Correlates of HIV incidence among black men who have sex with men in 6 U.S. cities (HPTN 061)

1. Correlates of HIV incidence among black men who have sex with men in 6 U.S. cities (HPTN 061) B. koblin, K. Mayer, S. Eshleman, L. wang, s. shoptaw, c. del rio, s. buchbinder, m. magnus, s. mannheimer, t-y liu, v. cummings, e. piwowar-manning, s. fields, s. griffith, v. elharrar, d. wheeler For the HPTN 061 team

2. HIV in the US • MSM comprise the single largest group of individuals in the US who have become infected with HIV • In 2010, 61% of new HIV infections occurred among MSM. • Black MSM are greatly disproportionately affected • 37% of new HIV infections among MSM occurred among black MSM

3. HPTN 061 Methods • Longitudinal study designed to determine the feasibility and acceptability of a multi-component intervention for black MSM (7/2009-12/2011) • Components included: HIV and STI counseling, testing and referral for treatment; counseling and referral for care for issues such as substance use and mental health; peer health navigation; and referral of sexual network members. • Study sites: • Atlanta, Boston, Los Angeles, New York City, San Francisco and Washington DC. • Recruitment from the community or sexual partners referred by men enrolled in the study (7/2009-10/2010)

4. HPTN 061 Methods • Eligibility Criteria • Age >18 years • Self-identify as a man, or male at birth • Self-identify as Black, African American, Caribbean Black or multi-ethnic Black; • Unprotected anal intercourse with a man in last 6 months

5. HPTN 061 Methods • Both HIV-uninfected and HIV-infected men were enrolled • HIV-uninfected at enrollment • Newly diagnosed at enrollment • Prior HIV diagnosis, but not engaged in care and/or having unprotected sex with partners who were uninfected or of unknown status • Prior HIV diagnosis and in care or having sex with only HIV-infected men (up to 10 per site)

6. HPTN 061 Methods • Baseline visit: • Consent, locator information • Demographics • Self-administered behavioral assessment using computer • Behaviors in prior 6 months • Interviewer-administered social and sexual network inventory • Counseling and HIV rapid test, urine and rectal swabs for Neisseria gonorrhoeaeand Chlamydia trachomatis, syphilis testing • Offered peer health navigation to link clinical and social services, as needed • All participants testing positive for any infection were linked to treatment and medical care services • Follow-up visits: 6 and 12 months

7. HPTN 061 Methods • HIV infections • Based on real-time testing at study sites • All HIV infections confirmed by the HPTN Network Laboratory (NL) • HIV incidence • Calculated as number of new infections/person-years of follow-up • Confidence intervals calculated using exact methods

8. Study population • 1,553 men were enrolled • 174 reported a prior HIV diagnosis • 1,379 without a prior HIV diagnosis • 46 refused testing and/or a baseline specimen was not available for confirmatory testing at the HPTN NL • 165 (12.4%) were newly diagnosed, including 3 with acute infection (identified by the HPTN NL) • 1,168 uninfected at baseline • 1,009 tested for HIV during study follow-up

9. Retention • Endpoint retention: • 87% at 6 mos • 79% at 12 mos • No significant differences between retained and not retained • Demographics, baseline risk behaviors and STIs

10. Study population (n=1,009)

11. Study population (n=1,009) * Any mention from multiple options

12. Study population (n=1,009)

13. HIV incidence by subgroups

14. HIV incidence by subgroups

15. HIV incidence by subgroups * All other categories besides gay or homosexual

16. HIV incidence by subgroups

17. HIV incidence by subgroups

18. HIV incidence by subgroups

19. Summary and conclusions • In the largest prospective cohort of black MSM in the US, HIV incidence was high, particularly among • Young men • Those reporting unprotected receptive anal intercourse • Gay/homosexual self-identified and those with male partners only • Those with STIs diagnosed at baseline • This direct measurement of HIV incidence reinforces concerns about HIV among black MSM

20. Future analyses and conclusions • Additional analyses will be conducted to: • assess changes in behaviors during follow-up and within higher incidence subgroups • examine uptake of peer health navigation during the study • and relationship of these and other variables to HIV incidence • Targeted, tailored and culturally appropriate combination HIV prevention strategies (behavioral, social, structural and biomedical) are urgently needed

21. HPTN 061 Acknowledgements • National Institutes of Health: NIAID, NIDA, NIMH • Protocol Co-Chairs: • Beryl Koblin, PhD • Kenneth Mayer, MD • Darrell Wheeler, PhD, MPH • HPTN 061 Protocol Team Members • HPTN 061 Study Participants • HPTN Network Laboratory, Johns Hopkins Univ. School of Medicine • Statistical and Data Management Center, SCHARP • HPTN CORE Operating Center, FHI 360 • Black Gay Research Group • HPTN Black Caucus Clinical Research Sites, Staff and CABs • Emory University • Fenway Institute • George Washington University School of Public Health and Health Services • Harlem Prevention Center • New York Blood Center • San Francisco Department of Public Health • University of California, Los Angeles Sponsored by NIAID, NIDA, NIMH under Cooperative Agreement # UM1 AI068619 and UM1-AI068613