1. HPTN 073: Successful Engagement of Black MSM into a Culturally Relevant Clinical Trial for PrEP Christopher Hucks-Ortiz, MPH on behalf of the HPTN Protocol Team and Black Caucus 2016 International AIDS Conference Durban, South Africa 20 July 2016

2. The US sees approximately 50,000 new HIV infections annually Black men who have sex with men (BMSM) are disproportionately impacted Tailored models and approaches that address structural factors and social determinants of health are integral to impacting populations at greatest risk Context of our US Domestic Epidemic

3. Background BMSM remain at disproportionate risk of HIV acquisition Comprise less than 0.4% of the U.S. population, but account for more than 20% of all new infections in 2013 Identifying effective and innovative methods to deliver effective prevention and halt the epidemic is an urgent public health priority HPTN 073 is one of the first studies to evaluate pre-exposure prophylaxis (PrEP) in a US BMSM population

4. HPTN 073 Study Design Demonstration project –3 sites in the United States (Washington, D.C., Los Angeles, CA and Chapel Hill, N.C.) 334 HIV uninfected BMSM screened 226 HIV uninfected BMSM enrolled Offered once daily oral Truvada® as PrEP Client-centered care coordination (C4): individualized prevention counseling, support, and service coordination Participants followed for a total of 12 months

5. Community Engagement Strategies Cultural Responsiveness Training –“A Place At the Table” Training Culturally responsive Recruitment and Retention Strategies –Community Engagement Work Plans (CEWPs) Regular/Ongoing involvement of Local Community Advisory Board Regular/Ongoing consultation with HPTN Black Caucus –Monthly conference call –Biannual Face to Face meeting

6. Specific deliverables that were developed with significant involvement of community members at ALL levels: Local stakeholders and CAB members National stakeholders HPTN Black Caucus Products included: Introductory video Recruitment materials Retention Strategies https://www.hptn.org/resea rch/studies/136 https://www.hptn.org/resea rch/studies/136

7. Demographics of participants enrolled in the study by PrEP Initiation DemographicsOverall NOn PrEPNot on PrEP Site22679%21% Age <259184%16% ≥2513576%24% Gay16681%19% Bi-sexual4571%29% Marital Status Primary or main partner Male7478%22% Female 3 100%- Transgender --- Ethnicity African-American/Black/Caribbean20478%22% Afro-Latino 17 82% 18% Other 580% 20%

8. Demographics of participants enrolled in the study by PrEP Initiation DemographicsOverall NOn PrEPNot on PrEP Site22679%21% Healthcare Coverage15577%23% Incarceration6974%26% Highest education level attained High School or less5677%23% Some college/vocational school9377%23% 2yr/4yr or greater7782%18% Annual income (decline to answer 1%) <20k 10874% 26% 20k – 49k 6481% 19% ≥50k 5184% 16% Declined to answer Employment Status Unemployed/disability/other6166%34% Employed part-time/self-employed8084%16% Employed full-time8584%16%

9. HPTN073 demonstrated that BMSM can be successfully recruited, engaged, and retained in PrEP biomedical clinical trials using theory- based culturally tailored techniques. The study provides a model for how best to integrate culturally-specific recruitment approaches when targeting communities at risk for HIV acquisition. Utilizing theory-based culturally tailored programs for BMSM that are reflective of their reality is key to reaching highly at risk populations of MSM who can benefit from new biomedical HIV prevention advances. Conclusions

11. Acknowledgements The HIV Prevention Trials Network is sponsored by the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, and the National Institute on Drug Abuse, all components of the U.S. National Institutes of Health.

12. Acknowledgements Protocol Co-Chairs Dr. Darryl Wheeler Dr. Sheldon Fields HPTN 073 Study Protocol Team HPTN Leadership HPTN Black Caucus Gilead Sciences Study Participants