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. 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 HIV in the US

3. 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) HPTN 061 Methods

4. 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 HPTN 061 Methods

5. 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) HPTN 061 Methods

6. 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 gonorrhoeae and 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 HPTN 061 Methods

7. 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 HPTN 061 Methods

8. 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 Study population

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

10. Study population (n=1,009) Baseline characteristic No.% < 30 yrs old38038 Some college education or more46646 Worked full or part time35335 Annual income <$20,00057658

11. Study population (n=1,009) Baseline characteristic No.% Gay/homosexual identity*48348 Male and female sexual partners44345 Circumcised76476 Had any STI12914 * Any mention from multiple options

12. Study population (n=1,009) Baseline characteristic (last 6 months) No.% Unprotected receptive anal intercourse 47347 Unprotected insertive anal intercourse 76476 Received money/goods for sex22623 Provided money/goods for sex10110 Used stimulants36838

13. HIV incidence by subgroups Baseline characteristic No. of infections Person- yearsIncidence (95% CI) TOTAL26928.22.8 (1.8, 4.1)

14. HIV incidence by subgroups Baseline characteristic No. of infections Person- yearsIncidence (95% CI) TOTAL26928.22.8 (1.8, 4.1) Age (years) 18-3020339.75.9 (3.6, 9.1) >306588.51.0 (0.4, 2.2) Education < College Education12492.32.4 (1.4, 4.3) Some College or more14434.63.2 (1.9, 5.4)

15. HIV incidence by subgroups Baseline characteristic No. of infections Person- yearsIncidence (95% CI) Household Income <$20,00017527.63.2 (1.9, 5.2) >=$20,0009392.22.3 (1.0, 4.4) Sexual identity Gay/homosexual19444.14.3 (2.6, 6.7) Other*7482.21.5 (0.6, 3.0) Gender of partners Men only19502.43.8 (2.3, 5.9) Men and women 7405.71.7 (0.7, 3.6) * All other categories besides gay or homosexual

16. HIV incidence by subgroups Baseline characteristic No. of infections Person- yearsIncidence (95% CI) Circumcised No7224.93.1 (1.3, 6.4) Yes19701.32.7 (1.6, 4.2) Any STI No19812.42.3 (1.4, 3.7) Yes7115.8 6.0 (2.4, 12.5)

17. HIV incidence by subgroups Baseline characteristic (last 6 mos) No. of infections Person- yearsIncidence (95% CI) Unprotected receptive anal sex No5485.71.0 (0.3, 2.4) Yes21432.04.9 (3.0, 7.4) Unprotected insertive anal sex No9215.64.2 (1.9, 7.9) Yes17705.72.4 (1.4, 3.9)

18. HIV incidence by subgroups Baseline Characteristic (last 6 mos) No. of infections Person- yearsIncidence (95% CI) Stimulant use No18551.23.3 (1.9, 5.2) Yes8342.52.3 (1.0, 4.6) Received money/goods for sex No21699.83.0 (1.9, 4.6) Yes5207.42.4 (0.8, 5.6) Provided money/goods for sex No23812.12.8 (1.8, 4.3) Yes393.73.2 (0.7, 9.4)

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. 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 Future analyses and conclusions

21. HPTN 061 Acknowledgements 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 Clinical Research Sites, Staff and CABs 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 Sponsored by NIAID, NIDA, NIMH under Cooperative Agreement # UM1 AI068619 and UM1-AI068613