PrEP for Adolescents: SUCCESSES, CHALLENGES & OPPORTUNITIES 11/18/2015

Transcription

1 meetig report

2 PrEP for Adolescets: table of cotets Foreward...1 Executive Summary... 2 Opeig Remarks... 3 Da O Coell, Director, New York State Departmet of Health AIDS Istitute... 3 Demetre Daskalakis, Assistat Commissioer, Bureau of HIV Prevetio ad Cotrol, New York City Departmet of Health ad Metal Hygiee... 3 Ivited Speaker Presetatios... 4 Bill Kapogiais: ATN 110 Cliical Trial Results... 4 Susa Rosethal: Adolescet Autoomy ad Decisio-Makig... 5 Lillia Rivera: Imagiig a Tomorrow with Choices...6 Paymet Optios for Adolescet PrEP...6 Summary of Pael Discussio: Experieces Implemetig PrEP i Adolescet Cliics...6 Table 1: Overview of Paelists Adolescet PrEP Program Implemetatio Paelists Shared Successes, Challeges, ad Priorities Summary of Breakout Sessio Discussios ad Report Out...12 Sessio I: Coset, Paymet, ad Access to Care...12 Issues ad Challeges Proposed Solutios ad Chages Top Priorities for Improvemet i the Next 3-5 Years Sessio II: Likage to Care ad Retetio...13 Issues ad Challeges Proposed Solutios ad Chages Top Priorities for Improvemet i the Next 3-5 Years Sessio III: Cliical Care Issues ad Challeges Proposed Solutios ad Chages Top Priorities for Improvemet i the Next 3-5 Years Coclusios: Key Issues ad Priorities for Chage to Expad Access To ad Implemetatio of Adolescet PrEP i NYS...15 Appedices A. Meetig Ageda B. Laws Cocerig Medical Treatmet of Miors ad Coset I New York State...17 C. Attedees This report was prepared by Mary Beth Hase, MA, Project Director, Johs Hopkis Uiversity HIV Cliical Guidelies Program, February 2016

3 PrEP for Adolescets: foreword Ly Steves, MS, NP, ACRN Deputy Director, Office of the Medical Director, AIDS Istitute, ad Forum Director I November 2015, the New York State Departmet of Health AIDS Istitute coveed the first forum to brig together stakeholders from across the state to discuss the uique issues associated with providig PrEP for adolescets egaged i high-risk behaviors. We ivited PrEP providers, public health officials, ad commuity members represetig a wide variety of perspectives to cotribute isights gleaed from their experieces with deliverig PrEP services to adolescets i diverse settigs. The day s discussio focused o idetifyig successes to date, policy issues, ad cliical practice challeges i deliverig PrEP to adolescets, ad o opportuities to expad PrEP for adolescets statewide i support of the NYS Ed the Epidemic by 2020 iitiative. Ivited speakers, who icluded researchers, cliicias, ad service delivery providers, preseted backgroud o the cliical, psychological, ad social service evidece supportig adolescet PrEP ad shared data ad lessos leared from their experiece. Attedees the participated i each of 3 breakout sessios to address issues they idetified i advace as key to implemetatio of adolescet PrEP statewide: 1) coset, paymet, ad access; 2) likage to care ad retetio; ad 3) cliical care. First oted by AIDS Istitute Director Da O Coell i his opeig remarks, those themes domiated the day s discussios, ad all agreed that coset, paymet, ad access to care must be addressed i tadem to esure New York State s success i deliverig PrEP to high-risk adolescets over the ext 5 years. Successes realized to date were ackowledged as well. Providers reported steadily icreasig umbers of patiets o PrEP who stay o PrEP. Cliical trials have idicated that PrEP is effective ad safe ad that adolescets are good cadidates for PrEP. AIDS Istitute fudig to support PrEP specialists has bee a resoudig success. The greatest opportuities for chage idetified by participats were i the realms of policy ad regulatios; fudig; ad educatio for youg people, commuity members, ad cliical practitioers. The day s discussio idetified a immediate eed for dissemiatio of iformatio o paymet optios, as it was made clear that may attedees believe that private ad public PrEP paymet optios are ot readily available for adolescets. However, this is ot the case. Though Gilead s paymet assistace program is ot ope to miors, other optios are available ad accessible. The success of evets like this forum always depeds o the time, thought, ad effort of may. The people resposible for plaig, logistics, materials desig ad productio, veue coordiatio, registratio, ote-takig, facilitatio of ad reports o breakout sessios, ad trascriptio of otes icluded Mary Elle Reo, Je O Coor, the Johs Hopkis Uiversity Cliical Guidelies team, Marcia Kidlo, Toa Nguye, Tracy Hatto, Doa Parisi, Kraig Paell, Dora Swa, Carme Vasquez, Laura Dugga Russell, Felicia Schady, Da Tietz, ad Beth Yurchak. Thak you all for makig the day a great success. This is a excitig time. We ow have a prove method for prevetig ew HIV ifectios i some of the most vulerable people i New York State. Idetifyig our successes to date, the challeges to ogoig success, ad priorities for chage i deliverig PrEP to high-risk adolescets throughout New York is a importat step i the right directio. 1

4 PrEP for Adolescets: executive summary forum o adolescet prep: successes, challeges & opportuities This report summarizes speaker presetatios ad the pael ad participat discussios at the first statewide forum o implemetatio of pre-exposure prophylaxis (PrEP) for adolescets, which was hosted by the New York State Departmet of Health AIDS Istitute (NYSDOH AI) o November 18, O Jue 29, 2014, Goveror Adrew Cuomo aouced a 3-poit pla to accelerate the ed of the HIV/AIDS epidemic i New York State. A key compoet of this pla is to icrease the accessibility ad uptake of PrEP for high-risk HIV-uifected idividuals. PrEP implemetatio for adults was addressed o August 26, 2015, whe the NYSDOH AI coveed a forum, atteded by healthcare providers, cosumers, commuity stakeholders, ad state ad local health officials, to discuss the use of PrEP ad PrEP quality of care for adults i New York State. The November 18, 2015, forum o adolescet PrEP was desiged as a compaio evet to address challeges ad opportuities specific to the adolescet populatio. Presetatios ad discussios focused o 5 key areas: 1. Issues ad challeges uique to PrEP implemetatio for adolescets 2. Keys to success, icludig best practices for egagig adolescets 3. Policies eeded to icrease adolescet access to PrEP statewide 4. Priorities for chage to guaratee success i the ext 3 years There was ear uaimity regardig the most importat issues ad challeges ad equal agreemet o top priorities for chage to esure success i expadig PrEP implemetatio i the ext 3-5 years: 1. Update Public Health Law/Regulatios Older adolescets ca coset to PrEP; youger adolescets/miors should be grated the legal right to coset to PrEP. Regulatory relief should be provided to protect miors from uwated disclosure to parets by isurace compaies that isist o mailig preauthorizatio ad explaatio of beefits (EOB) documets to parets address. 2. Icrease Fudig ad Raise Awareess of Available Paymet Optios Expad PrEP-AP to iclude coverage for medicatios. Editor s ote: PrEP-AP curretly covers the cost of cliic visits ad laboratory tests but does ot pay for medicatios. Esure that care providers are aware of ad able to access all available optios for paymet. Icrease public fudig for PrEP implemetatio ad access. 3. Frame Key Issues More Effectively Coset ad paymet are health issues, ot civil rights issues the ability to coset to PrEP is ecessary to protect the health of ad avoid harm to miors. PrEP is a public health issue the iability to access PrEP is a threat to the health of those at risk of acquirig HIV, which may, i tur, pose a threat to the public s health. HIV prevetio is aalogous to pregacy prevetio. 4. Expad Traiig ad Educatio For care providers to esure adequate umbers ad geographic distributio of pediatricias ad primary care physicias with the kowledge ad willigess to prescribe PrEP, ad to esure that emergecy physicias have the kowledge ecessary to prescribe post-exposure prophylaxis (PEP) whe it is idicated. Amog youg people to reduce stigma, ecourage cocer for sexual health ad egagemet i care, ad build kowledge of optios for egagig i healthy sex. Throughout commuities to ecourage support of PrEP ad to ormalize discussios of sex, sexual idetity, ad sexual health. 5. Expad Outreach to Youth Use a wide variety of outreach approaches to greatly expad efforts to idetify youth who could beefit from PrEP, icludig youger adolescets/miors. Egage commuity parters ad resources to reach ad support youg people. Create iovative programs ad messagig to reach adolescets ad customize messagig ad outreach efforts for the differet age groups withi adolescece. Youger adolescets ad older miors are developmetally differet from each other ad from older adolescets/youg adults. Employ mobile ad ew techologies to egage ad assist adolescets with adherece to PrEP treatmet ad associated cliic visits. 2

5 PrEP for Adolescets: summary of speaker presetatios opeig remarks Da O Coell Director, New York State Departmet of Health AIDS Istitute The AIDS Istitute Director opeed the forum by likig PrEP to prevet HIV ifectio to Goveror Cuomo s 3-poit pla to ed the AIDS epidemic by The State has set the goal of reducig ew ifectios from 3,000 to 750 aually by the ed of The umber of ew ifectios has declied steadily, ad ow the availability of a effective, safe, ad maageable biomedical itervetio offers great hope for achievig the goal for Providig PrEP to persos who egage i high-risk behaviors to prevet them from acquirig HIV is oe of the 3 pillars of the State s iitiative. Toward that ed, the State s blueprit recommedatios for PrEP ad for post-exposure prophylaxis (PEP) call for a statewide educatio campaig, icreased distributio ad access statewide, ad statewide mechaisms to track ad measure uptake. O Coell ackowledged the policy challeges to icreasig miors access to PrEP, highlighted the issues of coset ad cofidetiality, ad stressed that efforts are uderway to idetify regulatory chages to allow miors to coset to their ow care ad prevetio services. The issues of coset to care, access, paymet, ad educatio were the primary themes of the day s discussios. Demetre Daskalakis, MD, MPH Assistat Commissioer, Bureau of HIV Prevetio ad Cotrol, New York City Departmet of Health ad Metal Hygiee Dr. Daskalakis stressed the importace of applyig lessos leared i providig atiretroviral therapy for adolescets to implemetig PrEP for adolescets ad emphasized that New York City ad New York State have forged a strog, complemetary workig relatioship that has greatly expaded access to HIV care. Daskalakis described New York State as fertile groud for providig biomedical itervetios ad social services to prevet HIV. He asserted that care should be status eutral ad that the goals of care, for people who are ad are ot HIV-ifected, should be to test more, treat more, ad egage youth i care, ideally, before they start takig risks. Egage youth i care before they have egaged i risky behaviors. With that, Daskalakis poited out that guidelies ad cliical studies, with their emphasis o youth who have already egaged i high-risk behavior, focus o the past o behavior that has already occurred. He proposed lookig forward to aticipate the activity of adolescets ad empower them to make choices i advace. Accomplishig that, Daskalakis urged, requires early, ucostraied, ad cotiuous dialogue with adolescets about life chages, sexuality, sexual health, ad optios, especially because it ca be very difficult for adolescets to aticipate behavior that they have ever egaged i or bee close to. Daskalakis ecouraged educatig adolescets i advace so they kow the optios available to them whe eeded ot because they are plaig to put themselves i harm s way, but so they ca protect themselves if ad whe protectio may be eeded. He ultimately observed that youth is itself a health disparity deservig of careful cosideratio. The ultimate goal, said Daskalakis, should ot be makig sure that adolescets take pills; istead, the goals should be to egage adolescets i carig for their bodies, icrease their awareess of risk, ad provide them with the meas to protect themselves whe they are at risk ad the ability to recogize whe their seaso of risk is over ad they o loger eed PrEP. 3

6 PrEP for Adolescets: ivited speaker presetatios Bill Kapogiais, MD Adolescet Medicie Trials Network for HIV/AIDS Itervetios, Natioal Istitutes of Health (NIH), Bethesda, MD PrEP adherece was greater amog YMSM who were most susceptible to HIV ifectio. A HIV PrEP Demostratio Project ad Phase II Safety Study for Youg MSM i the US: Notig that the NIH recogizes the dearth of PrEP safety ad efficacy data for youg me who have sex with me (YMSM), Dr. Kapogiais discussed the results of ATN 110, a trial that icluded 200 US adolescets (18 to 22 years) who, as YMSM, were appropriate cadidates for PrEP. All were HIV atibody-egative at the time of screeig ad all self-reported high-risk for acquirig HIV i the previous 6 moths. Evidece of high-risk icluded the followig: Codomless aal itercourse with a HIV-ifected male parter or with a male parter of ukow status Aal itercourse with 3 or more male sex parters Exchage of moey, gifts, shelter, or drugs for aal sex with a male parter Sex with a male parter ad has had a sexually trasmitted ifectio (STI) Sexual parter of a HIV-ifected male with whom codoms were ot cosistetly used At least oe episode of aal itercourse durig which the codom broke or slipped off The majority of participats were Black (53%); 21% were White, 17% Hispaic/Latio, 2% Asia/Pacific Islader, ad 7% were other/mixed race. The mea age was years. Most (77%) of the participats idetified as gay; 13.7% idetified as bisexual. After PrEP was dispesed, follow-up visits occurred at weeks 4, 8, 12, 24, 36, ad 48, at 12 study sites located throughout the US. Kapogiais reported that PrEP was well-tolerated, with miimal adverse evets. The umber of STI diagoses was high to start ad remaied so throughout the study. With 4 serocoversios through week 48, HIV icidece was high, but the researchers posit that, give the high rate of STIs, the serocoversio rate likely would have bee higher i the absece of PrEP. Participats who serocoverted had udetectable drug levels, idicatig lack of adherece with the PrEP regime. However, participats who egaged i codomless sex had higher drug levels, idicatig that adherece was greater amog the participats who were most susceptible to HIV ifectio. Though geerally good, adherece varied by race/ethicity, with the lowest levels occurrig amog Black YMSM (BYMSM). Amog all participats, adherece declied as the iterval betwee study visits icreased, with a otable drop after week 12, whe the iterval betwee visits icreased from 4 weeks to 12. This fidig suggests that youth may eed more frequet or loger visits with providers, with i-perso meetigs augmeted by cotact via mobile techologies. The researchers also called for more research ad greater uderstadig of barriers to PrEP access ad adherece, particularly amog BYMSM ad other high-risk populatios. Kapogiais also reported o boe chages amog the study participats, otig that boe loss is the primary toxicity of the combiatio teofovir/emtricitabie (TDF/FTC; brad ame Truvada), which is used for PrEP. Results idicated that boe mass was lower at baselie tha expected amog study participats, ad boe loss was modest. The effects of boe mass loss i adolescets, before peak boe desity is achieved, is a cocer. Additioal research is eeded to determie if boe mass losses reverse oce PrEP is discotiued. 4

7 PrEP for Adolescets: Susa Rosethal, PhD, ABPP Director, Divisio of Child ad Adolescet Health, Columbia Uiversity, New York, NY The most sigificat differece betwee adolescets ad adults is legal status. Adolescet Autoomy ad Decisio-Makig: Implicatios for Prescribig PrEP: Dr. Rosethal opeed her presetatio by ackowledgig that the prospect of prescribig PrEP for adolescets may ispire fear amog care providers. She recommeded cultivatig a sese of excitemet (rather tha fear) because of the opportuity PrEP offers, ad she provided isights ito characteristics of adolescets ad their behavior to help alleviate providers fears. Rosethal stressed that adolescet autoomy icludes the right to give aother perso decisio-makig resposibilities. Treatig adolescets as if they have dimiished autoomy ad reflexively deferrig to parets or surrogates assumes, perhaps icorrectly, that others have cogitive abilities to make decisios ad the desire to act i adolescets best iterests. Because adolescets abilities to make autoomous decisios are idividual ad situatio-specific, some adolescets are capable of cosetig to PrEP. NY State law grats the right to coset to ay type of health care to some miors, icludig those who are emacipated, married, have childre, or are assessed to be mature, as desigated ad documeted by a health care provider. All miors have the right to coset to reproductive health care, testig ad treatmet for STIs, ad testig for HIV. But all miors do ot curretly have the right to coset to HIV treatmet, PrEP, ad other health ad prevetio care. Rosethal emphasized that adolescece is ot a uiform state. It covers a wide rage of ages, with dramatic variaces i maturity withi ad amog age groups. I geeral, mature judgmet appears to develop betwee the ages of 16 ad 19 years, ad impulsivity declies betwee the ages of 15 ad 30 years. Adolescets may be more vulerable to risk-takig, but, she explaied, research does ot suggest great differeces betwee adolescets ad other age groups. Practical Suggestios to Support Adolescets i Accessig PrEP: Settig: Provide a space that is welcomig ad comfortable for adolescets ad that is safe for youg people who idetify as lesbia, gay, bisexual, trasgeder, or queer (LGBTQ). Esure that staff ad care providers are traied to work with ad are comfortable with adolescets, have positive attitudes, clear boudaries, ad uderstad their roles. Providers should avoid adoptig the role of either paret or peer. Extra time should be accommodated i scheduled appoitmets for adolescets. Decisio-makig: Support adolescets i their decisio-makig by addressig such questios as: Do they see PrEP as appropriate? Does it match their behavior? Do they see themselves as beig at risk? Do they have a HIV-ifected parter? Do they admit to ijectio drug use? Do they believe that PrEP works ad is a good optio for them? Do they believe they ca remember to take the medicatio every day ad keep their appoitmets? PrEP adherece: This is especially importat if adolescets do ot wish to disclose that they are takig PrEP. Whe this is the case, adolescets may eed help plaig how to store ad access their medicatios while maitaiig their cofidetiality. Providers should help adolescets idetify ways to remember PrEP every day, such as tyig it to showerig, teeth brushig, or other daily routies. Also importat is helpig adolescets maitai adherece betwee times of sexual activity. Ulike codoms, PrEP is ot liked to havig sex per se, so adolescets may eed help ad support i maitaiig adherece eve whe they are ot sexually active. Keepig appoitmets: Support adherece to PrEP-related medical appoitmets by addressig ad troubleshootig reasos for missig cliic appoitmets, ad assist i plaig to keep appoitmets. I closig, Rosethal emphasized that the most sigificat differece betwee adolescets ad adults with regard to PrEP is their legal status (ot, as may believe, developmetal or social factors) because legal status impedes access, coset, ad paymet. 5

8 PrEP for Adolescets: Lillia Rivera, MPH The Ceter for LGBTQ Youth Advocacy ad Capacity Buildig, Hetrick-Marti Istitute, New York, NY Create political will by demostratig the cost-effectiveess of PrEP vs. a lifetime of HIV care Imagiig a Tomorrow with Choices: Mappig a Trajectory for YMSM Access to PrEP Based o the History of Reproductive Justice: I describig the approach to youth ad sexual health take by the Hetrick-Marti Istitute, Ms. Rivera stressed the importace of cotext, ad i so doig, ecouraged a sharp focus o the eeds of youth. Specifically, she urged a holistic approach that provides access to high-quality sexual health care ad helps youth develop a healthy sese of their sexuality. She stressed that doig so will ecourage youg people to recogize the importace of sexual health. Rivera described a approach focused o creatig access to choices for youth, with o barriers, by providig accurate, youth-targeted iformatio, public educatio, ad advocacy. She emphasized the eed to create political will by, for istace, demostratig the cost-effectiveess of PrEP versus a lifetime of HIV care. Rivera also ecouraged a focus o health promotio, rather tha risk ad harm prevetio. This idea was uderscored durig the questio-ad-aswer sessio whe all 3 preseters cofirmed the difficulty of askig adolescets to predict their behavior, which is ofte ot possible because sexual behavior may be ew. Paymet Optios Are Available for PrEP for Adolescets Throughout the day s discussios, may participats reported that they fid it difficult, if ot impossible, to secure paymet for PrEP for adolescets. There are private ad public paymet optios available, ad there are some commo misperceptios about coverage. This shared difficulty poits to the eed to educate providers about paymet optios, which is a priority for the AIDS Istitute. We strogly ecourage care providers to cosult with colleagues, with the AI, ad with other public resources whe assistace is eeded to secure paymet for adolescets. pael discussio: experieces implemetig prep i adolescet cliics paelists: Doa Futterma, MD, Director, Adolescet AIDS Program, Childre s Hospital at Motefiore, Brox, NY Jeffrey M. Birbaum, MD, MPH, Executive Director, HEAT Program, SUNY Dowstate Medical Ceter, Brookly, NY David Rosethal, DO, PhD, Medical Director, Northwell Ceter for Youg Adult, Adolescet ad Pediatric HIV, Great Neck, NY Uri Belkid, MD, MS, Cliical Director of Health Outreach to Tees (HOTT), Calle-Lorde Commuity Health Ceter, New York, NY Paelists were ivited to discuss their experieces i implemetig PrEP for adolescets i 4 differet cliical settigs ad were asked to describe the followig aspects of their programs: Utilizatio: Number of patiets served, demographics, uique characteristics, ad recruitmet Service model: Support team, providers, special traiig, likages, fudig, ad uique issues (e.g., adherece, social services, medical services) Metrics: Performace data, quality measures, ad outcomes Successes: Key achievemets ad uique aspects of the program Challeges: Key challeges to PrEP implemetatio A overview of paelists presetatios is preseted i Table 1. 6

9 PrEP for Adolescets: Table 1: Overview of Paelists Adolescet PrEP Program Implemetatio ADOLESCENT AIDS PROGRAM, CHILDREN S HOSPITAL AT MONTEFIORE, BRONX, NY PRESENTER: DONNA FUTTERMAN, MD, DIRECTOR Utilizatio Service Model Metrics Successes Challeges Priorities for Chage 7/ /2015: 31 screeed; 14 cliically assessed; 7 prescribed PrEP; 3 waitig for PrEP 58% Black; 33% Latio; 10% White 52% male; 13% female; 35% trasgeder 35% gay; 26% straight; 13% pasexual; 13% bisexual; ad 13% other Policy ad procedure based o Ceters for Disease Cotrol ad Prevetio (CDC) ad NYSDOH guidace Attedig physicia, NPs, 2 PrEP specialists (social worker ad LPN); all staff received CME traiig Cliical referrals from medical providers; likage agreemets with CBOs; word-ofmouth; parter referrals; packaged with other cliical services, such as hormoes ad STI screeig Paymet: private isurace, Medicaid, Gilead patiet assist, NYS PrEP-AP, private fud for mior ad uisured; to date, o deials from private isurers Percetage screeed, assessed, ad prescribed Retetio i care Adherece self-report Serocoversios Patiet satisfactio Qualitative assessmet of facilitators ad barriers Dedicated PrEP specialists Primary care as gateway to PrEP Cotiued egagemet of patiets ot iitially iterested Flexibility with visits Improved psychosexual health Barriers to uptake: low perceptio of risk, adherece, paretal disclosure, other medical priorities, ot ready Private isurace: prior authorizatio, high co-pays, required mail-order pharmacy, EOBs that threate cofidetiality Multiple follow-up visits Isurace coverage for miors Paretal coset waiver Icreased access i primary care settigs Scaled up routie HIV testig Greater uderstadig of how to motivate ad commuicate with youth about PrEP 7

10 PrEP for Adolescets: Table 1: Overview of Paelists Adolescet PrEP Program Implemetatio, cotiued HEAT PROGRAM, SUNY DOWNSTATE MEDICAL CENTER, BROOKLYN, NY PRESENTER: JEFFREY M. BIRNBAUM, MD, MPH, EXECUTIVE DIRECTOR Utilizatio Service Model ~125 HIV-ifected youth, aged years; much larger umber of o-hiv-ifected youth for HIV ad STD screeig 28 assessed for PrEP; 8 iitiated; 6 cotiued o PrEP; 1 lost to follow-up; 1 uable to start due to isurace/cofidetiality issues Youth who are isured by parets ad related issues of coset ad cofidetiality are issues uique to this populatio PrEP target populatio icludes parters of HIV-ifected youth Broad recruitmet amog all HIV-ifected cliic patiets ad targeted outreach to YMSM ad trasgedered youth i commuity settigs, icludig house ball commuity Priciples of adherece same as for HIV care for adolescets Team icludes PrEP specialist, peer outreach staff, 3 medical providers, case maagemet ad metal health services Commuity outreach to LGBTQ youth orgaizatios; i-reach ad traiig provided to hospital medical staff AI-fuded PrEP specialist makes direct cotact with youth, schedules appoitmets, remids, ad assesses isurace status Populatio is geerally high-risk youth, ofte homeless, ofte difficult to egage i care, umet metal health eeds Metrics Bega measurig performace i AIRS 2/2015 Medical ecouter forms for medical services related to PrEP Adherece to quarterly visit schedule Cosiderig use of quarterly lab measures No serocoversios to date Keepig ay patiet o PrEP protocol for 6 moths Successes Challeges Priorities for Chage Program is up ad ruig (with AI support) Patiets who are started o PrEP are adheret with regime ad visits Exteral referrals Buy-i from house ball commuity Uisured youth ad difficulty with securig paymet for adolescets. Youth uable to access their isurace iformatio from parets (cofidetiality ad sesitivity issues) Loss of cofidetiality due to EOB letters High-risk miors caot coset to treatmet i New York Lack of iformatio about PrEP amog some of the highest-risk youth Stigma about HIV amog youth, especially i house ball commuity Access Paymet 8

11 PrEP for Adolescets: Table 1: Overview of Paelists Adolescet PrEP Program Implemetatio, cotiued NORTHWELL CENTER FOR YOUNG ADULT, ADOLESCENT AND PEDIATRIC HIV, GREAT NECK, NY PRESENTER: DAVID ROSENTHAL, DO, PHD, MEDICAL DIRECTOR Utilizatio New PrEP referrals are icreasig: 2 i 2013, 13 i 2014, 25 as of September 2015 Overwhelmig majority of PrEP patiets are MSM, with small umbers of heterosexual ad trasgeder youth 62% of referrals are from commuity parters; 15% from the commuity va; 10% from patiets parters; small umbers from the iteret, physicia referral, schools, etc. Wide variety of commuity parters i Quees ad Nassau College ad public health outreach were ot high-yield, or was advertisig eed to target message better Social media ad apps are crucial Successes Challeges Priorities for Chage Steady icrease i referrals HIV testig va with AI-fuded PrEP specialist talkig about PrEP every possible way Commuity parterships, which are key for referrals Traiig care providers about PrEP Care provider traiig broadly ot just for people who take care of patiets with HIV ifectio Fudig cotiuity ad sustaiability: start-up grats are great, but oce fudig priorities shift, there is o way to maitai programs Not doig great with PrEP amog adolescets much more eergy ad resources are eeded Youg me uder 20 are ot very willig to egage with PrEP; their good itetios get i the way (e.g., I am goig to start usig codoms every time I have sex ) Great eed for ew workig relatioships/collaboratios with differet sectors of healthcare system ad withi healthcare systems (i.e., i-patiet service ofte is discoected/uaware of out-patiet service) Directio eeded from the State o EMR carve-out for sexual health iformatio for 13- to 17-year-old patiets; access to iformatio blocked to care providers Expaded fudig for PrEP Make likage to PEP for emergecies much easier ad less cumbersome; PEP for emergecies is crucial true harm reductio; iitiate PEP starter packs; PEP eeds to be see as equally importat as PrEP 9

12 PrEP for Adolescets: Table 1: Overview of Paelists Adolescet PrEP Program Implemetatio, cotiued CALLEN-LORDE COMMUNITY HEALTH CENTER, MANHATTAN, NY PRESENTER: URI BELKIND, MD, MS, CLINICAL DIRECTOR OF HEALTH OUTREACH TO TEENS (HOTT) Utilizatio Service Model Successes Challeges 148 PrEP patiets: 91 from HOTT; 57 adults 55% White; 13% Black; 10% other; 22% o respose; 32% Hispaic 87% male; 11% trasgeder; 2% other 3 PrEP specialists who are part of the HIV prevetio ad outreach team; they hadle HIV couselig ad testig, PrEP outreach ad couselig, staff traiig, PrEP-AP applicatios, ad Gilead MAP applicatios HOTT medical providers, triage urse, sexual health cliic, SPARK project PrEP protocol: 1) iitial visit (history, labs, STI screeig, couselig); 2) adherece assessmet; 3) first follow-up; 4) every 3 moths follow-up PrEP support services: HOTT triage urse, case maagers, ad PrEP specialists Fudig: Isurace, PrEP-AP, grats (AI, NYSDOH, SPARK-NIH) PrEP is viable optio for older adolescets ad youg adults Participatio is similar to that of other groups Multiple optios for accessig ad obtaiig PrEP Multidiscipliary teams with cross-traiig ad collaboratio Commuity outreach, icludig i house ball commuity Equal access to services across racial ad geder barriers Youger patiets more likely to be uisured ad have cofidetiality issues Coset: law is ot clear regardig miors ability to coset to prevetio 10

13 PrEP for Adolescets: PANELISTS SHARED SUCCESSES, CHALLENGES, AND PRIORITIES From the pael discussio, a clear picture of shared successes, challeges, ad priorities for chage emerged. Shared successes icluded the additio of AI-fuded PrEP specialists, who all paelists agreed were istrumetal i program implemetatio. All reported steadily icreasig umbers of patiets o PrEP ad reported that those who have started PrEP have, for the most part, stayed with it. Traiig for care providers was also reported as a success, as was icreasig exteral referrals ad expadig commuity parterships for outreach ad referrals. Three domiat themes emerged as challeges ad priorities for chage: Coset: Older adolescets/youg adults are able to coset to PrEP, but may miors (age 17 ad youger) caot. Regulatory chage is eeded to allow miors to coset. Limited paymet optios: Paelists reported that paymet optios are limited, particularly because adolescets ofte caot readily access parets isurace coverage. Whe they ca, doig so may jeopardize their cofidetiality if isurace compaies isist o mailig documetatio, such as EOBs, to policy holders (i.e., parets) homes. Limited access: Youth access to PrEP is limited because of coset ad paymet issues, because there are ot eough providers who ca prescribe PrEP, ad because there are ot eough resources to reach youth who eed PrEP ad egage them i care. I additio, coferece participats stressed the followig: 1) cocer that a relatively small umber of adolescets girls are receivig PrEP whe there are may who are havig sex with YMSM; 2) the ogoig eed for educatio because may adolescets do ot kow how HIV is trasmitted ad acquired. SUCCESSES CHALLENGES & PRIORITIES AI-fuded PrEP specialists Miors caot coset to PrEP Steadily icreasig umbers of patiets o PrEP Limited paymet optios Adolescets stayig o PrEP Protectio of cofidetiality whe usig private isurace Exteral referrals Regulatory relief to icrease access to PrEP Expadig commuity parterships Difficulties ad misoceptios related to paymet optios Traiig for care providers Not eough providers to prescribe PrEP 11

14 PrEP for Adolescets: SUMMARY OF BREAKOUT SESSIONS AND REPORT OUT Meetig participats were divided ito 3 groups ad ivited to rotate through 3 breakout sessios, each of which addressed topics idetified i advace as importat to ay discussio of adolescet PrEP implemetatio. Groups were facilitated by AIDS Istitute staff, who the reported o the groups resposes whe asked to idetify the followig: Issues ad challeges uique to PrEP implemetatio for adolescets Keys to success, icludig best practices for egagig adolescets Policies eeded to icrease adolescet access to PrEP statewide Priorities for chage to guaratee success i the ext 3 years The ideas expressed ad the coclusios draw i the group discussios largely echoed the cocers ad coclusios of all speakers ad preseters. sessio i: coset, paymet, ad access to care PrEP is a public health issue, ot a civil rights issue. Issues ad Challeges Idetified by Participats: Most miors (age 17 ad youger) are ot able to coset to PrEP. Emacipated miors, miors with childre, ad miors assessed as beig mature by care providers are the exceptios. If a care provider documets i his/her assessmet that a mior is mature, the the mior ca coset to PrEP. The legal defiitio of adult is ot clear ad should be clarified from the top dow, i.e., i guidace from the CDC ad the Food ad Drug Admiistratio (FDA). A mechaism for waivig paretal coset is eeded; requirig paretal coset for PrEP (ad HIV treatmet) may violate adolescets cofidetiality ad prevet them from seekig PrEP. Private isurace compaies ad mail-i prescriptio services may ot be willig to refrai from deliverig documets that may violate adolescets cofidetiality to parets (e.g., EOBs, preauthorizatio forms, ad prescriptio order receipts). Paymet optios ad access are limited. Adolescets may have difficulty accessig their isurace coverage without disclosig to their parets. More resources ad support are eeded. Much time ad effort is required i workig with adolescets to arrage paymet, to egotiate with isurace compaies to take steps to protect adolescets cofidetiality, ad to support adherece. Navigatig the labyrithie logistics of paymet/coverage ca be time cosumig, ad egotiatios are ot always successful. Participats Proposed Solutios ad Chages: Take actio ow for the future by revisig regulatios to allow miors to coset to PrEP ad to other prevetio measures, such as the huma papillomavirus (HPV) vaccie, ad to HIV treatmet. There is precedet: miors are able to coset to treatmet of STIs ad to family plaig. Revise Article 23 to iclude HIV amog STIs, but exempt HIV from the statute that crimializes trasmissio of STIs. Make broader use of the mature mior provisio to prescribe PrEP for miors. Icrease public fudig to pay for PrEP for adolescets. Accommodate loger cliic visits ad provide more resources ad support to address all of the issues that atted PrEP for adolescets. Lobby to chage isurace compay rules regardig home delivery of coverage-related materials for adolescets; establish easier mechaisms for requestig that isurace compaies deliver materials to alterate addresses. Expad efforts to idetify youg people who are i eed of PrEP. Doig so requires avoidig commo ad stereotypical coceptios of risk ad expadig educatio ad outreach throughout the commuity, most especially i schools, pharmacies, ad healthcare systems. Establish a risk stratificatio strategy i guidelies to help idetify those with whom PrEP should be discussed. The AIDS Istitute should take the lead i promotig use of PrEP ad makig clear that the beefits outweigh ay risks. 12

15 PrEP for Adolescets: Participats Top Priorities for Next 3-5 Years to Improve Coset, Paymet, ad Access to Care for Adolescet PrEP: Chage the laguage of Article 23 to iclude HIV as a STI, but exempt HIV from statutes that crimialize trasmissio. Build commuity support for these chages. Expad PrEP-AP to cover adolescets. Editor s ote: Although PrEP-AP does ot cover the cost of medicatios, the program does cover the cost of cliic visits ad laboratory tests. Grat adolescets the ability to coset to care ad expad coverage of PrEP for adolescets at the same time. Coset without access to paymet will ot be helpful. Coduct more cliical trials to push the FDA toward approval of FTC/TDF for use as PrEP i idividuals uder 18 years of age. Reframe the key issues: 1) PrEP is to protect health; therefore, the ability to coset to PrEP is required to protect adolescets health ad to avoid harm to miors; 2) PrEP is a public health issue, ot a civil rights issue; therefore, the health of those uable to access PrEP is threateed, which may, i tur, threate the public s health; 3) prevetio of HIV is aalogous to prevetio of pregacy. sessio ii: likage to care ad retetio PrEP is a public health issue, ot a civil rights issue. Issues ad Challeges Idetified by Participats: Our culture prioritizes health care for sickess, ot for prevetio to stay healthy. Adolescece is ot geerally a time of illess, ad adolescets do ot see themselves as i eed of health care. Our culture also does ot support or ecourage ope discussio of sex, sexuality, ad sexual health. As a result, discussios of prevetio are focused o risk, ad discussios of sex are medicalized, which may ot be a effective approach for youth. Issues of access, coset, paymet, ad cofidetiality pose barriers to PrEP for adolescets. Public health messagig ad the curret public health approach to PrEP for adolescets reflects ambivalece. The message eeds to be clear ad uambivalet: PrEP is for healthy sex. There are ot eough care providers who are kowledgeable about, able, ad willig to prescribe PrEP, particularly i rural areas. Participats Proposed Solutios ad Chages: Widespread traiig of pediatricias ad primary care providers to expad awareess of PrEP ad access issues. Oe approach may be to make PrEP traiig ad competecy a requiremet for licesure. Make starter packs available that provide a 14- or 30-day supply of FTC/TDF to esure that patiets retur for follow-up care. Expad ad ehace the use of digital techologies to create multiple chaels for reachig, egagig, ad retaiig youth i care. Create iovative adherece tools. Adopt ew, clear approaches to messagig for youth (e.g., PrEP is for healthy sex) Expad the capacity of healthcare facilities to welcome ad accommodate youg people. Goig to a cliic, especially a cliic i a hospital, is a adult activity that may adolescets are ot prepared to do o their ow. Expad sesitivity traiig to improve cliical eviromets for LGBTQ youth. Expad ad support parterships betwee ad amog health system etities, commuity-based orgaizatios, ad other commuity parters. Ivolve schools to a much greater degree for educatio ad health service delivery. Improve access to city ad state data to help care providers locate patiets i eed of PrEP ad to locate patiets for follow-up. The AI should idetify ways to use its data system to close loopholes i the referral/appoitmet/attedace process. 13

16 PrEP for Adolescets: Participats Top Priorities for Next 3-5 Years to Improve Likage to Care ad Retetio for Adolescet PrEP: Revise public health laws to address coset, access, ad paymet barriers. Educate healthcare providers to expad their awareess ad kowledge of PrEP; esure traiig across multiple specialties (e.g., pediatrics, primary care, emergecy medicie), ot just amog HIV care providers. Cosider a mechaism to tie PrEP traiig ad competecy to licesure. I the approach to adolescets, focus o sexual health. Pilot-test iovative programs, icludig expaded use of peers ad peer avigators. Implemet school-based cliics. sessio iii: cliical care Addressig coset ad paymet issues is labor-itesive ad time-cosumig. Issues ad Challeges Idetified by Participats: Issues of coset, cofidetiality, access, ad paymet pose barriers to PrEP for adolescets. HIV is ot, but should be, cosidered a STI for regulatory purposes. Adolescets eed extraordiary support for successful adherece, icludig more frequet ad loger visits with care providers, icetives to keep appoitmets, ovel approaches to remidig youth to take medicatios, ad sesitivity to special circumstaces, such as a eed to maitai cofidetiality. It is labor-itesive ad time-cosumig to avigate issues of coset ad paymet for adolescets. Adolescets ofte lack the health ad sexual health literacy ecessary to demad PrEP ad/or to uderstad the requiremets associated with PrEP, such as screeig ad lab testig. Healthcare providers discomfort with discussig sex ad sexuality with adolescets may lead them to avoid the ogoig dialogue ecessary to promote adolescet sexual health. There are ot eough care providers with the kowledge ad willigess to prescribe PrEP. Participats Proposed Solutios ad Chages: Expad traiig to esure adequate umbers of care providers who are kowledgeable, able, ad willig to prescribe PrEP for adolescets; there is a great eed for PrEP providers i rural areas i particular. Tailor PrEP cliic settigs, hours, ad approaches to the eeds of adolescets by: 1) expadig cliic hours; 2) providig sesitivity traiig to all staff ot just cliical staff; 3) makig effective use of mobile techologies to reach ad egage youg people through multiple chaels; 4) legtheig ad icreasig the frequecy of visits as idividual eeds dictate; ad 5) expadig commuity parterships ad settigs i which PrEP ca be accessed. Tailor PrEP-related messagig to adolescets of various ages ad to delivery i a wide variety of settigs; create effective campaigs to icrease health literacy amog youth. Provide support ad traiig for care providers to icrease their comfort i addressig sex, sexuality, ad healthy sex with youth. Develop icetives that are meaigful to adolescets to support ad reiforce their egagemet with care ad adherece. Make starter packs available to provide a 14- or 30-day supply of FTC/TDF ad esure that patiets retur for follow-up care. Address regulatory issues that impede prescribig PrEP for miors ad expad PrEP-AP to cover PrEP ad vacciatios for miors. Update guidelies to iclude adolescet-specific recommedatios that address the followig: 1) idetificatio of cadidates for PrEP through risk stratificatio; 2) more frequet (every 3 moths) STI screeig; 3) icreased frequecy of PrEP follow-up visits to esure coverage for mothly visits if they are eeded; ad 4) lab work, routie health maiteace, ad metal health ad substace use screeig. Participats Top Priorities for Next 3-5 Years to Improve Cliical Care for Adolescet PrEP: PrEP ad sexual health traiig for care providers, begiig i medical school. Revise public health law to address issues of coset, paymet, ad access. Update guidelies to address adolescet-specific key issues (specifics oted above). Expad health educatio for youth, ad iclude educatio tailored specifically to youger adolescets. Use multiple chaels ad iovative approaches to egage ad retai youg people i care. 14

17 PrEP for Adolescets: CONCLUSIONS: key issues ad priorities for chage to expad access to ad implemetatio of prep for high-risk adolescets i ew york state The 3 domiat themes that emerged as challeges ad priorities for chage durig the pael discussio were also emphasized by participats durig the breakout sessio discussios: 1) miors are ot able to coset to PrEP ad NYS regulatory chage is eeded to allow mior coset; 2) paymet optios are limited because adolescets caot readily access isurace, ad paymet programs such Gilead assistace do ot cover prescriptios for miors; ad 3) access is limited by coset ad paymet issues, by the small umbers ad limited geographic distributio of providers who will/ca prescribe PrEP, ad by isufficiet resources to reach the youth who eed PrEP ad to egage them i care. Attedees were i broad agreemet that the top priorities for chage to esure success i expadig PrEP implemetatio i the ext 3-5 years should be: 1. Update Public Health Law/Regulatios Grat miors the legal right to coset to PrEP. Provide regulatory relief to protect miors from uwated disclosure to parets by isurace compaies that isist o mailig preauthorizatio ad EOB documets to parets address. 2. Icrease Fudig ad Expad Paymet Optios Expad PrEP-AP to iclude coverage for medicatios i additio to curret coverage of cost of cliic visits ad laboratory tests for miors ad clarify laguage. Icrease care providers kowledge of ad ability to access all available optios to pay for PrEP for adolescets. Icrease public fudig for PrEP implemetatio ad access. 3. Frame Key Issues More Effectively Coset ad paymet are health issues, ot civil rights issues the ability to coset to PrEP is ecessary to protect adolescets health ad to avoid harm to miors. PrEP is a public health issue the iability to access PrEP is a threat to the health of those at risk of acquirig HIV, which may, i tur, pose a threat to the public s health. HIV prevetio is aalogous to pregacy prevetio. 4. Expad Traiig ad Educatio Trai care providers, to esure adequate umbers ad geographic distributio of pediatricias, primary care physicias, ad emergecy physicias with the kowledge ad willigess to prescribe PrEP. Educate youg people, to reduce stigma, ecourage cocer for sexual health ad egagemet i care, ad to build kowledge of optios for egagig i healthy sex. Educate commuity members, to ecourage support of PrEP ad to ormalize discussios of sex, sexual idetity, ad sexual health. 5. Expad Outreach to Youth Use a wide variety of outreach approaches to greatly expad efforts to idetify youth who could beefit from PrEP. Egage commuity parters ad resources to reach ad support youg people. Create iovative programs ad messagig to reach youth. Employ mobile ad ew techologies to egage ad assist adolescets with adherece to PrEP treatmet ad associated cliic visits. 15

18 PrEP for Adolescets: APPENDIX A: MEETING AGENDA 9:00 AM 9:30 AM Registratio, Cotietal Breakfast, Networkig 9:30 AM 9:40 AM Welcome ad Itroductios: Ly Steves, MS, NP, ACRN, Deputy Director, Office of the Medical Director, NYSDOH AIDS Istitute 9:40 AM 9:50 AM Opeig Remarks: Da O Coell, Director, NYSDOH AIDS Istitute 9:50 AM 10:00 AM Opeig Remarks: Demetre Daskalakis, MD, Assistat Commissioer of the Bureau of HIV Prevetio ad Cotrol, NYC DOHMH part i: ivited speakers 10:00 AM 10:30 AM ATN 110: A HIV PrEP Demostratio Project ad Phase II Safety Study for Youg MSM i the US Bill Kapogiais, MD, Adolescet Medicie Trials Network for HIV/AIDS Itervetios, NIH 10:30 AM 11:00 AM Adolescet Autoomy ad Decisio-Makig: Implicatios for Prescribig PrEP Susa Rosethal, PhD, ABPP, Director, Divisio of Child ad Adolescet Health, Columbia Uiversity 11:00 AM 11:30 AM Imagiig a Tomorrow with Choices: Mappig a Trajectory for YMSM Access to PrEP Based o the History of Reproductive Justice Lillia Rivera, MPH, The Ceter for LGBTQ Youth Advocacy ad Capacity Buildig, Hetrick-Marti Istitute 11:30 AM 12:00 PM Questios ad Aswers 12:00 PM 12:15 PM Break: Pick up luch ad retur for pael discussio part ii: workig luch with pael discussio 12:15 PM 1:00 PM PrEP Implemetatio i a Adolescet PrEP Cliic 1:00 PM 1:15 PM Questios ad Aswers Doa Futterma, MD, Adolescet AIDS Program, Childre s Hospital at Motefiore Jeff Birbaum, MD, Heat Program, SUNY Dowstate David Rosethal, DO, PhD, Northwell Ceter for Youg Adult, Adolescet ad Pediatric HIV Uri Belkid, MD, MS, Health Outreach to Tees (HOTT), Calle-Lorde part iii: roud-robi breakout sessios 1:15 PM 2:45 PM Participat Discussios: Attedees will circulate through three 25-miute breakout sessios to discuss their experieces with the followig key topics i adolescet PrEP implemetatio: coset, paymet, retetio, adherece, sexual health, ad cliical care. After 25 miutes of discussio i oe sessio, participats will be directed to the ext sessio util everyoe has had the opportuity to participate i each of the 3 sessios. After a short break, we will gather to report out ad idetify priorities for policy ad chage. 2:45 PM 3:00 PM Break part iv: priorities for policy ad chage: reports from breakout sessios 3:00 PM 3:45 PM Report Out: Successes, Challeges ad Priorities for Chage: Sessio leaders will report out to the whole group with the goal of idetifyig the top 3-5 items i each of the followig areas: Issues ad challeges uique to PrEP implemetatio for adolescets Keys to success, icludig best practices for egagig adolescets Policies eeded to icrease adolescet access to PrEP statewide Priorities for chage to guaratee success i the ext 3 years 3:45 PM 4:00 PM Next Steps ad Closig Remarks: Ly Steves 16

19 PrEP for Adolescets: APPENDIX B: LAWS CONCERNING MEDICAL TREATMENT OF MINORS AND CONSENT IN NEW YORK STATE TOPIC Coset for Medical Treatmet i Geeral, Icludig HIV Treatmet NEW YORK PUBLIC HEALTH LAWS AND DESCRIPTION PHL 2504 provides that paretal or guardia coset is geerally required for a physicia to treat a perso who is uder 18, icludig for HIV/AIDS. However, there are exceptios: 2504(1): A perso who is a) 18 or older; b) the paret of a child; or c) has married may give coset for medical, detal, health ad hospital services for himself or herself, ad the coset of o other perso shall be ecessary; 2504(3): A perso who is pregat may give coset for medical, detal, health ad hospital expeses relatig to preatal care; 2504(4): Medical, detal health ad hospital services may be redered to persos of ay age without the coset of a paret or legal guardia whe i the physicias judgmet a emergecy exists ad the perso is i immediate eed of medical attetio ad a attempt to secure coset would result i delay of treatmet which would icrease the risk to the perso s life or health. 2504(6): Ayoe who acts i good faith based o the represetatio by a perso that he or she is eligible to coset pursuat to the terms of this sectio shall be deemed to have received effective coset. HIV Screeig HIV Treatmet of Survivors of a Sexual Offese 2781: A HIV-related test may ot be ordered without the iformed coset of the subject, if the subject has the capacity to coset, or, if he/she does ot, the coset of a perso authorized to coset to health care for the subject. However, PHL 2780 provides that the capacity to coset to HIV testig meas a idividual s ability, determied without regard to the idividual s age, to uderstad ad appreciate the ature ad cosequeces of a proposed health care service, treatmet, or procedure, or of a proposed disclosure of cofidetial HIV related iformatio, ad to make a iformed decisio i(1)(c): Every hospital providig treatmet to alleged victims of a sexual offese is resposible for offerig ad makig available appropriate post HIV-exposure treatmet therapies i cases where it is determied, i accordace with guidelies issue by the commissioer that sigificat exposure to HIV has occurred. STD Screeig ad Treatmet 2305: A licesed physicia may diagose, treat or prescribe for a perso uder 21 without the coset or kowledge of the parets or guardia of said perso, where such perso is ifected with a sexually trasmitted disease, or has bee exposed to ifectio with a sexually trasmitted disease. 2311: Requires the Commissioer of DOH to promulgate a sexually trasmitted disease list. HIV is ot o the list. 17: Records cocerig the treatmet of a mior for a sexually trasmitted disease or the performace of a abortio upo such mior patiet shall ot be released or made available to the paret or guardia of such mior. 17