Office of HIV/AIDS Network Coordination

Transcription

1 Office f HIV/AIDS Netwrk Crdinatin 2019 Wrk Plan (Year 13) December 1, 2018 Nvember 30, 2019 Intrductin... 3 Majr Crss-Netwrk Prjects... 5 Infrastructure and Administrative Supprt... 9 HANC Staff Rle... 9 The HANC Public Website The HANC Cllabratr Prtal Scial Netwrking & Infrmatin Sharing Clinical Research Supprt Cntract Objectives and Activities by Area f Crdinatin Behaviral Science Crdinatin Cmmunicatins Wrking Grup Cmmunity Crdinatin Data Management Center Crdinatin Evaluatin Crdinatin Financial Disclsure Database Labratry Crdinatin Legacy Prject Netwrk Leadership Site Management Crdinatin Training Resurces Wmen s HIV Research Cllabrative (WHRC) HANC Activity Updates Appendix I: Tangible Deliverables by Area f Crdinatin: Behaviral Science Crdinatin Cmmunicatins Wrking Grup Cmmunity Crdinatin Data Management Center Crdinatin Evaluatin Crdinatin Financial Disclsure Database... 32

2 Labratry Crdinatin Legacy Prject Site Management Crdinatin Training Resurces Wmen s HIV Research Cllabrative (WHRC) HANC Activity Updates HANC 2019 Wrk Plan 2 f 34 Finalized: December 13, 2018

3 Intrductin The Office f HIV/AIDS Netwrk Crdinatin (HANC) wrks with the HIV/AIDS Clinical Trials Netwrks funded by the U.S. Natinal Institutes f Health (NIH) with the intent f creating a mre integrated, cllabrative, and flexible research structure. The Netwrks are an affiliated grup f natinal and internatinal medical research institutins and investigatrs that cnduct clinical HIV/AIDS research. They include the AIDS Clinical Trials Grup (ACTG), the HIV Preventin Trials Netwrk (HPTN), the HIV Vaccine Trials Netwrk (HVTN), the Internatinal Maternal Pediatric Adlescent AIDS Clinical Trials Grup (IMPAACT), and the Micrbicide Trials Netwrk (MTN). The NIH HIV/AIDS Clinical Trials Netwrks have been designed t address NIAID s five HIV/AIDS scientific pririties: 1. Therapeutics fr HIV/AIDS and HIV-assciated infectins in adults (including HIV cure, as well as c-ccurring nninfectius and infectius diseases, including hepatitis and tuberculsis) (ACTG) 2. HIV/AIDS and HIV-assciated infectins in children and mthers (IMPAACT) 3. Integrated strategies t prevent HIV infectin (HPTN) 4. Vaccines t prevent HIV infectin (HVTN) 5. Micrbicides t prevent HIV infectin (MTN) HANC is based at the Fred Hutchinsn Cancer Research Center in Seattle, Washingtn and has prvided leadership and lgistical supprt fr crss-netwrk crdinatin effrts since HANC s missin is t supprt the science and peratins f the netwrks by increasing efficiency and resurce sharing thrugh crdinatin f critical activities acrss netwrks and with ther research and advcacy partners. Effrts fcus n crss-netwrk crdinatin, cmmunity and behaviral sciences, including: scientific leadership; site management and research lgistics; labratry peratins; crdinatin f data management; develpment and applicatin f cnsistent standards f perfrmance evaluatin; and facilitating effective cmmunity engagement in the research prcess, including the Legacy Prject. HANC is accuntable in its activities t the Netwrk Leadership and DAIDS. This HANC 2019 Wrk Plan utlines crss-netwrk crdinatin bjectives and activities fr the perid f December 1, 2018 Nvember 30, 2019 (Year 13). The bjectives, strategies and activities detailed herein have been develped in cnsultatin with each f the relevant wrk grups. The dcument is intended t cmmunicate and guide crdinatin effrts at a high level. Prgress in meeting bjectives will be mnitred, cmmunicated, and revised as needed n a regular basis by HANC staff, as utlined n pages HANC 2019 Wrk Plan 3 f 34 Finalized: December 13, 2018

4 This is the rganizatinal chart fr HANC: HANC 2019 Wrk Plan 4 f 34 Finalized: December 13, 2018

5 Majr Crss-Netwrk Prjects Area Behaviral Science Behaviral Science Grup Respnsible Behaviral Science Cnsultative Grup Behaviral Science Wrking Grup and HANC staff Objective Prvide cnsultatin as requested t the NIH HIV/AIDS Clinical Trials Netwrks n the behaviral and scial science cmpnents f their research agenda and studies: including but nt limited t, advice n prtcl design, prtcl implementatin and methdlgy fr data cllectin, and evaluatin Maintain a repsitry f measures, data frms, and standardized cre elements f interventins Intended Impact Increase the behaviral/scial science cmpnents f netwrk studies. Facilitate sharing f infrmatin and state-f-thescience practices. Timeline and Cmpletin Target Onging Onging Behaviral Science HANC staff Maintain Behaviral Science Interest Grup alias and resurce center fr netwrk-affiliated behaviral and scial scientists. Circulate ntice f imprtant tls, measures, CRFs, meeting ntices, and articles. Hst tpics f interest webinar series. Onging Behaviral Science Yuth Preventin Research Wrking Grup Identify, cllabrate, and address matters related t internatinal adlescent (ages 12-24) HIV preventin research; cnduct training and webinars n related research tpics Increased prmtin and sharing f netwrk adlescent research agendas, strategies, and resurces. Onging Cmmunicatins Cmmunicatins WG Leverage netwrk experience and expertise; cllect cmmunicatins tls and measures; harmnize elements f the netwrks cmmunicatins plans Increased crdinatin and cnsistent messaging. Onging HANC 2019 Wrk Plan 5 f 34 Finalized: December 13, 2018

6 Area Cmmunity Crdinatin Grup Respnsible Cmmunity Partners Objective Facilitate and enhance cmmunity representatin and input at all levels in HIV/AIDS and related clinical research within the netwrks. Increase knwledge and awareness f CP, CP tls, and netwrk activities. Supprt efficiency and effectiveness f lcal and netwrk cmmunity advisry bards and engagement f stakehlders. Address challenges t cmmunity engagement in clinical research. Intended Impact Prvide input and recmmendatins t fcus n meeting CP s Strategic Plan bjectives t guide CP s wrk ver the next three years fllwing the Netwrk restructuring. Timeline and Cmpletin Target Onging Cmmunity Crdinatin Cmmunity Partners Research Pririties Wrking Grup Onging discussins t imprve and prmte transgender inclusin as utlined in the CP Memrandum, including wrking with DAIDS, the Netwrks and ther grups t encurage adptin and implementatin f the recmmendatins. Review and make recmmendatins regarding Standard f Care issues fr cmmunity members. In partnership with CP Ethics WG, review and address understanding f IC amng CABs. Cntinue t review and make recmmendatins n c-endrsed prtcls t ensure cmmunity input. Enable invlvement in the develpment and sharing f research pririties, and harmnizatin between cmmunity and investigatr research pririties. Onging Cmmunity Crdinatin Cmmunity Training Wrking Grup Develp a strategy t disseminate and prmte new r standardized crss-netwrk Cmmunity Partners training materials t Netwrks, Sites, and ther cmmunity grups. Assess the value f materials and determine additinal pririty tpics. Wrk t make CP training mdules n the DAIDS LMS available in an pen access frum. Share existing CAB training materials; identify and integrate material and develp new r standardized crss-netwrk CAB training materials when there are unmet training needs r a strng ratinale fr standardized mdules. Onging HANC 2019 Wrk Plan 6 f 34 Finalized: December 13, 2018

7 Area Cmmunity Crdinatin Grup Respnsible Cmmunity Ethics Wrking Grup Objective CP will identify pprtunities fr imprvement and wrk in cllabratin with DAIDS t prvide guidance t researchers, cmmunities and stakehlders regarding the ethical cnsideratins and challenges in research with individuals facing stigma, discriminatin, legal sanctins and/r interpersnal vilence, and scial harms. Intended Impact Review tpics acrss netwrks; identify areas where there are prblems r pprtunities fr imprvement and wrk in cllabratin with the Netwrk Leadership and DAIDS t address thse issues. Timeline and Cmpletin Target Onging Data Management Data Management Evaluatin DMC Wrking Grup DMC Wrking Grup Evaluatin Cmmittee Cnvene mnthly telecnferences t discuss varius nging data quality assurance prjects, identify areas fr imprvement, prvide recmmendatins, and implement as apprpriate. Biannually review the Infrmatin Technlgy Best Practice Standards (currently under revisin as f Q4 2018). Discuss pprtunities t harmnize timelines and frmats f evaluatin reprts acrss the netwrks with a fcus n cmmunity engagement. Prvide an pen frum fr the DMCs t discuss and identify cmmn issues fr reslutin. Ensure that sites meet minimum IT infrastructure standards t supprt clinical trials and infrastructure changes d nt negatively impact data management systems used by the DMCs. Identify streamlined and harmnized reprting prcesses. Onging Onging Onging Financial Disclsure Database Financial Disclsure Wrking Grup Wrk clsely with netwrk staff and DAIDS fficers t review the harmnized financial disclsure requirements and maintain the crss-netwrk web-based reprting interface. Crdinated slicitatin minimizes burden n sites, peratin center staff, and investigatrs required t reprt. Cntinue t imprve and adapt the SOP and secure nline system fr ease f use and clarity, and t ensure cncrdance with federal regulatins Onging HANC 2019 Wrk Plan 7 f 34 Finalized: December 13, 2018

8 Area Infrastructure and Admin Supprt Grup Respnsible HANC staff Objective Generate and review website and prtal user statistics and member survey data t infrm HANC prgrammatic and prtal imprvements. Intended Impact Imprved cmmunicatin and access t infrmatin t supprt decisin-making and cmpletin f crss-netwrk bjectives. Increase awareness f nging HANC crdinatin activities and ptential new pprtunities. Timeline and Cmpletin Target Onging Labratry Crdinatin VQAAB, CPQA Ensure standard quality assurance fr all the prtcl-specified assays cnducted in NIH-spnsred netwrk clinical trials acrss netwrks and ther partners thrugh the Ttal Quality Management (TQM) Prgram. Maintain data integrity f perfrmed assays by testing fr prficiency and tracking quality cntrl standards. Develp prficiency testing prgrams fr nn-clia assays that can feasibly reflect its perfrmance status in terms f technical skills as well as data measurement. Onging Labratry Crdinatin LFG, PBMC SOP WG, CCGWG Identify and address pprtunities t harmnize labratry prcesses and prcedures t reduce redundancy, increase efficiency and clarify expectatins, especially at shared site labratries at the lab technician level. Cnserve resurces fr all netwrks by cmbining purchasing pwer, prviding subject expertise, and cllabrating effrts in prjects that benefit the netwrks as a whle and individually. Onging Labratry Crdinatin ACTG/IMPAACT Lab Technlgist Cmmittee Identify and harmnize labratry prcesses and prcedures t reduce redundancy and increase efficiency at the lab technician level. Update SOPs in the ACTG/IMPAACT Labratry Manual. Cnserve resurces and effrts by creating standardized prcedures and methdlgies that can be utilized by crss-netwrk labs. Onging Legacy Prject Legacy Staff Build the capacity f dmestic cmmunities and researchers t equally partner in the research enterprise. Increased research literacy in dmestic cmmunities mst impacted by HIV and increased cultural awareness and respnsiveness f research staff and sites. Onging HANC 2019 Wrk Plan 8 f 34 Finalized: December 13, 2018

9 Area Site Management Lgistics Grup Respnsible Netwrk Leaders, OCSO, OPCRO, HANC Staff Objective Wrk clsely with netwrk staff, OCSO, OPCRO, ther DAIDS ffices t identify and address pririty site management issues. Intended Impact Imprve cmmunicatin and harmnized site peratins. Timeline and Cmpletin Target Onging Site Management Lgistics Site Crdinatrs Wrking Grup Discuss and address issues relevant t harmnizatin f plicies, prcedures and training at the site level acrss the netwrks cre peratins centers. Address issues f cmmn cncern and harmnize plicies and prcedures regarding site-level peratins. Onging Training Resurces Wmen s HIV Research Cllabrative HANC Staff Legacy Staff Maintain the training resurces public webpages. Prvide culturally apprpriate guidance and leadership in develpment, implementatin, and disseminatin f infrmatin abut HIV research fcused n and respnsive t the needs f cisgender and transgender wmen and girls in the US. Prvide infrmatin n varius training resurces fr site staff. Build capacity f wmen in the US t engage with DAIDS research; build capacity f DAIDS research enterprise t cnduct research with wmen in the US. Onging Onging Infrastructure and Administrative Supprt HANC Staff Rle HANC staff serve an administrative and prject management rle n each f the crss-netwrk cmmittees and wrking grups. As a wrking grup r cmmittee identifies areas f need r pprtunity, HANC staff are respnsible fr develping and mnitring an actin plan and dcumenting prgress and challenges. HANC staff identify individuals t take n each task and encurage the relevant wrking grup t sustain the effrt t cmplete the wrk, acknwledging that members participate in wrking grups and take n crss-netwrk tasks vluntarily, abve and beynd their respnsibilities within their primary rganizatin. HANC staff are respnsible fr setting call and meeting agendas, drafting and distributing materials, crdinating lgistics fr and chairing telecnferences and meetings, taking minutes and ensuring that actin items are cmmunicated, tracked and cmpleted. HANC staff manage HANC prtal team sites as a cllabrative space fr each wrking grup, develp web-based tls and train grup members hw t utilize them. HANC staff are an imprtant cnduit f infrmatin between different grups with ptential shared interest r verlap in activity. Additinally, HANC staff are cntinuusly cnsidering pprtunities fr crss-netwrk crdinatin and cllabratin. When they becme aware f such pprtunities they present them t the relevant wrking grup r bring them t the Netwrk Leaders and DAIDS and frm new wrking grups r ad hc task frces as apprpriate. HANC 2019 Wrk Plan 9 f 34 Finalized: December 13, 2018

10 The HANC Public Website The HANC public website ( cntains a calendar f events, netwrk newsletters, general infrmatin abut HANC s crdinatin activities, training resurces, labratry resurces, and ther resurces fr cllabratrs, research sites, and the general public, including: A dynamic calendar f scientific cnferences, netwrk meetings, cmmunity events, training pprtunities, and mre. Sme f the Divisin f AIDS Office f Clinical Site Oversight Clinical Research Plicies and Standard Operating Prcedures that are nt listed n the DAIDS website and a link t the fficial versins f all current DAIDS Clinical Research Plicies that are psted n the NIAID/DAIDS web site. A dynamic annuncement sectin n the hme page fr psting imprtant ntices, such as recent majr study results and DAIDS plicies. An HIV News sectin with the mst recent HIV news and research findings via RSS feeds. Infrmatin fr cmmunity members interested in supprting HIV/AIDS research as a cmmunity advisry bard member. Links t clinicaltrials.gv fr individuals interested in participating in a clinical research study. Free nline Gd Clinical Practice, Human Subjects Prtectin and Respnsible Cnduct f Research Training thrugh the Cllabrative IRB Training Initiative (CITI) and DAIDS Learning Prtal. A dynamic, searchable map shwing lcatins f netwrks and research sites arund the wrld. Infrmatin fr labratries, including PNL Cntact Assignments, prcedures, SOPs, and labratry training vides. A library f centralized labratry certificatins (i.e. CAP and CLIA) fr sites. Resurces and links t direct site and netwrk staff regarding wh t cntact r where t find the infrmatin they are lking fr, updated DAIDS rganizatin charts, and OCSO SOPs. Library f all the netwrk publicatins catalged in ne central lcatin fr ready access n the HANC public website, including netwrk press releases and respnses t study results such as iprex. Links t Netwrk websites and scial media cmmunicatin resurces. Resurces fr cmmunities including, but nt limited t: Recmmendatins fr Cmmunity Engagement in HIV/AIDS Research, American Indian Alaska Native Tw-Spirit HIV Preventin Research Mdule, Be The Generatin HIV Preventin Research Training Mdule, Basic Scientific Literacy Training Mdule, NAEHCR Prject Guidance and Best Practices Dcuments, and TB Resurces fr Cmmunities. HANC is explring an pprtunity t redesign the public website in Discussins with Fred Hutch s Cmmunicatin and Marketing Department have begun. The HANC Cllabratr Prtal The HANC prtal is an nline cllabrative envirnment fr crss-netwrk infrmatin sharing, dcument cllabratin, and knwledge management. The HANC prtal includes dcument libraries; dcument develpment and versin cntrl management tls; discussin and cllabrative areas (blgs, wikis, and discussin bards); calendaring and annuncements; databases; and a crss-netwrk directry linked t the DAIDS-ES Master Cntact system. In Octber f 2018, apprximately 1,421 individuals have active HANC prtal user accunts and 25 secure team sites are used by specific crss-netwrk wrking HANC 2019 Wrk Plan 10 f 34 Finalized: December 13, 2018

11 grups fr cllective dcument develpment, nline discussin, and sharing f materials and infrmatin. HANC regularly slicits suggestins fr the prtal and updates the site accrdingly. HANC prtal prjects fr the 2019 Wrk Plan include: Onging imprvements t the HANC Prtal and team site cntent t better supprt the bjectives f the wrking grups in Maintaining web services that make the DAIDS-ES Master Cntact system accessible t HANC prtal users. Publicizing the linkage t the DAIDS-ES prtcl reprt data and prtcl dcuments allwing ready access fr all HANC prtal users t this feature f the DAIDS-ES system. HANC prgram staff prvides prgrammatic updates n the Daily Dse annuncement bx. Cntinued ptimizatin f HANC Cntact Management System which integrates the prtal permissining, aliases, and cntact lists. HANC is in the prcess f upgrading t a new versin f SharePint fr the HANC Prtal. Scial Netwrking & Infrmatin Sharing HANC has Twitter (search fr Hancprgrams ), Facebk (search fr Hanc Prgrams ), and LinkedIn (search fr Office f HANC) accunts t share general prgrammatic updates with a brader audience. The HANC Legacy Prject maintains Facebk (@HANCLegacyPrject), Twitter (@HANC_Legacy), and Instagram (@HANC_Legacy) accunts t share cmmunity engagement resurces, training pprtunities, and prgrammatic updates with partners and the general public. HANC als publishes a mnthly newsletter that cntains HANC prgrammatic updates, netwrk updates, webinar events, meetings, and additinal resurces. In 2018, HANC cmpleted a redesign f the newsletter and will cntinue t slicit feedback t refine the publicatin in HANC will prvide individualized trainings fr netwrks and affiliated partners as requested. HANC regularly uses Ggle Analytics t track the mst used resurces and pages n bth the HANC public and prtal websites. Clinical Research Supprt Cntract The HIV Clinical Research Supprt (CRS) cntract between DAIDS and the cntract research rganizatin can be accessed by the netwrks t fund a variety f clinical research supprt tasks, frm mnitring study cnduct t prviding simultaneus translatin services fr meetings. Netwrks request netwrk-specific Clinical Research Supprt cntract thrugh their designated pint f cntact at DAIDS. Requests fr CRS services that apply acrss netwrks are made thrugh HANC. HANC crdinates the develpment f crss-netwrk CRS requests, submits them t the CRS prject fficer, tracks their prgress, and liaises with DAIDS. Tls n the HANC Prtal streamline CRS Request submissin, tracking and status cmmunicatin. Twenty-tw crss-netwrk CRS requests have been submitted since the CRS cntract was initiated. Details f CRS requests can be viewed at HANC 2019 Wrk Plan 11 f 34 Finalized: December 13, 2018

12 Objectives and Activities by Area f Crdinatin Behaviral Science Crdinatin HANC supprts fur behaviral science grups: Behaviral Science Cnsultative Grup Behaviral Science Wrking Grup Yuth Preventin Research Wrking Grup Behaviral Science Interest Grup Digest Behaviral Science Wrking Grup (BSWG): The Behaviral Science Wrking Grup is a trans-nih Institute and crss-netwrk cmmittee that was frmed as an utcme f the July 2008 HANC and Natinal Institute f Mental Health (NIMH) spnsred Preventin Adherence meeting. The wrking grup is charged with ensuring that the NIH HIV/AIDS Clinical Trials Netwrks benefit frm state-f-the-science methds and prcedures that ptimize adherence t prduct and risk reductin cunseling and minimize the risk f cnfunding user- and prduct failures. Further, the Behaviral Science Wrking Grup endeavrs t maximize fiscal and scientific resurces, reduce redundancies, imprve crss-netwrk cmmunicatin and cllabratin, and ensure that the best quality behaviral science is integrated int clinical trials. The wrking grup, frmed in Q4 f Year 3, hlds mnthly telecnference calls and ad hc tpic-specific calls. Behaviral Science Interest Grup Digest (BSIG): The BSIG was frmed as an utcme f the 2010 BSWG face-t-face meeting. The BSIG s missin is t share state-f-the-science develpments and facilitate discussin amngst netwrk investigatrs, independent behaviral and scial science researchers, cmmunity members, statisticians, and data managers with the gal f enhancing behaviral research within DAIDS clinical trials. HANC maintains a resurce center featuring relevant case reprt frms, articles f interest, white papers, best practices dcuments, funding pprtunities, and meeting presentatins. The ver 375 members receive a weekly digest f new library additins and are encuraged t participate in the BSIG Tpics f Interest webinar series. HANC als maintains a webpage describing hw t prpse a netwrk behaviral studies and data analyses. Behaviral Science Cnsultative Grup (BSCG): The Behaviral Science Cnsultative Grup was frmed after the 2013 BSWG face-t-face meeting. The NIMH prvides resurces thrugh HANC t a grup f within-netwrk and external expert behaviral and scial scientists t assist the netwrks in navigating the cmplex behaviral/bimedical science issues. The BSCG s verarching bjectives are t prvide cnsultatin as requested t the NIH HIV/AIDS Clinical Trials Netwrks n the behaviral cmpnents f their research agenda and studies: including but nt limited t, advice n prtcl design, prtcl implementatin and methdlgy fr data cllectin, and evaluatin. The BSCG has prvided cnsultatin n a variety f prtcls fr all the netwrks since the inceptin f the grup. Yuth Preventin Research Wrking Grup (YPRWG): The crss-netwrk/trans-institute Yuth Preventin Wrking Grup (YPRWG) was frmed in the Q3 f Year 6. Its creatin was a key recmmendatin emerging frm the NIH Fcused initiatives fr Healthier Lifestyles by the Inter Netwrk Advisry Grup n Adlescent Preventin meeting. The grup cnsists f representatives frm the NIH HIV/AIDS Clinical Trials Netwrks, the Adlescent Trials Netwrk (ATN), DAIDS, NIAID, NIMH, NIDA, NICHD, and OAR. The scpe is dmestic and internatinal and fcused n year lds. The members cnduct bimnthly calls and cnvene at netwrk meetings as able. The grup addresses the fllwing: HANC 2019 Wrk Plan 12 f 34 Finalized: December 13, 2018

13 Crdinate sharing f netwrk adlescent research agendas Address the challenge f cnducting trials acrss multiple netwrks Cnsider tangible utcmes such as drpping the mean age f netwrk vlunteers Cmpare nging and upcming studies Cnsider adlescent issues early n in design prcess Review relevant infrmed cnsent dcuments Hst webinars and trainings related t adlescent preventin research Behaviral Science Wrking Grup Crdinatin Objectives fr 2019 Behaviral Science Wrking Grup Objective 1: Imprve infrmatin exchange amng netwrk-affiliated behaviral and scial scientists. Identify and address pprtunities t harmnize behaviral science research and tls acrss netwrk studies. Behaviral Science Wrking Grup Objective 2: HANC will cntinue t manage a Behaviral Science Interest Grup listserv and resurce center whereby researchers can receive updates frm the field, links t influential articles, netwrk study updates, meeting infrmatin, etc. HANC will cntinue t hst a BSIG Tpics f Interest webinar series. Webinar recrdings will be archived n the BSIG Resurce Center. Expand the BSIG Rx Cnnect listserv, allwing members t pse research questins and receive cmments and recmmendatins frm the BSIG research cmmunity. Behaviral Science Wrking Grup Objective 3: Maintain a repsitry f behaviral and adherence measures, data frms (CFRs), and standardized cre elements f interventins accessible t partnering netwrks. The dcuments and links are hused n the HANC public website under Behaviral Science Publicatins and/r the HANC prtal s Behaviral Science Interest Grup Resurce Center. Behaviral Science Wrking Grup Objective 4: Members f the BSWG will reprt back frm plenary sessins at netwrk annual meetings t discuss new develpments and their implicatins fr netwrk science, take stck f lessns frm related dmains, prvide new and nging adherence cunselr training, elicit cmmunity wrking grup input n adherence measurement and cunseling, etc. Behaviral Science Cnsultative Grup Crdinatin Objective fr 2019 Behaviral Science Cnsultative Grup Objective: The BSCG s verarching bjectives are t prvide cnsultatin as requested t the NIH HIV/AIDS Clinical Trials Netwrks n the behaviral and scial science cmpnents f their research agenda and studies: including but nt limited t, advice n prtcl design, prtcl implementatin and methdlgy fr data cllectin, and evaluatin. The BSCG will re-engage intermittently with Netwrk Leadership after the release f the FOA. Onging activities that supprt the abve bjective: The BSCG will cntinue t prvide cnsultatin n behaviral and scial science aspects f the fllwing prtcls An MTN qualitative sub-study f VOICE evaluating rapid feedback frm fcus grups and structured interviews. A subgrup f the BSCG cmpleted a pster fr presentatin in 2017 and the grup has drafted a paper that has been submitted t be published in AIDS and Behavir. Adherence cunseling and assessments fr the PHOENIx study Onging cnsultatin fr the AMP study Onging cnsultatin fr HPTN 083 Other items as Netwrks reach ut t the BSCG fr cnsultatin Face-t-face meeting in 2019 (date has yet t be determined). HANC 2019 Wrk Plan 13 f 34 Finalized: December 13, 2018

14 The BSCG is planning t hst a webinar series in 2019 highlighting the wrk the BSCG has cntributed t Netwrk prtcls. Yuth Preventin Research Wrking Grup Objectives fr 2019: Yuth Preventin Research Wrking Grup Objective #1: Ensure crss-netwrk/trans-institute cmmunicatin arund research in adlescent ppulatins. Wrking grup members accmplish this gal by liaising with their respective netwrk leadership and prtcl team members t share their assessment f nging research initiatives as well as identify ptential gaps in the adlescent research agenda. Yuth Preventin Research Wrking Grup Objective #2: Explre pprtunities t prvide resurces (training materials, webinars, etc.) and expertise t sites cnducting research with adlescents. The YPRWG will hst webinars, sympsiums, and trainings at netwrk meetings and/r cnferences as apprpriate. Materials frm YPRWG hsted webinars, sympsiums, and trainings will be stred n the HANC website in the Yuth Preventin Research Resurce Library t increase visibility f these resurces. Yuth Preventin Research Wrking Grup Objective #3: Explre the develpment f c-endrsed prtcls r adlescent sub-studies. Yuth Preventin Research Wrking Grup Objective #4: Ensure an nging dialgue between wrking grup members and relevant stakehlders thrugh regular review f wrking grup prjects, pririties, and bjectives. Cmmunicatins Wrking Grup The Cmmunicatins Wrking Grup was instituted in June f Since its frmatin, the grup has cnsidered a wide variety f issues affecting netwrk clinical trials. The grup is cmprised f netwrk cmmunicatins prfessinals and cmmunity liaisns. Much attentin has been paid t new media and scial netwrking tls, study results messaging, and understanding the netwrks respective cmmunicatins strategies and plicies. The Cmmunicatins Wrking Grup has bimnthly calls and tpic-specific webinars are scheduled as requested. Cmmunicatins Wrking Grup Objectives fr 2019 Cmmunicatins Objective #1: Review netwrk cmmunicatins effrts and cnsider best practices that culd be emplyed within the netwrks. Share experiences with creative design, advertising, and develpment f materials t aid with participant recruitment fr netwrk studies. Share vide prductin tls and experiences. Share experiences using new technlgies, scial media, and netwrk sites such as Facebk, LinkedIn, and Twitter and track web traffic generated frm new media sites. Share netwrk cmmunicatins strategies, external relatins plicies, and strategies related t study launch, DSMB review, and results disseminatin. Share cmmunity engagement strategies. Cmmunicatins Objective #2: Invite key stakehlders, pinin-makers, and experts in the field t present n wrking grup calls. Areas f expertise culd include: jurnalists, advcates, blggers, and cmmunicatins prfessinals. Cmmunicatins Objective #3: Share messaging strategies arund and leading up t majr studies, particularly fr high prfile studies and multi-netwrk studies. HANC 2019 Wrk Plan 14 f 34 Finalized: December 13, 2018

15 Share and disseminate netwrk submissins t majr cnferences fr HIV/AIDS research. Prvide updates n majr study milestnes that may impact ther studies in the field. Cmmunity Crdinatin Since the late 1990 s, cmmunity representatives assciated with NIH HIV/AIDS Clinical Trials Netwrks and studies have been wrking tgether t identify cmmn issues and t learn new appraches and slutins frm each relating t cmmunity invlvement. A Crss-CAB Wrking Grup (CCWG) was frmed in 2003, and HANC began prviding facilitatin fr their calls shrtly afterwards. In 2005, Crss-Netwrk Best Practices fr engaging cmmunity were develped by a grup f cmmunity representatives and DAIDS. In June 2007 the CCWG was replaced by Cmmunity Partners (CP), an RFA-mandated bdy with a missin t enhance research by maximizing the effectiveness and benefits f cmmunity participatin within and acrss the NIH HIV/AIDS Clinical Trials Netwrks. Cmmunity Partners and Wrking Grups HANC supprts Cmmunity Partners and the tpic-specific wrking grups that it cnvenes. The HANC Cmmunity Partners Prject Crdinatr serves as a nn-vting member f CP and prvides grup facilitatin, prject crdinatin, fiscal versight, and administrative supprt. Cmmunity Partners Executive Cmmittee Cmmunity Training Cmmunity Research Pririties Cmmunity Ethics Cmmunity Partners (CP) is a crss-netwrk bdy charged with prmting effective representatin f the many cmmunities within which the NIH HIV/AIDS Clinical Trials Netwrks cnduct research. CP represents crss-netwrk cmmunity research needs and pririties t netwrk leadership and DAIDS and is a venue fr sharing resurces and experiences acrss the netwrks, aviding duplicative effrts, identifying and addressing challenges t participatin in trials. CP is tasked with ensuring effective netwrk representatin and articulatin f: scientific agenda pririties; ethical cnduct f clinical trials; cmmunity educatin; cmmunicatin and infrmatin disseminatin; respect fr cmmunity pririties; and cntinued cmmunity participatin. CP members are representative f the glbal NIH HIV/AIDS Clinical Trials Netwrks research sites. Map f Cmmunity Partner members lcatins: HANC 2019 Wrk Plan 15 f 34 Finalized: December 13, 2018

16 The Cmmunity Partners Executive Cmmittee is drawn frm the general membership f Cmmunity Partners and is empwered t make decisins n behalf f and in the best interests f CP and its general membership in accrdance with CP Organizatinal Guidelines. The Cmmunity Training Wrking Grup cnsiders areas f cmmunity training cmmn acrss netwrks and standardizes r develps materials that have brad applicatin t cmmunity issues arund HIV/AIDS clinical research and participatin in trials. The Cmmunity Research Pririties Wrking Grup cnsiders areas f cmmunity research pririties acrss netwrks and makes recmmendatins t DAIDS and Netwrk Leadership. The Cmmunity Partners Ethics Wrking Grup slicits input frm netwrks and ther grups t prvide input and recmmendatins t DAIDS and Netwrk Leadership regarding the infrmed cnsent prcess, management f pregnancy and cntraceptin in clinical trials, trial designs relative t guidelines and lcal standards f care, and placeb arms in preventin trials. Cmmunity Crdinatin Objectives fr 2019 Cmmunity Partners Objective #1: Enable invlvement in the develpment and sharing f CP research pririties, and harmnizatin between cmmunity and investigatr research pririties. CP Research Pririties Wrking Grup Wrk directly with DAIDS Crss-Netwrk Transgender wrking grup t prmte the Transgender Training Curriculum fr HIV Research with the Netwrks and ther grups t encurage glbal adptin and implementatin f the recmmendatins. Cntinue t review and make recmmendatins n c-endrsed prtcls t ensure cmmunity input. Wrk with the CP Training WG n updating the Recmmendatins Dcument Wrk with CP Training WG n develping FAQ sheet n Lng-acting injectables and Bradly neutralizing antibdies (bnabs) HANC 2019 Wrk Plan 16 f 34 Finalized: December 13, 2018

17 Review netwrk effrts n the CP pririties and identify pririty gaps in research prir t and after the Leadership RFA and fcus n the fllwing: Cntinue t supprt TB/HIV c-infectin educatin effrts Pediatric and Adlescent issues acrss netwrks Cmmunity Partners Objective #2: Utilize the Cmmunity Training Wrking Grup t identify unmet training needs that are cmmn acrss the netwrks and determine hw they can best be addressed. Examine the Recmmendatins Dcument t determine if and hw it needs t be updated Develp r prmte materials arund hw t review a prtcl Prmte CP Training Materials Netwrk meetings and cnferences Develp FAQ sheets n hw t access resurces and training materials including the DAIDS Learning Management System Develp a multi-netwrk CAB lessns learned/best practices dcument (prtcl review, CAB rientatins, CAB meetings, etc.) Cntinue partnership with CRAG in develping TB/HIV presentatins, materials, best practices Hst webinar arund use f new research language (pen label, superirity/inferirity) t educate cmmunities Partner with ther grups t develp r disseminate materials addressing HIV in the cntext f sexual vilence against girls and wmen Cmmunity Partners Objective #3: CP will cllabrate n the analysis and manuscript f the netwrk-level cmmunity input survey cnducted in Analyze survey data evaluating the impact f netwrk-level cmmunity input Cllabrate with clleagues frm Cncept Systems Inc. in this effrt Submit a manuscript fr publicatin with the netwrk-level cmmunity impact survey data Cmmunity Partners Objective #4: Utilize CP t prvide input and recmmendatins t fcus n meeting the missin f Cmmunity Partners t facilitate and enhance cmmunity representatin and input at all levels in HIV/AIDS and related clinical research within the netwrks. Cmmunity Partners Executive Cmmittee Develp specific strategies and tls t address stigma, including wrking with the TBTC CRAG cmmunity representatives Develp strategies t assist cmmunities t priritize research activities glbally and lcally by means f engagement as needs arise Facilitate and enhance mre effective cllabratin with the Legacy Prject and the WHRC with inclusin f CP membership t these grups Lead r cllabrate n letters f supprt fr internatinal r dmestic advcacy Cntinue t mnitr and prvide supprt t CABs and cmmunities impacted by site clsures r changes in research r prtcls (e.g. Site Clsure Slide Deck) Identify pprtunities fr imprvement and wrk in cllabratin with DAIDS and Netwrk Leadership t ensure disseminatin f research results (NIAID t share press releases with HANC t share with CP, cmmunities and sites) Hst r c-hst cmmunity-fcused wrkshps/presentatins n nging netwrk research and cmmunity engagement activities Hst wrkshps/presentatins at USCA 2019, Unin Cnference Cmmunity Space in Amsterdam in 2019 and ther meetings/events t engage cmmunities and prmte wrk and activities f Cmmunity Partners, including ur cllabratin effrts with TBTC CRAG Develp a White Paper t highlight the cllabratin f CRAG and CP in addressing issues arund TB/HIV cinfectin frm a cmmunity perspective HANC 2019 Wrk Plan 17 f 34 Finalized: December 13, 2018

18 Develp strategies and define scpes t measure cmmunity engagement glbally and lcally frm a cmmunity perspective Using infrmatin frm the HANC mnthly newsletter, pst CP infrmatin in CAB and netwrk newsletters and netwrk public websites (fllw-up n a quarterly basis) Link t CRAG Site and Resurces n CP Site Cmmunity Partners Objective #5: Review tpics acrss netwrks; identify areas where there are prblems r pprtunities fr imprvement and wrk in cllabratin with the Netwrk Leadership and DAIDS t address thse issues. Cmmunity Partners & Cmmunity Ethics Wrking Grup Identify pprtunities fr imprvement and wrk in cllabratin with DAIDS t prvide guidance t researchers, cmmunities and stakehlders regarding the ethical cnsideratins and challenges in research with individuals facing stigma, discriminatin, legal sanctins and/r interpersnal vilence, and scial harms Supprt CABs and cmmunity members wh review prtcls fr stigmatizing language and make language change recmmendatins Cmmunity Partners Objective #6: Utilize CP members t prvide infrmatin exchange t enhance cllabratin and identify further engagement tpics/issues. Cmmunity Partners Frmalize engagement with ATN Yuth CAB Prmte CP training materials at full netwrk grup meetings and ther trainings as requested fr the benefit f cmmunity members and site staff Gather and rganize existing netwrk CAB newsletters t pst n the HANC Website Data Management Center Crdinatin The netwrk Statistical and Data Management Centers (SDMCs) have identified key areas in which the sharing f expertise, resurces, and prcedures will strengthen the capacity and increase the efficiency f data management peratins. The DMC Wrking Grup includes representatives frm FSTRF, SDAC, and SCHARP, and meets n mnthly telecnferences t carry ut activities t address crss-netwrk data management crdinatin bjectives. DMC Wrking Grup Objectives fr 2019 DMC Crdinatin Objective #1: Cnvene mnthly telecnferences t discuss varius nging data quality assurance prjects, identify areas fr imprvement, prvide recmmendatins, and implement new prcesses and prcedures as apprpriate. Slicit agenda items frm the DMCWG fr the mnthly DAIDS-ES All Cllabratrs call. Mnitr crss-dmc standardizatin supprt needs fr AE/EAE recnciliatin. Strategies t supprt this include: wrking with DAIDS t identify data elements that are required t be recnciled, maintain nging dialgue with DAIDS staff regarding challenges encuntered with recnciliatin. Liaise with NIAID CRMS team t identify areas fr cllabratin and enhanced data sharing acrss NIAID CRMS and the SDMCs. Share CDISC implementatin activities acrss DMCs; e.g., regularly check in with CDISC cnsultant, assist in crdinatin, and discuss develpments acrss the netwrks. HANC 2019 Wrk Plan 18 f 34 Finalized: December 13, 2018

19 DMC Crdinatin Objective #2: Wrk with apprpriate regulatry grups t assist in the develpment f prcedures and prcesses related t electrnic data capture (EDC), electrnic signatures, prtcl deviatin reprting, etc. Share develpments in these prcedures and prcesses acrss netwrks and data management centers. Disperse infrmatin n EDC t netwrks and sites fr new and transitining studies. Liaise with netwrk perfrmance/evaluatin cmmittees and OCSO t adapt new plicies and prcedures as apprpriate fr the transitin t EDC as it impacts site perfrmance evaluatin metrics and site mnitring prcedures. Liaise with relevant crss-netwrk wrking grups t slicit site-level and ther apprpriate feedback n prcesses and plicies invlving the data management centers. Liaise with OPCRO and OSCO t prvide feedback n prpsed plicies and prcedures. DMC Crdinatin Objective #3: Wrk with HANC t prvide brad access t DMC-related nline training resurces n tpics such as the DAIDS Txicity Table and Electrnic Data Capture (EDC) systems. Select apprpriate training resurces fr cnslidatin in the HANC training library, wrking with ther grups t ensure relevant and brad selectin f apprpriate training materials. Publicize training pprtunities by reaching ut t netwrk DMCs and ther netwrk members thrugh HANC and ther means as apprpriate. Respnd t requests fr training materials, update training tpics when apprpriate, and mnitr resurce usage via HANC staff. Evaluatin Crdinatin Evaluatin Cmmittee The Evaluatin Cmmittee discusses and prvides a frum t share netwrk appraches t evaluatin, including the site evaluatin prcesses. The Cmmittee cnsists f representatives frm each Netwrk Evaluatin Cmmittee and additinal Netwrk Evaluatin Cmmittee members as determined by the netwrk. Evaluatin Wrking Grup Objectives fr 2019 Evaluatin Objective #1: Discuss pprtunities t harmnize timelines and frmats f evaluatin reprts acrss the netwrks. Mnthly-bimnthly crss-netwrk evaluatin telecnferences will prvide a frum t discuss and address pprtunities. Onging discussins n the revisins t the netwrk evaluatins prcesses and setting site perfrmance criteria and expectatins. Share experiences arund sftware prgrams fr real-time reprting f evaluatin metrics. Evaluatin Objective #2: Discuss pprtunities t harmnize the definitin, calculatin, and implementatin f site evaluatin metrics related t data management. Cntinue cllabratin with DMC staff t harmnize hw metrics related t data management are calculated using data frm Medidata Rave. Onging discussins with evaluatin staff n the implementatin f these metrics as part f the site evaluatin prcess. HANC 2019 Wrk Plan 19 f 34 Finalized: December 13, 2018

20 Evaluatin Objective #3: Share appraches t reprting prtcl deviatins as part f site evaluatin reprts. Track develpments in DAIDS plicies related t prtcl deviatin reprting. Onging discussin n netwrk appraches t and utility f reprting prtcl deviatins as part f the site evaluatin prcess. Evaluatin Objective #4: Harmnize the cmmunity indicatr survey fr evaluatin f cmmunity engagement. Review and update the cmmunity indicatr survey library. Cllabrate with evaluatin staff t identify areas f verlap in survey cntent and pprtunities t streamline delivery f the cmmunity indicatr survey. Financial Disclsure Database Financial Disclsure Database Objective: Wrk clsely with netwrk staff and DAIDS t peridically review the harmnized netwrk financial disclsure requirements and maintain the crss-netwrk web-based reprting interface develped in Cntinue t review U.S. Health and Human Services financial disclsure regulatins and audit requirements. Cntinue t clarify with DAIDS, sites, and prduct spnsrs FDA-specific financial disclsure requirements and SOPs. Cnsult netwrk grantee institutins n matters f financial disclsure requirements, prcesses, and reprting. Update and imprve nline reprting system functinality. Crdinate investigatr lists acrss the NIH HIV/AIDS Clinical Trial Netwrks and PHACS. Labratry Crdinatin Labratry Cmmittees and Wrking Grups The Lab Fcus Grup: The Lab Fcus Grup (LFG) is cmprised f Netwrk Labratry Leadership and management staff. It hlds telecnferences mnthly t versee all crss-netwrk labratry activities, including plicy and prcess develpment and fllw-up wrk t cmplete crss-netwrk prjects and tasks that address labratry training, peratins, and supprt issues. The telecnferences prvide a frum fr identifying, discussing and reslving issues, sharing infrmatin, and identifying new prjects and tasks t be included in crss-netwrk labratry crdinatin effrts. LFG Objectives: 1. Cntinue t identify labratry issues that require input frm all the netwrks, in cllabratin with DAIDS Clinical Labratry Oversight Team (DCLOT), t assure that netwrk labs are implementing quality and efficient lab prcesses. 2. Cntinue t identify where ecnmies f scale can be achieved by sharing resurces, shared pricing agreements, technician training pprtunities, labratries, etc. and address these pprtunities in existing r new wrking grups as necessary. a. Cntinue t mnitr reagents r materials fr pssible issues that may affect multi-netwrks 3. Cntinue t identify and address pprtunities t harmnize labratry prcesses and prcedures t reduce redundancy, increase efficiency and clarify expectatins, especially at shared site labratries. a. Review the Crss-Netwrk Guidelines fr Diagnsis f HIV infectin in general terms and revise as needed t reflect any changes per netwrk. HANC 2019 Wrk Plan 20 f 34 Finalized: December 13, 2018

21 4. Cntinue t identify areas in lab peratins and prcesses t incrprate principles f GCLP and ensure that data generated are f the highest quality, including but nt limited t timeliness, accuracy, and clinical apprpriateness. GCLP guidelines will be reviewed n an annual basis. PBMC SOP Wrking Grup: The PBMC SOP Wrking Grup is charged with develping, publishing and reviewing the Crss-Netwrk PBMC Prcessing SOP fr all netwrk-affiliated labs that prcess PBMC. The SOP is reviewed and updated by the PBMC Wrking Grup n a biannual basis. The Crss Netwrk Cld Chain Guidelines Wrking Grup: The Crss Netwrk Cld Chain Guidelines Wrking (CCGWG) grup is charged with maintaining guidelines fr utilizing and maintaining ptimal cld chain temperature f specimens during the retrieval prcess within the labratry r upn shipment t an external labratry/repsitry. The SOP is reviewed and updated by the CCGWG at the directin f the LFG. The ACTG/IMPAACT Labratry Technlgist Cmmittee: The ACTG/IMPAACT Labratry Technlgist Cmmittee (LTC) is a jint ACTG/IMPAACT cmmittee. Vting and nnvting prtcl supprt members serve n prtcl teams and prvide technical expertise in the develpment f the labratry cmpnents f prtcls as well as standardizing the handling, prcessing, labeling, strage and shipping f clinical specimens acrss all ACTG/IMPAACT clinical sites and labratries. HANC supprt staff crdinates specific prjects and give technical supprt t the cmmittee and maintains the cmmittee s site n the HANC prtal. HANC supprt staff als helps t track LTC member wrklads, helps t maintain existing dcuments and develp new dcuments stred in the resurce dcument libraries, and maintains a discussin bard t facilitate cmmunicatin acrss the members f the cmmittee. Several ther resurces, including the ACTG/IMPAACT Labratry Manual, are psted n the HANC public website, and HANC supprt staff helps t facilitate the review f new and updated SOPs and prvide standardizatin f templates and frmatting. HANC als maintains regularly updated vendr pricing, rdering details, and prduct infrmatin fr Fetal Bvine Serum fr ACTG and IMPAACT labratries n the HANC webpage. The LTC hlds telecnferences twice per mnth, and HANC supprt staff attends the calls, recrds them, and psts cmmittee-apprved minutes n the HANC website. LTC Objectives: 1. Prmting unifrm handling, prcessing, labeling, strage, and tracking f specimens (accrding t cnsensus prcedures) acrss all clinical sites and labratries; maintaining a regularly updated labratry manual f cnsensus prcedures readily available fr access by all ACTG/IMPAACT labratries. a. HANC prvides a frum t share technical expertise and reslve labratry issues including but nt limited t assay/prcessing prcedures, LDMS use, and labratry peratins. Tpics may als include discussins n prtcl cmplexity as well as upcming nvel/esteric assays. b. HANC supprt staff helps t facilitate the regular review and update f labratry standard perating prcedures (SOP) and maintains the dcument cntrl prcesses. c. HANC supprt staff helps t facilitate the regular update and maintenance f Standardized Wrding dcuments fr use in develping LPCs, and maintains ther dcuments, such as the LPC templates and the budget cst list used by the LTC fr creating prcessing budgets fr ACTG clinical trials. 2. Serving as a resurce t the NIAID/Divisin f AIDS, Statistical and Data Analysis Center, Data Management Center, Operatins Center, and Clinical Site Mnitring Grup; acting as a liaisn between site persnnel, labratries, clinics and the leadership f the ACTG/IMPAACT and its cntractrs as well as facilitating cmmunicatin and netwrking amng the labratries, clinics and Data Management Center HANC 2019 Wrk Plan 21 f 34 Finalized: December 13, 2018

22 a. HANC serves as a resurce fr facilitating cmmunicatin between the LTC and ther the NIAID/ Divisin f AIDS, Statistical and Data Analysis Center, Data Management Center, Operatins Center, and Clinical Site members. 3. Prviding infrmatin and educatin fr labratry persnnel in the areas f prtcl implementatin, cllectin and regular exprt f quality data, regulatry requirements, new prcedures and plicies; a. HANC supprt staff helps the LTC members train new members by facilitating the creatin f training packets, ffering training webinars, and maintaining supprt dcuments n the HANC website. EQA Prvider Wrking Grups: The EQA Prvider Wrking Grups ensure standard quality assurance fr all the prtcl-specified assays cnducted in DAIDS-spnsred netwrk clinical trials acrss netwrks and ther partners thrugh the Ttal Quality Management (TQM) Prgram. The TQM Prgram imprves the transparency and respnsiveness f decisin-making regarding results f prficiency testing at DAIDS- funded site labratries by imprving cmmunicatin and timely access t relevant infrmatin. 1. The crss-netwrk QA wrking grups including the CPQA grups and VQAAB will cntinue t prvide a frum fr the review and discussin f prgram-specific prficiency testing results and ther questins that affect external quality assurance n regular telecnference calls. 2. Crss-netwrk QA wrking grups and the LFG (fr patient safety QA) will develp, review, and/r mdify as needed standard perating prcedures fr the mnitring f external quality assurance and investigatin and reprting f rt cause and crrective actin. 3. HANC staff prvides the fllwing in supprt f the CPQA: a. Participate in Steering Cmmittee t assure synchrnus activities amng stakehlders b. Prvides virtual cmmunicatin platfrm fr CPQA grups, including ad hc calls fr leadership and/r cllabratrs i. Plls fr calls as needed ii. Sends ut call annuncements with agenda and materials iii. Sends call reminders and reprts back t CPQA n regrets respnses iv. Prvides draft minutes t CPQA grups fr edits and apprval v. Sends ut final call minutes t respective CPQA grups c. Prvides sftware and dcument develpment supprt; prvides a website area fr maintaining CPQA grup dcuments, agendas and minutes. d. Psts any webinar presentatins with permissin frm speaker(s) The Clinical Pharmaclgy Quality Assurance (CPQA) Advisry Bard: The Leadership f the CPQA Advisry Bard (AB) is cmpsed f a balance f leadership members frm DAIDS funded research and labratry netwrks, the cmmunity f established HIV investigatrs, the cntract spnsr, and CPQA. T implement the functins f the CPQA, the AB may frm such cmmittees, subcmmittees, wrking grups, and external advisry bards as are necessary t carry ut the missin f the CPQA. The Advisry Bard prvides the fllwing: 1. Cmmunicatin regarding scientific and regulatry changes and develpments that are likely t influence the peratin f the CPQA. HANC 2019 Wrk Plan 22 f 34 Finalized: December 13, 2018