1. Incidence and Correlates of STIs among Black Men who have Sex with Men Participating in a US PrEP Study HPTN 073 Lisa Hightow-Weidman, Manya Magnus, Geetha Beauchamp, Christopher Hurt, Steve Shoptaw, Lynda Emel, Estelle Piwowar-Manning, Kenneth Mayer, LaRon E. Nelson, Leo Wilton, Phaedrea Watkins, Sheldon Fields, Darrell Wheeler

2. Blacks/African Americans have the most severe burden of HIV of all racial/ethnic groups in the United States. Among all African Americans diagnosed with HIV in 2014, an estimated 57% (11,201) were gay or bisexual men. From 2005 to 2014, the number of new HIV diagnoses among young Black gay and bisexual men (aged 13 to 24) increased 87%. HIV Among Black MSM CDC, 2014

3. STI acquisition has ranged from 28%-57% in several recent PrEP studies 1-4 Meta-analysis found MSM on PrEP 5 –25.3x more likely to acquire Gonorrhea, –11.2x more likely to acquire Chlamydia and –44.6x more likely to acquire syphilis PrEP and STI acquisition among MSM 1 McCormack et al. Lancet 2015; 387: 53-60 2 Molina et al. NEJM 2015; 373: 2237-46 3 Volk et al. CID 2015; 61: 1601-3 4 Liu et al. JAMA Int Med 2015; 176: 75-84 5 Kojima AIDS 2016 June 14 [Epub]

4. 226 HIV-uninfected BMSM enrolled from August 2013 - September 2014 Los Angeles, CA Washington, DC Chapel Hill, NC

5. All participants received client-centered care coordination and offered daily oral PrEP with once daily Truvada® (emtricitabine/tenofovir). Men followed for 12 months with scheduled clinical visits STI testing (rectal and urine NAAT for gonorrhea and chlamydia, RPR for syphilis) at weeks 26 and 52. Study Design Comprehensive HIV risk assessmentDevelopment of Prevention PlanIntensive risk reduction counselingLinkages to support servicesFollow-up between study visits Client-Centered Care Coordination

6. Logistic regression was used to examine the unadjusted and adjusted associations between STI prevalence and baseline characteristics. Associations between age, PrEP acceptance and sexual risk taking behaviors and any STI evaluated using generalized estimating equations (GEE) to account for the repeated observations at weeks 26 and 52. Incidence rates and confidence intervals calculated based on Poisson distribution. Methods

7. Demographics (n=226) Age <25 years, n(%) Median (IQR) 91 (40.3) 26 years (23-32) Education Some college or more, n(%)160 (70.8) Full-time employed, n(%)85 (37.6) Health Insurance, n(%)155 (68.6) Income <$20,000, n(%)108 (47.8)

8. STIs at Screening and Follow-up Pharyngeal STIs were not specifically tested for per protocol but were reported as AEs after enrollment if detected. Overall STI prevalence did not increase over time; p=0.8463

9. STI Incidence by PrEP Uptake Study VisitCases per 100 PY (95% CI) P-value PrEP acceptedPrEP declined Screening32.8 (24.3, 43.2) 26.8 (12.9, 49.3) 0.56 Week 2636.2 (25.0, 52.4) 22.5 (8.4, 59.6) 0.37 Week 5237.6 (26.3, 53.8) 23.5 (8.8, 62.5) 0.37

10. Acquisition of STIs Men <25 years of age more likely to have an STI at screening than men ≥25 years –25.3% vs. 6.7%; OR 4.39, (95% CI: 1.91, 10.11) Sixty participants acquired ≥1 STI during follow-up Nine participants had an STI at both follow-up visits.

11. Correlates of Incident STIs In a multivariable model: –Having an STI diagnosis at screening was associated with ≥1 incident STI at week 26 or week 52 OR 4.02 (95% CI 1.79,9.01) –Study site, age, self-report of condomless sex, alcohol or drug use before or during sex, self-reported PrEP adherence and total and mean C4 sessions were not associated with having an incident STI.

12. Self-reported Condomless Anal Sex No statistically significant change over time Insertive Receptive

13. STIs at HIV Seroconversion Among the 8 participants who seroconverted –1 had syphilis at week 26 –1 had urethral gonorrhea at week 26 No data yet available regarding PrEP adherence and STIs –See Wheeler et al. Abstract WEAC0104 "Correlates for levels of self-reported PrEP adherence among Black men who have sex with men in 3 U.S. cities"

14. Only tested for STIs at baseline and weeks 26 and 52 –Recent data suggest more frequent testing (q3 months) likely warranted 1 –5 additional cases diagnosed outside of the protocol-specified testing windows and 3 cases of presumptive treatment at other clinics Limitations Ref: 1 Liu et al. JAMA Int Med 2015; 176: 75-84

15. The prevalence of STIs in this trial was lower than in prior PrEP trials with no increase in incidence over time. There was no significant difference in STI incidence among BMSM who accepted or declined PrEP. BMSM with STIs at PrEP initiation may require additional counseling and more frequent STI testing during follow-up. Conclusions

16. 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. ACKNOWLEDGEMENTS HPTN 073 was sponsored by the US NIAID, the US NIMH and the US NIDA. Study drug was provided by Gilead Sciences, Inc. We would like to thank the HPTN 073 participants as well as the investigators and staff at participating sites and the protocol team for their dedication to this project

17. BACKUP SLIDES

18. STIs in prior PrEP studies PROUD 1 57% in immediate group and 50% in deferred group diagnosed with >1 bacterial STI during f/u IPERGAY 2 41% in TDF/FTC arm and 33% placebo arm diagnosed with a new STI (39% rectal) Kaiser Study 3 28.5% were diagnosed with at least 1 STI during follow-up After 6 months of PrEP use, 30% of PrEP users were diagnosed with any STI, after 12 months was 50% 3 city Demo 4 50.9% diagnosed with at least 1 STI during follow-up Incidence (95% CI) was 90 (81-99) per 100 person-years for any STI 1 McCormack et al. Lancet 2015; 387: 53-60 2 Molina et al. NEJM 2015; 373: 2237-46 3 Volk et al. CID 2015; 61: 1601-3 4 Liu et al. JAMA Int Med 2015; 176: 75-84