios or facilities. I most cases, HPTN sites created referral systems to provide care that was ot available through the trial. Some referral sites also provided techical or laboratory support. I additio, some HPTN sites developed parterships for help with erollig participats i studies. The Parterig for Care project foud that the balace betwee direct ad idirect care depeds o several ofte iteractig factors: Public health system costraits. All HPTN sites work with participats with a rage of health care eeds. Moreover, the eediest participats were at sites where local health services struggled with log waitig lists ad limitatios i the level of care. Such costraits must be cosidered i developig a program of direct ad idirect care. Chapter 3: Results from the Parterig for Care Project page 15

37 Local commuity values, attitudes, ad priorities. The way people live their lives, iterpret their experieces, ad evisio their collective future eeds to be uderstood ad respected. Cultural, historical, ad political factors vary; a strategy that is successful i oe cotext might fail i aother. Public health attitude. Cliical trial leadership ad staff must recogize the balace betwee research ad health care challeges, meaig that trials must reach scietific goals while hadlig treatmet eeds. I may cases, the latter depeds o developig parterships for referrals. Referral follow-up. Oly by followig up o referrals ca cliical trial staff evaluate the performace ad limitatios of a referral system. Referral systems ca face a variety of challeges, icludig trasportatio eeds, costs of referrals to both the program ad the participats, pharmaceutical shortages, ad so o. Physical proximity. Referral systems prove more effective whe developed with earby resources. By developig parterships with earby facilities or by settig up research sites ear appropriate facilities, cliical trial staff ca keep better track of referral success or failure ad develop stroger parterships with the referral agecies. Capacity buildig. The availability of health care resources depeds o the research beig coducted by a cliical trial, the capabilities of the orgaizatio ruig the research, ad the resources available through the trial ad local facilities ad agecies. Buildig more capacity for health care depeds o assessig these resources for stregths ad weakesses. People livig with HIV/AIDS erolled i research. Studies focused o participats who are ifected with HIV ofte cotai more i-house health care resources for direct care. O the other had, studies that focus o healthy, uifected participats ofte must rely more heavily o referrals to parters. page 16 Parterig for Care i HIV Prevetio Trials

38 Commuity egagemet. To better uderstad the eeds of participats, cliical trial leaders ad staff ad the local commuity must iteract. Such iteractios improve problem-solvig ad ehace the health care provided to participats ad the commuity overall. Partership-buildig. May of the above factors deped o parterships, particularly for referral care. Such parterships develop through cotacts of the cliical trial staff, by iteractios with the commuity, ad sometimes through uique circumstaces that arise durig a study. 3 Although HIV/AIDS cliical trials face a rage of health care cocers ecoutered by participats, the eeds ofte surpass medical issues. For example, the Parterig for Care project also documeted a rage of psychological ad social challeges. May of the HPTN sites developed systems that specifically addressed such additioal eeds. For example, i Kampala, Ugada, the MU JHU team developed a Psychosocial Support Group that helps to meet a wide rage of eeds. (See box titled The MU JHU Psychosocial Support Group. ) Chapter 3: Results from the Parterig for Care Project page 17

39 The MU JHU Psychosocial Support Group Ages Ssedege ad other members of the MU JHU team created the Psychosocial Support Group i Ssedege was a health visitor part of a team of urses ad midwives that follows up o trial participats throughout a study. That support group started whe Ssedege arraged a meetig betwee HIV-positive participats i a trial ad a visitor to the research site. The ecouragig commets from the participats led Ssedege to see the eed for a support group, where participats could share cocers ad stories. The leaders of the MU JHU project agreed, ad the support group grew from five couples to 200 members i just oe year. Evetually, the MU JHU team made a official, full-time positio for Ssedege as psychosocial coordiator. Ssedege soo kow simply as Mama Ages was called oe of our agels by a member of the MU JHU team. Today, the Psychosocial Support Group provides may beefits beyod health care for trial participats. For example, oe program makes small loas available to members to start busiesses. Other programs provide grief couselig to families, skills for makig ad sellig crafts, peers who provide couselig, programs for HIV-positive childre, ad more. I fact, the Psychosocial Support Group proved so effective that members of the MU JHU team ofte voluteer their time to the group, icludig securig fudig from the Doris Duke Foudatio for a buildig for the group. page 18 Parterig for Care i HIV Prevetio Trials

40 To meet medical eeds ad psychological support at HPTN sites ad certaily withi ay group focused o care related to HIV/AIDS leaders must overcome oe ogoig problem: sustaiability. May health eeds, ad particularly those of people livig with HIV, exted well beyod the life of a cliical trial. To keep participats coected with the ecessary care ad treatmet, cliical trial programs must build parterships with health care i the local commuities. 3 Some cliical trials have already provided extesive health care for participats. The GCM s Mappig the Stadard of Care at Microbicide Cliical Trial Sites study, for istace, foud that the wome i those cliical trials ad eve those who screeed out received some effective HIV-prevetio services. They also received HIV testig, as well as pre- ad post-test couselig. Almost all wome screeed for trial participatio also received STI testig ad treatmet. To maitai a effective system of health care for participats i a HIV/AIDS cliical trial, leaders must focus o the list of iteractig factors: public health system costraits, public health attitude, stigma ad discrimiatio, referral follow-up, commuity egagemet, ad so o. Furthermore, these factors must be cosidered at stages from trial plaig through follow-up after a trial s completio. Chapter 3: Results from the Parterig for Care Project page 19

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42 Chapter 4: Seve Steps to Improvig HIV-Related Care 4

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44 Chapter 4: Seve Steps to Improvig HIV-Related Care 4 Early plaig forms the basis of ay effective health care system for participats i a HIV/AIDS cliical trial. For example, Ethical Cosideratios i Biomedical HIV Prevetio Trials from UNAIDS/WHO states, The provisio of atiretroviral treatmet to trial participats who acquire HIV ifectio durig the trial requires plaig for logistics ad implemetatio. I fact, plaig makes up the foudatio of all levels of health care offered to cliical trial participats. Noetheless, it is ot easy to meet those health care eeds without jeopardizig the coduct of trials or detractig from the goal of idetifyig critically eeded ew HIV-prevetio techologies. I a effort to help trial plaers maage these issues, we used results from the Parterig for Care project ad others to idetify seve steps to developig a system of care. As plaers review these steps, they will see a variety of obstacles that ca emerge. Developig a effective ad lastig system of care requires a assessmet of may factors, from medical ad scietific to cultural ad demographic. Ideed, by expectig challeges, plaers stad a much better chace of success. Oly the ca they create a health care program that meets as may eeds of the participats as possible. Our seve-step pla follows. Chapter 4: Seve Steps to Improvig HIV-Related Care page 21

45 Step 1: Build a public health attitude amog research leaders ad staff The success of a trial-related system of health care revolves aroud the attitudes of the people ruig the trial. Developig a public health attitude depeds o several factors: Recogizig that HIV-prevetio research is coducted i a larger cotext of health care delivery ad public health policy Kowig that the research team might eed to go beyod the miimum level of care ecessary to meet scietific goals Uderstadig the limits of what the research team ca accomplish i terms of providig health care while still meetig research goals Expectig to build parterships to exted care Embracig the value of empowerig commuity members to more effectively access health iformatio ad local resources for care Appreciatig that a key compoet to sustaiable improvemets i the health of host-commuity members is stregtheig the capacity of the local health system I combiatio, these factors ca fuel a better health care program, because they help the research team solve problems that may arise. Ofte, a ca-do attitude grows from a stated sese of moral resposibility for the well-beig of research participats that, i tur, creates a willigess to ivest persoally i buildig relatioships, idetifyig resources, ad creatig solutios. For istace, the research team at the MU JHU project i Kampala, Ugada, wrote grats that sought fudig to serve the eeds of their participats. The staff also cotributed persoal time ad moey ad arraged for commuity voluteers who helped study participats. Such altruism clearly goes beyod what is required of researchers. page 22 Parterig for Care i HIV Prevetio Trials

46 Step 2: Assess the local commuity s values, attitudes, ad priorities 4 Developig a trial-related system of health care must fit with local cultural orms. Accordig to Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials from UNAIDS/AVAC, Respect for commuities icludes respect for commual values; protectig ad empowerig social istitutios; ad, where applicable, abidig by the decisios of legitimate commual authority. Cosequetly, a health care program for participats i a cliical trial must cosider several factors: What are the key public health goals of the study populatio or local commuity? Is the local commuity ope to workig with outside groups? How does the local commuity view HIV/AIDS? For example, are ifected people shued? How does the local commuity view health care i geeral, ad is it ope to public health educatio? Are there ay forms of treatmet that go agaist local values? For example, is codom use stigmatized because it is associated with HIV or certai sexual behaviors? Is the local commuity ivolved i other issues such as ecoomic or political challeges that could affect health care? What belief systems are preset i the commuity, ad how do people view the relatioship betwee health ad faith, prayer, ad spirituality? These factors ca iteract i ways that beefit or block trial-related health care. For example, HIV hit Brazil i the early 1980s, whe the coutry also faced political urest battlig a dictatorship. Still, those people fightig the dictatorship teamed up with ogovermetal orgaizatios ad medical professioals to actively battle this disease. As a result, HIV-prevetio research i Rio de Jaeiro works alogside the commuities. As oted i Parterig for Chapter 4: Seve Steps to Improvig HIV-Related Care page 23

47 Care i the HIV Prevetio Trials Network. Part I: Overall Fidigs, Brazilia AIDS activist Herbert de Souza said, AIDS has to be viewed as a social issue ad ot a idividual problem. Plaers of health care i cliical trials for HIV/AIDS ca create eve more thorough ad effective programs by mirrorig that philosophy. To determie how local commuity values, attitudes, ad priorities might impact health care i a cliical trial, see Appedix 4: Checklist Local Obstacles ad Issues. Step 3: Assess assets ad costraits of the public-health system Ay trial-related system operates withi a larger system of public health, ad that must be assessed ad cosidered i developig a trial-related program of health care. I particular, cliical trial plaers must remember that a study takes place uder a rage of assets ad costraits: local commuity issues, as well as larger ecoomic, political, ad social situatios. This rage of assets ad costraits must be cosidered. For example, if a trial takes place i a area that ofte lacks crucial pharmaceuticals, simply referrig participats for care for commo ailmets such as malaria will be iadequate. Guidelies for assessig assets ad costraits are outlied i the box titled Assessig Assets ad Costraits from the Public Health System ; to apply these guidelies to the plaig of health care for participats i a cliical trial, see Appedix 5: Checklist Public Health System Costraits. page 24 Parterig for Care i HIV Prevetio Trials

48 4 Assessig Assets ad Costraits from the Public Health System The followig are guidelies that plaers ca use, adapted from the results of the Parterig for Care project: Cosider the commo medical eeds i the area, such as other ifectious diseases. How are these eeds likely to affect trial participats? How are they likely to affect trial implemetatio? Examie the available local care, such as cliics ad pharmaceutical availability ad cost. How ca these be used to provide health care to trial participats? Will the trial staff eed to provide additioal time ad materials to offset isufficiet local resources? Is the cost of key pharmaceuticals prohibitive for the public sector? Cosider the implicatios of marshalig local resources for participat care or of ijectig ew resources ito the host commuity. Will doig so create or exacerbate iequalities betwee trial participats ad oparticipats? Do the local services limit the types of care offered at specific locatios? Will this require trial participats to visit multiple locatios for health care? Cosider treatmets that are likely to be eeded by a participat s family members, icludig a spouse or childre. Which coditios will the trial address, ad how? How will providig these added treatmets affect the trial fiacially ad logistically? Chapter 4: Seve Steps to Improvig HIV-Related Care page 25

49 Cosider ecoomic costraits, such as lack of health isurace, eve i developed coutries. Will this prevet trial participats from receivig some forms of health care? Are free services available whe eeded? Study ay ogoig chages i govermet programs related to care that might affect participats. Could these chages affect the ways participats seek health care? Will these chages affect the local resources that provide health care? Note other fudig opportuities that could improve care. Could such opportuities reduce the fiacial resposibilities of the cliical trial? Could other fiacial resources improve the quality of health care for trial participats? Are there fuds that researchers ca access to improve care both withi the trial ad the larger commuity? page 26 Parterig for Care i HIV Prevetio Trials

50 Step 4: Egage the commuity 4 May of the steps listed here ivolve local commuities i some way. Cosequetly, effective health care related to a HIV/AIDS cliical trial must ivolve the local commuity (see Appedix 6: Checklist Egagig the Commuity). Egagig the commuity ca produce commuity support of the trial which, i tur, helps to provide participats with more effective health care both durig ad after the trial. As well, a solid, log-term relatioship with the commuity is importat for ogoig programs of care ad future trials. As Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials otes, Effective commuity egagemet durig the etire life-cycle of a biomedical HIV prevetio trial, ad beyod, through geuie, trasparet, meaigful participatory processes ehaces both the quality ad outcome of research. However, to make that egagemet as strog as possible, the plaers should ivolve commuities before the trial begis. Cliical trial plaers ad leaders ca egage commuities i a variety of ways: the followig poits are adapted from iformatio i Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials. Budget commuity ivolvemet ad educatio ito a trial s pla Begi ivolvig commuities early i the protocol developmet process Share goals of a study with commuities through writte plas or public meetigs Make someoe o the research team resposible for commuity iteractios Develop a CAB or other formal meas of collaboratio, with regularly scheduled meetigs ad a rage of members, such as: Govermet represetatives Commuity members of various ages ad sexes, particularly people who share the characteristics of the study populatio People livig with AIDS Chapter 4: Seve Steps to Improvig HIV-Related Care page 27

51 Local religious leaders Traditioal healers Members of the local media NGO/CBO represetatives Health officials Regularly review the researcher commuity relatioship through meetigs betwee trial leaders ad staff ad the commuities where the trial takes place I the Parterig for Care project, researchers documeted several examples of iteractios that improved relatios betwee commuity members ad cliical trial plaers ad staff. I Philadelphia, for istace, a CAB made educatioal videos about research o a HIV vaccie. Such iformatio, educatio, ad commuicatio strategies ca be developed to foster ot oly dissemiatio ad sesitizatio about research, but to esure that researchers are iformed about ad egaged with commuities i a substative way. For example, the NARI project i Pue, Idia, focuses cosiderable eergy ad resources o ivolvig the local commuity. There, the HPTN pricipal ivestigator ad commuity program supervisor give 30 percet of their time to activities related to commuity ivolvemet. Moreover, the cliical staff cotribute about 20 percet of their time to commuity activities. This project icludes 15 full-time staff members who ru a commuity outreach office that was desiged specifically to build ad urture the project s iteractio with the local commuity. As aother example, GCM s Mappig the Stadard of Care at Microbicide Cliical Trial Sites foud that STI care could improve through more work with local commuities. The trials described i the GCM mappig study took place i areas with relatively high rates of STIs ad limited public-sector services to diagose ad treat them, especially i wome. Cosequetly, most of the trials provided STI testig ad treatmet for all wome screeed for trial participatio, as well as treatmet or referral for their sexual parters, as a service to the page 28 Parterig for Care i HIV Prevetio Trials

52 commuity. Sice STIs were secodary edpoits for all but oe of the trials described, regular STI testig ad treatmet was doe primarily for research purposes, but the decisio to test ad treat wome at a first screeig visit gave them free STI care, eve whe they proved ieligible to participate i the trial. The Mappig study cocluded that trial staff could cotribute i a sustaiable way by traiig local providers i sydromic maagemet of STIs ad ecouragig use of effective, sigle-dose treatmets. 4 Chapter 4: Seve Steps to Improvig HIV-Related Care page 29

53 Step 5: Determie the extet of care to provide, ad the balace betwee direct versus idirect care I Ethical Cosideratios i Biomedical HIV Prevetio Trials, UNAIDS/WHO otes that a health care package for participats i HIV/AIDS cliical trials ca ivolve may features: Couselig Prevetive methods Treatmet for other sexually trasmitted ifectios Prevetio of mother-to-child trasmissio Prevetio ad treatmet of tuberculosis Prevetio ad treatmet of opportuistic ifectios Nutritio Palliative care, icludig pai cotrol ad spiritual care Referral to social ad commuity support Family plaig Reproductive health care for pregacy ad childbirth Home-based care ART Legal assistace Services for orphas ad vulerable childre (OVC) A cliical trial team might ot be able to provide this etire list. I fact, there is o cosesus o the precise list of care that should be provided. For example, Hery Richardso writes i the America Joural of Public Health that whe dealig with ifected patiets i a developig coutry, the researchers might provide ay of the followig levels of care: 1) recommed treatmet ad provide a referral; 2) provide oly palliative care for opportuistic ifectios; page 30 Parterig for Care i HIV Prevetio Trials

54 3) provide palliative care ad try to arrage fuds to pay for ART; 4) provide palliative care ad provide or pay for ART; or 5) provide palliative care, ART, ad moitorig. But for how log should researchers provide care? Plaers of a cliical trial should decide ahead of time what services to provide for participats ad for what period of time, such as to the ed of the trial or loger. The potetial for the emergece of drug-resistat HIV strais whe ART is stopped with implicatios for both idividual ad commuity well-beig uderscores the importace of thikig about the log term. 4 To a extet, the offered treatmet depeds o the skills ad resources of the cliical trial staff. So, durig plaig, the i-house capabilities must be cosidered to assess the potetial for direct care. Each site must decide how far dow the list of health care eeds the research team ca go without depletig the time, resources, ad eergy eeded to do the research (see Appedix 7: Checklist Care ad Treatmet Package). I some cases, the ature of a trial will ot iclude staff who ca offer basic health care to participats. For example, at the HIV Prevetio Research Uit at the Uiversity of Pesylvaia Ceter for Addictio Studies, the staff rus behavioral studies. Cosequetly, most health issues amog trial participats get resolved through idirect care, or referrals. Because referrals are so importat, cosiderable effort has goe ito developig a comprehesive list of agecies ad orgaizatios that provide eeded services. Persoal cotact betwee ceter staff ad key service providers is also emphasized. Direct ad idirect care offer both pros ad cos. Direct care, for example, provides may beefits: Participats ca get health care without goig to cliics with log wait times; it ca reduce strai o local health care facilities; ad it ca build goodwill betwee leaders of a cliical trial ad the local commuity. O the other had, direct care also creates some trouble spots, such as takig away time ad resources from the trial itself, as already metioed. Moreover, there is also a risk that research sites that provide substatial health care directly to participats will draw staff away from already stressed health care facilities, thus iadvertetly udermiig local capacity. Fially, depedig o the degree of direct care provided, it might create Chapter 4: Seve Steps to Improvig HIV-Related Care page 31

55 perceptios of udue iducemet for people to joi a trial. As a result, it becomes especially importat to clarify the differece betwee stadard of care ad the research itervetio durig the coset process, as therapeutic miscoceptio is commo i may resource-limited settigs. With idirect care, obstacles might be more apparet, such as requirig participats to arrage care at other facilities, fid trasportatio, ad so o. Noetheless, idirect care ca also provide advatages, such as buildig relatioships betwee cliical trial teams ad local professioals ad leaders. This type of care ca also ehace sustaiability of care for participats after the research has eded. Differet cliical trials might also ecourage differet forms of care. For example, GCM s report o Mappig the Stadard of Care at Microbicide Cliical Trial Sites ecourages cervical screeig, i part because HIV-positive wome ru a higher risk of cervical cacer. There is also icreasig support for providig wome i microbicide trials with cotraceptio to improve overall care, as well as to ehace research desigs. Ivestigators i the GCM study also foud that direct provisio of cotraceptio icreased the time that participats spet o the study product. This icreased the power of the study to show a differece betwee separate arms of the trial, because pregat wome could ot use the product. I some cases, trial leaders must cosider health care for people who fail to qualify for a trial. For example, at the UZ UCSF project i Harare, Zimbabwe, a cliical trial could ot eroll HIV-positive people. Noetheless, the local CAB wated the trial leaders to provide care for people idetified as HIV-positive durig the screeig process. As a result, the trial leaders developed a system of care for those people, which icluded both direct ad idirect features. Those who screeed ieligible for the study because they are HIV-ifected received two additioal couselig sessios at the research site ad referral to services as eeded, icludig geeral, opportuistic-ifectio, ad socialwelfare referrals. The parters of the potetial participats who screeed ieligible are also offered HIV testig. page 32 Parterig for Care i HIV Prevetio Trials

56 Step 6: Build relatioships with earby resources 4 The stregth of iteractio with local resources cliics, hospitals, pharmacies, ad so o correlates with proximity. Trial sites with earby resources ted to build better bods that lead to better health care for the participats. For example, the Fiocruz site i Rio de Jaeiro works with three govermet health care sites: two i the city ad oe i a very poor sectio outside the city. These three cliic locatios provide patiets with immediate access to some of the highest quality care i Rio. This collectio of sites also gives participats a choice o where to seek health care. Workig with earby parters provides several health care beefits: Improved ability to hadle referral challeges Participats have easier access to further care, perhaps eve withi walkig distace or ear where they live or work Easier follow-up o referrals for example, through meetigs with referral staff Workig with earby parters, though, ca also create challeges: The proximity ca make research staff feel compelled to escort participats to referral sites, which takes time ad might violate a participat s privacy ad cofidetiality. Research staff ca also be expected to provide more resources or staff time to referral sites tha is possible. I balace, however, earby parters provide log-term beefits. For example, these relatioships cotribute to capacity buildig. I the comig years, there will be icreasig demads o cliical sites so that atioal govermets, sposors, ad researchers should thik about how to sustai site capacity ad retai research staff expertise, accordig to Ethical Cosideratios i Biomedical HIV Prevetio Trials. Give the log time frames of biomedical HIV prevetio Chapter 4: Seve Steps to Improvig HIV-Related Care page 33

57 research, special attetio to commuicatio ad trasparecy is eeded i order to build ad maitai trust with participatig commuities, ad to sustai site capacity eve after the ed of a trial. Nearby parterships ca trigger such beefits, especially sustaiability. Likewise, GCM s Mappig the Stadard of Care at Microbicide Cliical Trial Sites examied how care cotiued after the study. It also foud that study sites that set up stad-aloe cliical facilities to provide care caot cotiue it whe the study is over. Eve if those sites were utilized for ew research, they oly provide care related to screeig or participatio for that trial. However, sites that provided care for participats through parterig ad capacity buildig of established public health facilities ad were co-located with them (e.g., withi or ext door) eabled screeed-out wome, families, etc., to cotiue to access the same level of care as those participatig i the trial. Oe site set up a parallel, mobile system of care for participats, but it is questioable whether this system will be sustaiable whe the trial is over. I buildig parterships, cliical trial plaers ad leaders must kow what they ca provide. This ca iclude: Fudig Ifrastructure, such as cliic repairs or providig laboratory equipmet Staff time icludig medical screeig doe as part of the research protocol, which reduces strai o earby staff Supplies Traiig For example, the UNC project i Malawi madates that all medical staff cotribute oe day a week i local cliics ad hospitals. I additio, this project provided laboratory use, medical ad office supplies, pharmaceuticals, ad other resources for the Kamuzu Cetral Hospital. page 34 Parterig for Care i HIV Prevetio Trials

58 O the other had, cliical trial plaers ad leaders must kow what they expect from parters. This ca iclude: 4 Additioal medical treatmet Further testig Psychological or social beefits for participats The parterships ca also go beyod medical facilities. Local orgaizatios ca help with commuity iteractios. For example, at the UNC Project i Malawi, the commuity-based group, Natioal Associatio of People Livig with HIV/ AIDS i Malawi (NAPHAM), refers participats to the cliical trials. This group is active i the CAB ad coducts educatioal dramas about specific research studies i marketplaces, i collaboratio with commuity educatio staff. Such coectios provide eve broader capacity buildig. To build such parterships, cliical trial leaders ca use several approaches: Make cotacts through acquaitaces i the local commuity Coect with commuity members, perhaps through hirig a commuity liaiso officer who ca build strog local cotacts ad has effective etworkig skills, ad who ca visit referral sites o a regular basis Develop a formal parterig process, such as sedig a member of the cliical trial staff to make a presetatio to a potetial parter idetified by the commuity liaiso officer Put agreemets i writig, such as a Memoradum of Uderstadig or other locally relevat documets that outlie what each will cotribute to the partership ad how research participats will beefit The sites studied by the Parterig for Care project used various partershipbuildig techiques. Projects i Durba ad Hlabisa, for istace, used the commuity liaiso officer approach. I Pue, a commuity programs supervisor works with the cliical trial s pricipal ivestigator to build ad sustai parterships. The key, really, comes from developig a partershipbuildig pla ad cotiuig to work at it. Chapter 4: Seve Steps to Improvig HIV-Related Care page 35

59 Step 7: Develop a referral system May of the steps above metio idirect care through referrals, ofte with parters. Noetheless, simply buildig parterships does ot esure effective idirect care (see box titled Trials with Teofovir ). Gettig the most effective idirect care requires a referral system a process that creates ad follows a referral from start to fiish, ad documets the process (see Appedix 8: Checklist Creatig a Referral System). Such a system works best if it icludes several features: A formal referral procedure, such as providig a participat with paperwork that outlies the itetio of the referral Mechaisms that get participats to the referral site A follow-up procedure At the UNC project i Malawi, staff members foud that participats or their family ofte failed to obtai idirect care simply because they did ot go to the referral site. The reasos for ot goig were ofte related to lack of trasportatio. Sometimes they also resulted from a decisio to go home first, especially if the participat was cocered about a log wait at the referral cliic, with the result that efforts made to facilitate the referral were udoe. To bypass that problem, a urse o the cliical trial staff was available to escort the participat to the referral site, providig trasportatio if eeded, ad thus esurig that the participat could receive eeded care i a expedited way. Thus, this solutio addressed the realities of the local health care system, as well as participat cocers about time away from family ad household resposibilities. However, to track the effectiveess of a referral, cliical trial staff must follow up o it. All 13 sites studied i the Parterig for Care project used some type of follow-up procedure. For istace, may sites performed this follow-up through discussios with the participat o the ext visit i the cliical trial. Likewise, if a study placed staff members at a referral site for some exchage of page 36 Parterig for Care i HIV Prevetio Trials

60 services, this also allowed referral follow-up. Eve if a participat screeed out of a trial, some studies tried to follow up o ay related referrals, either by cotactig the screeed-out participat or the referral site to see if participats were accessig care. However, i may places, referral sites may ot provide ay iformatio o their cliets so as ot to violate their privacy ad cofidetiality. Follow-up of screeed-out participats ca also require cosiderable staff time, especially i areas where 25 percet (or more) of participats might be screeed ieligible due to HIV ifectio or other health reasos. 4 Referral follow-up also exposes potetial problems: Costs to participats at the referral site Drug stock-outs at the referral site Icomplete referral treatmet Log waits for care at referral sites Trasportatio issues Uderstaffig at the referral site However, by discoverig such obstacles to referral treatmet, the cliical trial staff could implemet solutios, such as: Provide fudig to participats to cover referral costs. Typically, coverig these costs has a miimal impact o site resources, but it removes a major obstacle for participats. Coverig such costs ca also be accomplished via a fiacial cotract betwee the trial ad a local provider or orgaizatio if direct reimbursemet to participats is problematic. Stock eeded pharmaceuticals at the study or referral site Provide medical documetatio to reduce strai o the referral-site staff, improve participat treatmet, ad reduce wait times Provide trasportatio to the referral site If a referral site is uderstaffed, the cliical trial team might be able to provide some staff hours Chapter 4: Seve Steps to Improvig HIV-Related Care page 37

61 Two sites employed referral slips as part of a follow-up system. A participat received a slip that documeted the eeded treatmet, ad the the trial staff could see if the slips eded up at the referral site, idicatig that the participat completed the referral. Although this seems like a good system, it provided mixed results at best. I some cases, a referral slip helped trial participats move ahead i treatmet lies, which was helpful. However, i terms of trackig the success of referrals, the slips occasioally got lost at the referral site. This highlights oe of the issues for follow-up of referrals: They should ot add a additioal admiistrative burde to a already over-burdeed referral site. I the ed, a referral follow-up system depeds o eergy from the trial staff. Someoe from the trial staff must make regular visits to the referral site to observe the complete process. Oly the ca follow-up problems be idetified ad repaired. For a overview of the resources that ca be used with these seve steps, see Appedix 9: Checklist Resources to Implemet. This checklist provides suggestios of approaches ad likely timeframes. Through these seve steps, cliical trial plaers, leaders, ad staff ca develop a effective health care system for participats i a HIV/AIDS study. The esuig results will beefit the participats ad create lastig relatioships betwee trial staff, commuity leaders, ad parters. page 38 Parterig for Care i HIV Prevetio Trials

62 Trials with Teofovir 4 Betwee Jue 2004 ad March 2006, FHI staff ad others ra a Phase II cliical trial to determie whether teofovir a atiretroviral drug that has bee used to treat HIV ifectio could be used to prevet ifectio as well. The FHI trial was coducted i Cameroo, Ghaa, ad Nigeria, with fudig from the Bill & Melida Gates Foudatio. As published i PloS Cliical Trials, too few HIV ifectios occurred durig the trial to idicate whether teofovir is protective, but this trial did show that short-term use of teofovir is safe ad acceptable for HIV-egative wome at high risk of becomig ifected. However, beyod the cliical results, this trial revealed some of the challeges i developig a effective referral system. Before the trial started, FHI collaborated with host-coutry social scietists to coduct formative research at all sites. This research icluded assessmets of the care ad treatmet available at each site for people livig with HIV ad AIDS. The cliical research teams at each site used this iformatio to develop referral procedures for participats who tested HIV positive durig screeig, or durig the trial itself. Here, we will focus o Cameroo, where the trial erolled 400 wome. The Cameroo formative research team visited facilities ad orgaizatios that could potetially provide health care ad services for the trial participats. I additio, researchers iterviewed people livig with HIV/AIDS ad health care experts treatig them to lear more about the resources available. Based o this iformatio, the formative research team prepared a report, which was shared with the cliical research team. The latter the developed a referral system for wome idetified as seropositive. As plaed, this system Chapter 4: Seve Steps to Improvig HIV-Related Care page 39

63 would deped o a cliic that was implemetig a ew program for ART. Moreover, this cliic s chief medical officer was the mai physicia for the trial i Cameroo. To facilitate referrals for all health care eeds of trial participats, FHI added fiacial support for each trial site to hire a health couselor or referral maager. This positio was desiged to help trial participats obtai referral care, icludig wome who tested HIV positive at screeig ad those who became HIV positive durig this trial. The health couselor would also hadle other obligatios, icludig accompayig ay seropositive woma to the referral service to help her register, developig relatios with referral care providers, maitaiig a database of referral optios, ad other admiistrative duties. Despite these efforts, FHI staff foud that Cameroo s referral system was havig problems. About the same time, Act Up-Paris raised cocers about the ability of serocoverters to access HIV care ad treatmet, icludig ART. Ultimately, the difficulties with the referrals seemed to stem from poor commuicatio ad lack of a explicit agreemet with the ART program at the local cliic prior to the begiig of the trial ad referral of participats for care. As cotroversies about the trial mouted, tesios also icreased with regard to referrals from the trial to the ART program. I February 2005, Cameroo s Miistry of Public Health suspeded this trial s ability to provide the study product (teofovir or placebo) to participats. The Miistry s subsequet review of study procedures resulted i a umber of recommedatios, all of which were addressed. However, permissio to restart the trial was ever give, ad FHI closed the Cameroo trial i September page 40 Parterig for Care

64 4 Still, a meetig of various stakeholders spawed a pla for log-term care ad treatmet for the 10 wome i Cameroo who serocoverted durig the trial. This icluded fudig for 10 years of pre-art care ad five years of ART care. The Miistry decided that a govermet hospital should provide this care ad treatmet. Cosequetly, FHI egotiated the 15-year cotracts ad deposited fuds (provided by the Gates Foudatio) to provide care for the wome who became ifected while erolled i the teofovir study i Douala, Cameroo. Despite these efforts, it cotiues to prove extremely difficult to lik the 10 wome from the trial with the care ad services that had bee egotiated o their behalf. FHI staff have commuicated repeatedly with cotacts at the govermet hospital, but have ot yet received ay respose. Efforts to work with a local commuity orgaizatio to facilitate the relatioship betwee the serocovertig wome ad the hospital were iitially successful, but the fell apart whe a key perso left the orgaizatio. Based o this experiece ad other work, FHI ow requires that referral procedures for serocoverters be formalized ad stadardized for the HIV prevetio trials that it implemets. Cosideratios whe establishig such procedures should iclude: formal agreemets with referral sites, desigated fudig to support the referrals, staff that maage referrals, ad documetatio that esures that the procedures create the iteded outcomes. Chapter 4: Seve Steps to Improvig HIV-Related Care page 41

65 page 42 Parterig for Care i HIV Prevetio Trials

66 Chapter 5: Icorporatig Ethics 5

67 page 44 Parterig for Care i HIV Prevetio Trials

68 Chapter 5: Icorporatig Ethics 5 I orgaizig the health care treatmet of participats i cliical trials aimed at prevetig HIV/AIDS, trial plaers ad staff must cosider various ethical obligatios. The precedig chapters touch o some of these obligatios, particularly through examples, such as keepig i mid costraits created by cultural orms. Of particular ote, the practices described here are closely aliged with priciples of justice ad fairess. They both seek to meet the eeds of the participats ad to miimize creatig ew disparities i health care access based o research participatio. Wherever possible, they attempt to raise stadards for the commuity as a whole. This chapter outlies further ethical issues ad how to assess them. Much of the ethical challege lies aroud acillary care, or care that is provided eve whe it is ot part of the study. As oted by participats i the 2006 Georgetow Uiversity Workshop o the Acillary-Care Obligatios of Medical Researchers Workig i Developig Coutries, [w]hichever argumets supportig researchers acillary-care obligatios are accepted, it is clear that these obligatios exted to diseases ad coditios urelated to what is uder study. The implicatios of justice are ot restricted to the target disease aloe; either are the implicatios of due cocer for welfare, rescue, or what is effectively etrusted to researchers by cosetig to participate i certai procedures. The participats outlied four guidace poits ( The Four Ps ) that should be cosidered i ethical discussios of acillary care obligatios: positive duty, plaig, partership, ad practical provisio. (See box titled The Four Ps. ) Chapter 5: Icorporatig Ethics page 43

69 The Four Ps: Guidace Poits o Acillary Care Obligatios The participats i the 2006 Georgetow Uiversity Workshop o the Acillary-Care Obligatios of Medical Researchers Workig i Developig Coutries idetified the followig poits as basic to ethical guidace o acillary-care obligatios. Positive duty: Researchers ad research sposors, especially those workig i developig coutries, have some positive moral obligatio to provide some acillary care to their study participats (or to see to it that their participats receive such care). Plaig: Researchers ad research sposors, especially those workig i developig coutries, should develop plas, both i geeral ad for each protocol, for meetig the acillary care obligatios that may be expected to arise. They should also take accout of the upredictable ature of acillary care eeds ad pla accordigly. Partership: These acillary care plas should be developed i dialogue ad partership with the host commuity, i ways that maitai respectful iteractio; avoid displacig or disruptig local health care structures; ad represet the populatio of potetial study participats, commuity advisory boards, ad the local medical commuity. Practical provisios: Where they have foreseeable acillary care obligatios, researchers ad research sposors should take defiite practical steps toward meetig these obligatios. This might mea hirig a physicia with certai competecies as part of the local study team, settig aside a certai lie item or percetage of the budget, or formig parterships with those who ca provide drugs or with developmet agecies that ca aid i improvig the local ifrastructure. page 44 Parterig for Care i HIV Prevetio Trials

70 Ufortuately, the qualitative ature of these factors meas that o simple formula aswers the questio: Should the trial staff provide a specific form of acillary care i a particular circumstace? Like may of the topics discussed i this chapter, trial leadership must weigh various factors sometimes, o a case-by-case basis to determie whe acillary care will or will ot be provided. The qualitative ature of the decisio also uderscores the importace of commuity egagemet ad participatio, as described i the UNAIDS/AVAC documet o Good Participatory Practices i Biomedical HIV Prevetio Trials. 5 The health care package for trial participats should also iclude discussios of potetial beefits ad risks. Every cliical trial carries some medical risk, ad a HIV prevetio trial ca geerate additioal risks, icludig: Axiety Depressio Potetial public discrimiatio or stigma Stress o the participat ad possibly the family Where possible, couselig ad care should be available for participats who experiece side effects. I additio, cliical trial staff should cousel participats o methods of reducig risk durig ad after the trial. Give some of the potetial risks particularly public discrimiatio or stigma participats should also be assured that all iformatio ad data will remai cofidetial. For example, i Guidelies o Protectig the Cofidetiality ad Security of HIV Iformatio: Proceedigs from a Workshop, UNAIDS writes, Cofidetiality relates to the right of idividuals to protectio of their data durig storage, trasfer, ad use, i order to prevet uauthorized disclosure of that iformatio to third parties. Ay trial pla should iclude a writte cofidetiality policy that describes how iformatio ad data will be collected, stored, trasferred, ad released. Typically, a cofidetiality ad security officer oversees such tasks, but the etire trial staff must also be aware of the procedures ad kow how to implemet them. Otherwise, the collectio of Chapter 5: Icorporatig Ethics page 45

71 iformatio o testig ad treatmet caot be kept secure, which could cause damage i the lives of participats. Cofidetiality eeds to be explicitly cosidered whe developig a referral pla, especially for HIV-positive research participats. I fact, participat cocers about cofidetiality ca be a sigificat barrier to effective referrals for those ewly discovered to be ifected. Additioal challeges emerge whe prevetio trials are implemeted across multiple sites i multiple coutries. The UNAIDS/AVAC documet, Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials, otes that local miistries of health, ethics committees, ad regulatory bodies might have diverget requiremets. Trial sposors, i tur, might try to establish uiform stadards for participatig research sites. At oe site, for istace, the sposor s requiremets might provide a miimal baselie, while at aother site, the sposor requiremets might fall below the baselie required by local research goverace. Negotiatig such differeces ad arrivig at solutios that are feasible ad equitable will likely remai a challege for some time to come. The Seve Steps outlie a strategy for avigatig these ethical challeges. page 46 Parterig for Care i HIV Prevetio Trials

72 Appedices Appedices page 47

73 page 48 Parterig for Care i HIV Prevetio Trials

74 Appedix 1: Abbreviatios Used i this Maual 1 AIDS: acquired immuodeficiecy sydrome ART: atiretroviral therapy ARV: atiretroviral AVAC: AIDS Vaccie Advocacy Coalitio CAB: commuity advisory board GCM: Global Campaig for Microbicides FHI: Family Health Iteratioal HIV: huma immuodeficiecy virus HIVNET: HIV Network for Prevetio Trials HPTN: HIV Prevetio Trials Network HVTN: HIV Vaccie Trials Network MRC: Medical Research Coucil, Durba, South Africa MTCT: mother-to-child trasmissio MU JHU: Makerere Uiversity Johs Hopkis Uiversity NARI: Natioal AIDS Research Istitute, Pue, Idia Appedices page 47

75 NIH: U.S. Natioal Istitutes of Health PEPFAR: U.S. Presidet s Emergecy Pla for AIDS Relief STI: sexually trasmitted ifectio UNAIDS: Joit Uited Natios Programme o HIV/AIDS UNC: Uiversity of North Carolia USAID: U.S. Agecy for Iteratioal Developmet UZ-UCSF: Uiversity of Zimbabwe Uiversity of Califoria, Sa Fracisco WHO: World Health Orgaizatio page 48 Parterig for Care i HIV Prevetio Trials

76 Appedix 2: Site Descriptios 2 This appedix provides a overview of each of the seve sites participatig i the case studies for the Parterig for Care project. For more details, see Parterig for Care i the HIV Prevetio Trials Network. Part II: Case Studies. Fiocruz, Rio de Jaeiro, Brazil The Brazilia govermet plays a fudametal role i health care through its uiversal health system. This icludes treatig HIV/AIDS i Rio de Jaeiro. For example, i 2006, more tha 80 percet of Brazilias who eeded ART received it, accordig to UNAIDS. I additio, the govermet provides ART for free. The Brazilia govermet also sposors Rio s HPTN cliical trial site. It participated i two HPTN trials that studied serodiscordat couples, as well as may cliical studies directed by other orgaizatios. This site cosists of a o-site cliic at Fiocruz, called the Evadro Chagas Cliical Research Istitute, ad two off-site locatios at hospitals: Nova Iguacu Geeral Hospital (Nova Iguacu) ad Servidores do Estado Hospital (Servidores). Fiocruz ad Servidores lie iside Rio, ad Nova Iguacu lies about a hour (by bus) outside the city. Nova Iguacu icludes extremely poor areas, ad this hospital s emergecy room receives a average of 1,500 visits per day. The Evadro Chagas Cliical Research Istitute i Fiocruz maages this threelocatio site. All data ad laboratory maagemet come from Fiocruz. Appedices page 49

77 Makerere Uiversity Johs Hopkis Uiversity (MU JHU) Research House, Kampala, Ugada Kampala is Ugada s capital ad is home to more tha oe millio people. I 2005, accordig to UNAIDS, HIV ifected early 7 percet of the adults i the coutry. Of those who eeded ART, about 50 percet received it. ART is freely available from several sources, icludig govermet hospitals ad various treatmet ceters with public ad private support. This HPTN site has bee active for 20 years. This uiversity-based site has participated i various cliical trials, icludig those for prevetig mother-to-child trasmissio of HIV, tests of a HIV vaccie, ad other research. It provides services from the study s cliic ad Mulago Hospital, which is at the same locatio as the HPTN site. The staff at this site speds about 30 percet of its time providig care. This HPTN site has also participated i various treatmet programs, icludig the MTCT Plus Program, which is fuded by Columbia Uiversity. MTCT Plus provides care, treatmet, ad ARVs for families with a HIV-positive member. Medical Research Coucil (MRC), Durba, South Africa Durba is the secod-largest city i South Africa ad home to more tha three millio people. I 2005, early 20 percet of the people ages were ifected with HIV. Although govermet hospitals ad the U.S. Presidet s Emergecy Pla for AIDS Relief (PEPFAR) provide ART for free i South Africa, fewer tha 20 percet of the people who eed ART get it. I part, that low treatmet rate could come from the small fee required to access the care at govermet hospitals ad local cliics. The MRC site i Durba started i This govermet-sposored site focuses o research ad has ru various cliical trials, icludig studies of HIV prevetio i wome ad serodiscordat couples. These studies icluded tests of microbicides. The MRC also works with RK Kha Hospital, which is about 20 miutes outside of Durba. MRC ad RK Kha Hospital have worked together o several cliical trials. page 50 Parterig for Care i HIV Prevetio Trials

78 2 Natioal AIDS Research Istitute (NARI), Pue, Idia Pue lies east of Mumbai (Bombay) i Idia s wester state of Maharashtra, ad was home to more tha four millio people i Accordig to UNAIDS, less tha 1 percet of the Idia populatio was HIV positive i Although the Natioal AIDS Cotrol Orgaizatio provides ART free of cost at govermetal hospitals i six high-prevalece states, icludig Maharashtra, oly 10 percet of the people who eed ART get it. The govermet-sposored NARI study site was established i 1992, ad it icludes oe o-site cliic ad laboratory, ad six off-site cliics aroud the city. Four of those sites are at hospitals, ad oe is at the Natioal Istitute of Virology. The other cliic is i Pue s red-light district. The NARI site focuses o both care ad research programs. For example, NARI has participated i several HPTN trials, primarily oes for serodiscordat couples. Uiversity of North Carolia Project (UNC Project), Tidziwe Cetre, Lilogwe, Malawi Lilogwe is Malawi s capital ad is home to more tha half a millio people, accordig to the 2003 cesus. I 2005, the HIV prevalece for adults ages was just over 14 percet. This coutry provides free health care. I 1999, the Uiversity of North Carolia ad Kamuzu Cetral Hospital collaborated to form the UNC Project, which is located at the Tidziwe Ceter. This two-story buildig provides 20,000 square feet icludig a coferece room, exam rooms, a laboratory, a lecture hall, a library with olie access, ad a pharmacy o the Kamuzu Cetral Hospital grouds. The laboratory ca ru a rage of tests, icludig HIV testig, serum ad cell separatio ad storage, ad HIV viral-load testig. The UNC Project has ru several HPTN cliical trials, icludig tests of microbicides to prevet HIV ifectio ad studies of ART. This site also works o o-hptn studies, such as the Breastfeedig Atiretroviral ad Nutritio study. Appedices page 51

79 Uiversity of Pesylvaia, Philadelphia, Pesylvaia, USA Accordig to the 2000 cesus, more tha 1.5 millio people live i Philadelphia. The HIV prevalece rate i the Uited States was 0.6 percet i ART is available through may sources, icludig hospitals ad various treatmet ceters with public ad private fudig. Several programs icludig the Rya White CARE Act ad the Pesylvaia Drug Assistace Program assist HIV-positive patiets with the cost of care ad treatmet. Patiets ca also seek free care at health care ceters ru by the city of Philadelphia. I 1989, the HIV Prevetio Research Uit at the Uiversity of Pesylvaia Ceter for Addictio Studies started as a HIV Network for Prevetio Trials (HIVNET) site, ad ow it is a HPTN ad HIV Vaccie Trials Network (HVTN) site. This site focuses o HIV risk related to drug use ad sexual practices. The Uiversity of Pesylvaia site has participated i several HPTN cliical trials. These iclude trials o populatios that iclude wome at risk for HIV, itraveous drug users ad members of their sex ad drug etworks, ad serodiscordat couples. Uiversity of Zimbabwe Uiversity of Califoria, Sa Fracisco (UZ UCSF) Collaborative Research Programme, Harare, Zimbabwe Harare is the capital of Zimbabwe ad home to more tha 1.5 millio residets, early 3 millio i the overall metropolita area. The HIV prevalece rate i Zimbabwe was just over 20 percet i Of those who eed ART, oly about 7 percet receive it. Zimbabwe is ot a PEPFAR coutry, ad it receives o Global Fuds. This uiversity-based site a collaboratio betwee the Uiversity of Zimbabwe ad the Uiversity of Califoria, Sa Fracisco focuses o research. It icludes oe o-site cliic ad works with other off-site cliics. Give the limited access to ART i Zimbabwe, the HPTN site ofte tries to make referrals for treatmet for participats who scree out as HIV-positive durig recruitig for a trial. The UZ UCSF site has participated i may HPTN cliical trials. These iclude various study populatios, icludig high-risk but HIV-egative participats, me who have sex with me, wome at risk for HIV, serodiscordat couples, ad pregat HIV-positive wome. page 52 Parterig for Care i HIV Prevetio Trials

80 Appedix 3: Refereces 3 Global Campaig for Microbicides. Mappig the stadard of care at microbicide cliical trial sites. Prelimiary fidigs ad summary recommedatios. Washigto, DC: Global Campaig for Microbicides, Available at: Lodo, A. J. (2005). Justice ad the huma developmet approach to iteratioal research. The Hastigs Ceter Report 35(1): MacQuee, KM, McLoughli K, Allema P, et al. Parterig for Care i the HIV Prevetio Trials Network. Part I: Overall Fidigs. Research Triagle Park, North Carolia: Family Health Iteratioal, MacQuee, KM, McLoughli K, eds. Parterig for Care i the HIV Prevetio Trials Network. Part II: Case Studies. Research Triagle Park, North Carolia: Family Health Iteratioal, Participats i the 2006 Georgetow Uiversity Workshop o the Acillary-Care Obligatios of Medical Researchers Workig i Developig Coutries. The acillary-care obligatios of medical researchers workig i developig coutries. PloS Medicie 2008; 5(5):e90. Available at: Peterso L, Taylor D, Roddy R, et al. Teofovir disoproxil fumarate for prevetio of HIV ifectio i wome: A phase 2, double-blid, radomized, placebo-cotrolled trial. PloS Cliical Trials 2007;2(5):e27. Available at: article/ifo:doi%2f %2fjoural.pctr Appedices page 53

81 Raymod EG, Taylor D, Cates W Jr, et al. Pregacy i effectiveess trials of HIV prevetio agets. Sexually Trasmitted Diseases 2007;34(12): Richardso, HS. Gradatios of researchers obligatio to provide acillary care for HIV/AIDS i developig coutries. America Joural of Public Health 2007; 97(1): UNAIDS. Guidelies o Protectig the Cofidetiality ad Security of HIV Iformatio: Proceedigs from a Workshop. Geeva, Switzerlad: Joit Uited Natios Programme o HIV/AIDS, Available at: cofidetiality_security_iterim_guidelies_15may2007_e.pdf. UNAIDS/WHO AIDS Epidemic Update. Geeva, Switzerlad: Joit Uited Natios Programme o HIV/AIDS, Available at: KowledgeCetre/HIVData/EpiUpdate/EpiUpdArchive/2007/default.asp. UNAIDS/WHO. Ethical Cosideratios i Biomedical HIV Prevetio Trials. Geeva, Switzerlad: Joit Uited Natios Programme o HIV/AIDS, Available at: UNAIDS/AVAC. Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials. Geeva, Switzerlad: Joit Uited Natios Programme o HIV/AIDS, Available at: guidelies_e.pdf. page 54 Parterig for Care i HIV Prevetio Trials

82 Appedix 4: Checklist Local Obstacles ad Issues 4 I creatig a health care system for participats i a cliical trial for HIV prevetio, plaers as well as trial sposors, fuders, ad others should uderstad local cultural orms. To assess these orms, plaers ca cosider the topics listed i the checklist below. I additio, this checklist ecourages cliical trial plaers to evaluate specific obstacles ad issues, as well as seek ways to overcome or resolve such costraits. Checklist Guidelies Public Health Goals: For the study populatio or local commuity, list the key public health goals, how these goals could affect the cliical trial, ad possible approaches to gettig the most from the trial i cojuctio with the local populatio goals. Views o HIV/AIDS: List the most commo poits of view i the local populatio regardig HIV/AIDS (e.g., fear, discrimiatio, etc.), potetial impacts o the trial (e.g., causig potetial participats to fear associatio with a HIV/AIDS study) or the participats (e.g., beig shued by other commuity members for participatig), ad possible solutios to related obstacles. Health Care Views: List the most commo perspectives o health care i geeral amog commuity members (e.g., Are they iclied more toward traditioal remedies or moder medicie? Are they ope to public health educatio?), how this could affect the trial (e.g., ifluecig local opiios about the value of a give trial), ad what tools might be used to work with local health care views. Appedices page 55

83 Treatmet Cocers: List ay treatmets or forms of health care (e.g., cotraceptio) that are uacceptable, restricted, or stigmatized locally, potetial impacts (e.g., participats ot practicig safe sex), ad how trial leaders or staff might hadle such obstacles. Social Costraits: List ay local ecoomic or political issues that could affect the trial or its participats, the possible impacts (e.g., a reductio i local health care facilities), ad how trial plaers or sposors could resolve these issues. page 56 Parterig for Care i HIV Prevetio Trials

84 4 Checklist Local Obstacles ad Issues Public Health Goals Top Goals Potetial Impacts o the Trial Possible Solutios Views o HIV/AIDS Commo Viewpoits Potetial Impacts Possible Solutios Health Care Views Key Perspectives Top Impacts Possible Solutios Treatmet Cocers Treatmets Potetial Impacts Possible Solutios Social Costraits Top Costraits Top Impacts Possible Solutios Appedices page 57

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86 Appedix 5: Checklist Public Health System Costraits 5 The health care that ca be provided with ay cliical trial depeds o a rage of costraits i the surroudig system of public health. To assess challeges ad opportuities related to a specific cliical trial i a particular locatio, cosider the items listed below. I additio, fill i the blaks to provide a framework i which to develop a trial s health care system. Checklist Guidelies Basic Needs: List basic eeds that may be lackig i the trial s area (e.g., utritio, housig, clea water), the likely impact of these basic eeds o the participats ad the trial, ad potetial parterships or other ways to improve these coditios. Commo Medical Needs: List the most commo medical diseases or coditios i the trial area, the top likely impacts of these medical eeds o the participats ad the trial itself, ad potetial solutios to ay egative impacts. Local Medical Resources: List the available facilities (e.g., cliics, pharmacies, etc.), the impacts that these facilities could geerate for trial participats or the services that trial staff might eed to cover, ad how to resolve ay related problems. Local Service Limitatios: List the key shortcomigs i local health care services (e.g., limited available testig or treatmets, particularly at specific sites), how these shortcomigs will affect trial participats (e.g., travelig for some health care or ot receivig it), ad ways to improve these situatios. Appedices page 59

87 Likely Treatmets Needed: List the top treatmets that trial participats (ad family members) will probably eed, how this could affect the participats or the trial (e.g., requirig extra fudig), ad how to provide these treatmets. Ecoomic Costraits: Note the top ecoomic costraits (e.g., lack of health isurace) faced by trial participats, the crucial impacts o participats (e.g., ot receivig some eeded care), ad what efforts could improve this situatio. Political Costraits: Determie ay govermet chages that might affect health care for trial participats (e.g., dissolutio of health care programs), the potetial impact o the participats, ad possible solutios. Fudig Opportuities: List potetial sources (e.g., oprofit health care orgaizatios, govermet bodies, PEPFAR, Global Fud, etc.) of additioal fudig for health care for trial participats, what fuds or resources to request, ad how to approach these sources. page 60 Parterig for Care i HIV Prevetio Trials

88 5 Checklist Public Health System Costraits Medical Issues Basic Medical Need Top Needs Top Impacts o the Trial Possible Solutios Commo Medical Needs Top Diseases/ Coditios Top Impacts Possible Solutios Local Medical Resources Available Facilities Top Impacts Possible Solutios Local Service Limitatios Key Shortcomigs Top Impacts Possible Solutios Likely Treatmets Needed Top Treatmets Top Impacts Possible Solutios cotiued o ext page Appedices page 61

89 Checklist Public Health System Costraits, cotiued from previous page Socioecoomic Issues Ecoomic Costraits Top Costraits Top Impacts Possible Solutios Political Costraits Key Issues Top Impacts Possible Solutios Fudig Opportuities Possible Resources Possible Fuds Steps for Cotact page 62 Parterig for Care i HIV Prevetio Trials

90 Appedix 6: Checklist Egagig the Commuity 6 The success of ay cliical trial for a HIV prevetio strategy depeds o a strog workig relatioship with the local commuity. This relatioship ca attract participats to the trial, reveal possible referral parterships, ad improve the log-term health care of trial participats ad others i the commuity. The steps outlied i the checklist below ca help trial plaers to icorporate commuity ivolvemet from the start. Checklist Guidelies Target Populatio: List the eligibility criteria for the research project(s) to be implemeted i the commuity ad the umbers of me, wome, ad childre (miors) to be erolled. Commuity Ivolvemet Plas: List the goals of egagig the commuity (e.g., desired iteractios), how a trial hopes to reach those goals, ad the expected beefits (e.g., erollig participats, icreasig referral parterships). Commuity Ivolvemet Fudig: List items related to commuity ivolvemet (e.g., developig a commuity advisory coucil), provide a budget for each item, ad ote the iteded source of the fudig. Commuity Ivolvemet Staff: Name the positio usually oe perso who works as a liaiso betwee a cliical trial ad the local commuity ad list expected duties or obligatios. Appedices page 63

91 Commuity Advisory Board (CAB): List the desired categories of members (e.g., diverse commuity members, local govermet leaders), ote cotacts who might put cliical trial leaders i touch with members i each category, ad list the actual members of the coucil as they are added. For guidace o establishig commuity advisory mechaisms such as a CAB, see the UNAIDS/AVAC documet Good Participatory Practice Guidelies for Biomedical HIV Prevetio Trials. Review: Note the frequecies ad forms of reviews betwee the cliical trial leaders ad the local commuity (e.g., mothly meetigs with the commuity advisory board or biaual tow meetigs ). page 64 Parterig for Care i HIV Prevetio Trials

92 Checklist Egagig the Commuity 6 Target Populatio Commuity Ivolvemet Plas Eligibility Criteria Erollmet Targets Me Wome Childre (Miors) Goals Techiques Desired Outcome Commuity Ivolvemet Fudig Item Fudig Source Commuity Ivolvemet Staff Positio Obligatios Commuity Advisory Board Desired Members Cotacts for Members Actual Members Review Frequecy Form Appedices page 65

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94 Appedix 7: Checklist Care ad Treatmet Package 7 I the plaig stage of a cliical trial for the prevetio of HIV, leaders should develop a health care package for participats. Usig this form, plaers ca create a checklist of treatmets to provide, as well as specific details related to the treatmet. Checklist Guidelies Treatmet: List each treatmet that will be provided as part of a cliical trial s health care package. Recipiets: Who will receive the treatmet? Is it oly for trial participats? Will it be available to others (e.g., those who scree out or family members of participats)? Source: Who will provide this treatmet? Will it come from trial staff (i.e., direct treatmet) or from a referral group (i.e., idirect treatmet)? Duratio: Determie how log a treatmet will be provided. Will it oly be available durig the cliical trial? Will the treatmet or care also be available for a prescribed period after the trial? Fudig: Note how the care ad treatmet will be fuded. Will the cliical trial iclude a budget item for this care ad treatmet? Will the trial plaers arrage with aother group to fud this health care? Appedices page 67

95 Checklist Care ad Treatmet Package Treatmet Recipiets Source Duratio Fudig page 68 Parterig for Care i HIV Prevetio Trials

96 Appedix 8: Checklist Creatig a Referral System 8 To develop a referral system, use the followig checklist for geeral guidace. Direct Determie the sources of various forms of care ad treatmet Idirect Arrage trial-site space ad staff time for care ad treatmet Key Factors: Capabilities Proximity Resources Locate Referral Parters to hadle Idirect Care Examples of what might be provided from trial leaders: Ifrastructure Fudig Staff Time Supplies Traiig Agree o expectatios Examples of what might be provided from parters: Testig Treatmet Psychosocial support Draft agreemets i writig (e.g., Memoradum of Uderstadig) Develop referral system Features: Formal Referral Procedure (e.g., paperwork delieatig referral eeds) Mechaism to deliver participats to referral site Follow-up procedure Appedices page 69

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98 Appedix 9: Checklist Resources to Implemet 9 The followig is a list of the kids of resources that are likely to be eeded to implemet the seve steps. Step Resource Mechaism Who Timeframe 1: Build a public health attitude amog research leaders ad staff Formal ad iformal commuicatio; traiigs; icetives Pricipal ivestigator as primary lead with active ivolvemet of other staff Ogoig 2: Assess the local commuity s values, attitudes, ad priorities Commuity assessmet or formative research prior to trial implemetatio Social scietist plus additioal team members as eeded 3 moths (excludig ay required approvals) 3: Assess the assets ad costraits of the public health system Commuity assessmet or formative research prior to trial implemetatio Public health evaluator, commuity health evaluator, or social scietist with commuity/public health experiece plus additioal team members as eeded 4 6 weeks (excludig ay required approvals) cotiued o ext page Appedices page 71

99 Checklist Resources to Implemet, cotiued from previous page Step Resource Mechaism Who Timeframe 4: Egage the commuity Commuity advisory board or other formally costituted group plus iformatio-sharig evets (such as meetigs, ewsletters, or radio spots) as appropriate Commuity liaiso officer ad pricipal ivestigator plus other staff as eeded Ogoig 5: Determie the extet of care to provide Systematic review of protocol combied with results of previous steps Pricipal ivestigator, cliical research staff, commuity advisory board with iput from research goverace bodies 2 4 weeks 6: Build relatioships with earby resources Formal meetigs with leadership at cliics, hospitals, service orgaizatios, etc.; iformatio-sharig; resource-sharig; ad voluteerig Pricipal ivestigator, study coordiator, commuity liaiso officer plus other staff as appropriate Ogoig 7: Develop a referral system Memorada of agreemet or uderstadig with referral orgaizatios; moitorig of effectiveess Health couselor(s), pricipal ivestigator, plus other staff as appropriate Ogoig page 72 Parterig for Care i HIV Prevetio Trials

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101 Natioal Istitute of Allergy ad Ifectious Diseases