Game-Changing Community Engagement in HIV Prevention Trials: The AMP Studies

1. The Game-Changing Nature of Early and Ongoing Community Engagement in HIV Prevention Efficacy Trials: The AMP Studies’ Experience (HVTN 704/HPTN 085 & HVTN 703/HPTN 081) Michele Andrasik, PhD Director, Social & Behavioral Sciences and Community Engagement HIV Vaccine Trials Network (HVTN)

2. Perceived Community Engagement Challenges for the AMP studies • Novel approach: 1st efficacy trials of broadly neutralizing antibody (bnAb) for HIV prevention • Infusions – a departure from standard vaccine injections • 10 bimonthly intravenous infusions per participant • 2 years of monthly visits • Recruitment and retention considered major potential barriers

3. The Importance of Community Stakeholder Engagement • Facilitates community awareness, understanding and support for research • Important throughout process – from conceptualization through retention • Critical for effective stigma reduction • Address misconceptions, misinformation and myths • Relationship building and maintenance

4. Comprehensive Community Engagement Approach • Community Consultations • Established Community Working Groups • Ongoing communication with studies’ Community Working Groups • Community-Based Participatory Research (CBPR) approach to materials development • Geographically specific materials and websites • Retention Workshops • Cultural Responsiveness Training

5. Community Consultations • 4 two-day meetings in South Africa with a total of 350 participants • 1 two-day meeting in Boston • 3 one and one half-day Community Educators Trainings (Washington, DC (for US sites); Atlanta (Americas); Washington, DC (South America) • Areas of focus: • HIV prevention tool box and the need for additional tools • The science and study design of AMP • Anticipated implementation challenges and possible solutions • Strategies for ongoing engagement

6. Community Working Groups • Goals/Objectives: • Enhance community engagement strategies and identify possible challenges • Develop Community Engagement workplans prior to study activation • Assist in development of study-specific educational tool kit and communication plans • Share best practices • Conduct community preparedness and ongoing involvement activities • Inform community members of protocol updates and site-specific activities

7. CBPR Approach to Materials Development • Reaching out to community leaders, Clinical Research Site (CRS) staff and protocol team • 4 Videos • Video 1: HIV Prevention and the AMP Study • Video 2: bnAbs • Video 3: HIV and the Prevention Landscape • Video 4: The Importance of Prevention Research: The AMP Study • Identifying stages for community input • Script Development (4 scripts) • Screenplay Development (“storyboards”) • Draft Animations (“Animatics”) • Voice-overs • Background Music • Final Review • Developing methods for Community Input and Guidance at each stage

8. Geographically specific materials and websites

9. Print Materials • Study Brochure, post card & palm card – developed content and reviewed with the Community Working Group, approved by Protocol Team • Identified need for more broadly representative photos • sourced better stock images of African women, including rural settings and multiple races/ethnicities • conducted photo shoots in Seattle, Atlanta, Rochester, and Rio de Janeiro to better reflect transgender people and people of color • Created Image Libraries for each trial so sites can customize

10. Study Websites • Developed content and reviewed with the Community Working Group, approved by the Protocol Team • Made “Contact Us” prominent on all pages for US and Brazil websites • Per CER requests, Peru and sub-Saharan Africa websites are all educational in nature (no contact form) • Included antibody animation and volunteer testimonials, added animated videos once completed • Websites available in 13 languages total

11. Study Websites www.AMPStudy.org (US & Peru) www.AMPStudy.org.za (Africa) www.AMPStudy.org.br (Brazil)

12. Retention Workshops • 2 conducted in Johannesburg and Washington, DC • CRSs identified current and anticipated retention challenges • Shared retention strategies across CRSs • Communication exercises to build capacity for improved retention data collection • Reviewed and revised CRS’s retention plans

13. Cultural Responsiveness Training • Utilized HPTN Black Caucus’ “Presence at the Table” training for Black MSM communities • Worked with subject matter experts to add content for Transgender communities • Training facilitated for US sites • 170 CRS staff attended

14. Strength of Relationships “I felt that it wasn’t about me just coming in here, giving blood and going about my way. It was more about getting to know me and getting to know more about me and everything beyond – not just about the study, but even beyond that, about my school and everything else I got going on in my life.” “…it boils down to the fact that there's a phenomenal group of people that are participating in this. And [site staff] and I have been through a lot, and I wouldn't want to back out on her at the last minute. Obviously, she'd understand if I did, but where – I don't know. Like I just – that's not an option – at least, for me.” “The study staff that I interacted with I began to develop personal relationships with. Everyone was super-friendly. I wanted to continue going.” They were very proactive about making sure I was otherwise healthy outside of the program.

15. Strength of Relationships “Everybody here cares for us, wants us to be healthy, wants us – and wants us to thrive… I believe that you believe in us.” “…because of [CRS staff] personalities, they are accommodating, they are friendly, they kind of made you want to stay because if you just decided to leave, you’re like, “Damn, I don’t want to screw them over. They were so nice to me.” “It’s actually something I look forward to coming to just because I enjoy the people. I enjoy the standard of care that I get lying here. I was not just a number. I wasn’t JUST a participant. I was like, hey, how’s it going? How’s your life?” “The staff has been great with their holistic approach to care. There was also no shaming around sexual activity, and I always felt completely at ease disclosing what I’ve been up to.”

16. Recruitment and Retention Outcomes • Efficient Recruitment: • Average Screening to Enrollment ratios • Americas and Switzerland: 2.8:1 • Sub-Saharan Africa: 2.4:1 • Great Retention: (12 July 2019) • Americas and Switzerland: 95% (range: 92% - 98%) • Sub-Saharan Africa: 96% (range: 92% - 99%) • Overall Early Termination: 8% • Other Contributing Factors • Rapid Process Improvement • Ongoing Community Engagement capacity building • Community excitement resulting from novel approach = HOPE

17. Acknowledgements • Funding for the AMP Studies is provided by the US National Institute of Allergy and Infectious Diseases, Division of AIDS

18. AMP Studies Protocol Team Acknowledgements Chairs • Larry Corey • Myron Cohen Co-chairs • Srilatha Edupuganti • Nyaradzo Mgodi Protocol Team Leader • Shelly Karuna Statisticians • Allan DeCamp • Peter Gilbert • Michal Juraska • Deborah Donnell DAIDS Medical Officers • Margarita Gomez Lorenzo • David Burns Laboratory Lead • John Hural Bioethics Consultant • Mark Barnes CAB Members • Jim Wick • LikhaphaFaku • Mark Hubbard Community Educators • DaShawn Usher • Luciana Kamel Community Program Representatives • Gail Broder • Jonathan Lucas • Jontraye Davis Clinic Coordinators • Ana Patricia Rimachi • Christie Heiberg • Debora Dunbar Consultative Investigators • Ken Mayer • LaRon Nelson • Erica Lazarus Clinical Safety Specialist • Maija Anderson Clinical Trial/Research Mgr • Carissa Karg • Elizabeth Greene • Philip Andrew • India Tindale Data Management • Gina Escamilla • Lynda Emel Developer Representatives • Barney Graham, VRC • John Mascola, VRC • Julie Ledgerwood, VRC Technical Editor • Erik Schwab Lab Representatives • David Montefiori • Estelle Piwowar-Manning • On Ho • Robert Coombs • Susan Eshleman • Vanessa Cummings HPTN LOC Director • NirupamaSista Protocol Development Mgr • Carter Bentley Pharmacist • Katherine Shin Regional Medical Liaisons • Robert De La Grecca • Simba Takuva Regulatory Affairs • Megan Brandon Social Behavioral Scientist • Michele Andrasik Statistics • Abby Isaacs • NidhiKochar

19. HVTN 703/HPTN 081 Site Acknowledgements Blantyre • Annie Munthali, Clinic Manager • Dr. Johnstone Kumwenda, IoR • Dr. YamikaniMbilizi, Study Coordinator Cape Town - Groote Schuur • Amelia  Mfiki, CER • Bianka  Van der Westhuizen, Clinic Coordinator • Catherine  Orrell, IoR Durban - Botha’s Hill • Thank you to all the study site investigators, clinic coordinators, CER teams, and site pharmacists. Durban - Chatsworth • Thank you to all the study site investigators, clinic coordinators, CER teams, and site pharmacists. Durban - eThekwini • Ivy Kaunda, CER • Kathy Mngadi, IoR • Yajna Duki, Clinic Coordinator Gaborone • Emily Makunike, Clinic Coordinator • Ernest Moseki, Community Educator/Recruiter • Joseph M. Makhema, IoR • MuchanetaBhondai, Study Physician Harare - Parirenyatwa • Elizabeth Magada , CER • James Gita Hakim, Site Leader • Lucia Chirongoma , Clinic Coordinator • Pamela Grace Marimbe-Nyatsambo, IoR Harare - Seke South • Constance Murandu, CER • Portia  Hunidzarira, IoR • Thandiwe HildahChirenda, Clinic Coordinator Harare - Spilhaus • Catherine Chitsinde, Clinic Coordinator • Shorai Mukaka, IoR • TarisaiMurefu, Community Educator/Recruiter Johannesburg - WRHI • Dr. Admire Chikandiwa, Clinic Coordinator • Prof. Sinead Delany-Moretlwe, IoR • Sarah  Cohen, Research Operations  Manager Kisumu • David Schnabel, IoR • Dismas Oketch, Study Coordinator • Grace Mboya, Clinic Coordinator/Medical Officer • PhilisterMadiega, CER Klerksdorp • Thank you to all the study site investigators, clinic coordinators, CER teams, and site pharmacists. Lilongwe • Bertha Maseko, Clinic Coordinator • Mina Hosseinipour, IoR • Pearson M’modzi, CER • NelecyChome, CER Mamelodi • Anika Naidoo, Clinic Coordinator • Annah Pitsi, IoR • Annalie Brits, Site Manager • Lucky Molefe, CER Maputo • CarméliaMassingue, CER  • Ilesh Jani, PI • OdeteBule, Clinic Coordinator • Patrícia Ramgi, IoR Mbeya • Doreen Pamba, Community Educator/Recruiter • Emmanuel Kapesa, Clinic Coordinator • Faith Mlagalila, Research Physician • Lucas Maganga, IoR Rustenburg • Thank you to all the study site investigators, clinic coordinators, CER teams, and site pharmacists. Soweto - Bara • Celokuhle Tshabalala, CER • Kishendree Naicker , IoR • Rebecca Phofa , Team Coordinator • Sinovuyo Zepe, Clinic Coordinator Tembisa • Gladys Kobane, Clinic Coordinator • Madulakgotla Sebe, IoR • MotheiMolete, Study Coordinator • ZitheloZikalala, CER Vulindlela • Franco Musiello, Study Coordinator • Halima Dawood, IoR • MzamoMdube, CER  (and Community Team) Thank you to the study participantsandCABandcommunity members!

20. HVTN 704/HPTN 085 Site Acknowledgements… Atlanta - Hope Clinic • April Ross, CER • Javani Williams, CER • Machel Hunt, CER • Rameses Fredrick, CER • Shashi Nagar, Clinic Coordinator • Srilatha Edupuganti, IoR Atlanta - Ponce de Leon • Carlos del Rio, IoR • Edwin Worthington-Blount, CER • Rotrease Regan, Clinical Nurse Coordinator Birmingham • Pamela Cunningham, Clinic Coordinator • Paul Goepfert, IoR • Santorra King, CER • Andrew Yousef, CER Boston - Brigham • Lindsey Baden, IoR • Elvin Fontana-Martinez, CER Boston - Fenway • Dwayne Steward, Community Educator • Kathleen Bailey, Recruiter • Doug Krakower, Sub-Investigator • Kenneth Mayer, IoR • Rossi Fish, Clinic Coordinator Chapel Hill • Cindy Gay, IoR • Gabrielle Evans , CER • Kristen Hancock , Clinic Coordinator • Noshima Darden-Tabb, Community Engagement Manager Cleveland • Benigno Rodriguez, IoR • Brooke Willis, CER • Jane Baum, Clinic Coordinator • Michael Morgan, CER • Robert Bucklew, CER Iquitos • Alberto Quino, Clinic Coordinator • Juan Hinojosa, IoR • Lucia Ruiz, CER • Martin Casapia, Site Leader Lausanne • Christophe Picard, CER • Giuseppe Pantaleo, IoR • Julien Mermoud, CER • Sandra Bettinelli-Riccardi, Clinic Coordinator Lima - Barranco • Javier R. Lama, IoR • María del Rosario Leon, CER • María del Rosario Fernandez-Maldonado, ClinicCoordinator Lima - San Marcos • Jorge Sanchez, IoR • Hugo Sanchez, CER • Daniel Alva, CER • Fanny Rosas, CRS Coordinator Lima - San Miguel • Carla Porcile, CRS Coordinator • Milagros Sabaduche, Clinic Coordinator • Pedro Gonzales, IoR • Yamir Salazar, CER Lima - Via Libre • Consuelo Tristan , Clinic Coordinator • Jose Luis Castro, CER • Robinson Cabello, IoR Los Angeles - Vine Street • Christopher Blades, CER • Jesse  Clark, IoR • Maureen Garcia, Clinic Coordinator • Schuyler Thomas, CER • Susan Reed, Research Nurse Coordinator Nashville • Spyros Kalams, IoR • Kyle Rybczyk, Clinic Coordinator • Vic Sorrell, CER New Jersey • Christie Lyn Costanza, CER • RondalyaDeShields, Clinic Coordinator • Shobha Swaminathan, IoR • Travis Love, Recruiter

21. …HVTN 704/HPTN 085 Site Acknowledgements New York - Bronx Prevention • JawindySwengbe, CER • Jessica Justman, IoR • Kevin Mines, CER • Rita Sondengam, Clinic Coordinator New York - Harlem Prevention • Jaron Cook , CER • Jessica Justman, IoR • Jun Loquere , Clinic Coordinator New York - NYBC • DaShawn Usher, CER • Debbie Lucy, Clinic Coordinator • Eddie Bravo, CER • Hong Van Tieu, IoR • London Miles, CER New York - Physicians & Surgeons • Brett Gray, Research Clinician • Jorge Benitez, CER • Jackie Wu, CER • Henry Peralta, CER • Magda Sobieszczyk , IoR • Steven Palmer, Clinic Coordinator Philadelphia • Annet Davis, CER • Deb Dunbar, Clinic Coordinator • Ian Frank, IoR Rio de Janiero • Brenda  Hoagland, Clinic Coordinator • Larissa Villela, Investigator • Luciana Kamel, CER • ValdiléaVeloso, IoR Rochester • Mike Keefer, IoR • Cathy Bunce, Clinic Coordinator • Cody Gardner, CER • Andrew Moran, CER San Francisco • Josephine Ayankoya, Community Programs Manager • Susan Buchbinder, IoR • Theresa Wagner, Clinic Coordinator Seattle • David Berger, Clinic Coordinator • Julie McElrath, IoR • Kim Louis, CER • Janine Maenza, Co-Investigator Washington, DC • Alexander King, CER • AurnellDright, CER • Manya Magnus, IoR/PI/CRS Leader • Marc Siegel, Study Physician/Co-PI • Vivi Mani, CER/RA Thank you to the study participantsandCAB andcommunity members!