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Original Investigation |

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services

Albert Y. Liu, MD, MPH1,2; Stephanie E. Cohen, MD, MPH1,2; Eric Vittinghoff, PhD3; Peter L. Anderson, PharmD4; Susanne Doblecki-Lewis, MD5; Oliver Bacon, MD, MPH1,2; Wairimu Chege, MD, MPH6; Brian S. Postle, BS7; Tim Matheson, PhD1; K. Rivet Amico, PhD8; Teri Liegler, PhD2; M. Keith Rawlings, MD9; Nikole Trainor, MPH1; Robert Wilder Blue, MSW1; Yannine Estrada, PhD10; Megan E. Coleman, FNP11; Gabriel Cardenas, MPH10; Daniel J. Feaster, PhD12; Robert Grant, MD, MPH13,14; Susan S. Philip, MD, MPH1,2; Richard Elion, MD11,15; Susan Buchbinder, MD1,2,3; Michael A. Kolber, PhD, MD5
[+] Author Affiliations
1San Francisco Department of Public Health, San Francisco, California
2Department of Medicine, University of California, San Francisco
3Department of Epidemiology and Biostatistics, University of California, San Francisco
4Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora
5Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida
6Division of AIDS, National Institutes of Health, Bethesda, Maryland
7DF/Net Research, Inc, Seattle, Washington
8Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor
9Gilead Sciences, Foster City, California
10Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida
11Whitman-Walker Health, Washington, DC
12Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida
13Gladstone Institutes, San Francisco, California
14San Francisco AIDS Foundation, San Francisco, California
15Department of Medicine, George Washington University School of Medicine, Washington, DC
JAMA Intern Med. 2016;176(1):75-84. doi:10.1001/jamainternmed.2015.4683.
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Importance  Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).

Objective  To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.

Design, Setting, and Participants  Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.

Interventions  A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.

Main Outcomes and Measures  Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.

Results  Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion.

Conclusions and Relevance  The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.

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Figures

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Figure 1.
Distribution of Preexposure Prophylaxis Engagement by Visit Week

Engagement is a 5-level ordinal measure, with missing the visit as the lowest level of engagement and increasing levels of engagement based on estimated dosing frequency based on tenofovir diphosphate concentrations. Numbers indicate number of participants contributing data at each time point. Engagement varied by site and by race or ethnicity (P < .001). BLQ indicates below the limit of quantitation.

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Figure 2.
Preexposure Prophylaxis Engagement at Week 48 by Engagement at Week 4

Proportion of participants with no visit attendance or with tenofovir diphosphate (TFV-DP) concentrations in dried blood spot samples in different adherence categories at week 48 are stratified by visit attendance and TFV-DP concentrations at week 4. This analysis includes 325 participants, 287 of whom underwent measurement of TFV-DP levels at week 4 and 38 of whom missed the week 4 visit. Engagement at week 4 strongly correlated with engagement at week 48 (P < .001). BLQ indicates below the limit of quantitation.

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Figure 3.
Sexual Behaviors and Sexually Transmitted Infections (STIs) in the Demo Project

A, Participants reporting condomless receptive anal sex (ncRAS) and mean number of RAS episodes with and without a condom. B, The positive STI findings by anatomic site include Neisseria gonorrhoeae and Chlamydia trachomatis infections and syphilis. The week 48 visit includes testing performed at the optional follow-up visit 4 weeks after week 48.

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