Men who have sex with men (MSM) are disproportionately affected by HIV/AIDS globally. A recent phase 3 clinical trial (iPrEx) showed that oral (PrEP) for HIV prevention with daily oral emtrictabine/tenofovir provided 44% additional protection to high-risk HIV-uninfected MSM. Higher levels of adherence and detection of drug in biological specimens was strongly associated with protective effect. Health departments are currently planning demonstration projects to evaluate whether PrEP can be delivered in community settings. Promoting adherence and reducing risk behaviors will be central to supporting individuals using PrEP in implementation programs. Multi-modal approaches to supporting adherence will likely have the largest and most sustained benefit. Two complementary interventions are particularly promising as components of a combined adherence intervention. First, Next Step Counseling, a client-centered, context-driven counseling approach proved feasible and acceptable when piloted at the end of the iPrEx study. We have recently developed integrated Next Step Counseling (iNSC), merging risk reduction and adherence support counseling, to allow more streamlined delivery in community settings. A second approach, short message system (SMS) support, has been shown to improve antiretroviral adherence rates and lower HIV viral load among HIV-infected patients in Africa. In addition to adherence support, easy-to-use, inexpensive, and accurate tools for monitoring PrEP use in community settings will be critical. In mid 2011, the San Francisco Department of Public Health will launch an 18-month PrEP demonstration project among 400 MSM. In the first phase of this project, we propose to determine the patterns and correlates of adherence and risk behaviors among HIV-uninfected MSM receiving PrEP in a city-sponsored demonstration project. We will also evaluate two novel biological markers of adherence for their utility in monitoring adherence in clinical settings. Data from this first phase will inform the refinement and deployment of a multimodal intervention to promote adherence and reduce risk among MSM PrEP users. In the second phase of this study, we will evaluate the effectiveness of the iNSC+SMS intervention in promoting PrEP adherence and reducing risk behaviors in a randomized clinical trial conducted at the municipal STD clinic in San Francisco. The long term goal of the EPIC study (Enhancing PrEP in Community Settings) is to optimize support of MSM utilizing PrEP in community settings.

Public Health Relevance

This research will study patterns of pill-use and risk practices among men who have sex with men taking a daily pill for HIV prevention in a community setting, also known as pre-exposure prophylaxis, or PrEP. We will also test new approaches to monitoring pill-taking in real-world settings and whether a new strategy to help support daily pill use is effective. At the end of this 5-year project, we hope to have new effective strategies to monitor and promote prevention pill use in community settings.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH095628-05
Application #
8877312
Study Section
Special Emphasis Panel (ZMH1)
Program Officer
Stirratt, Michael J
Project Start
2011-09-06
Project End
2017-06-30
Budget Start
2015-07-01
Budget End
2017-06-30
Support Year
5
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Public Health Foundation Enterprises
Department
Type
DUNS #
082199324
City
City of Industry
State
CA
Country
United States
Zip Code
91746
Tang, Eric C; Vittinghoff, Eric; Anderson, Peter L et al. (2018) Changes in Kidney Function Associated With Daily Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Preexposure Prophylaxis Use in the United States Demonstration Project. J Acquir Immune Defic Syndr 77:193-198
Hughes, Shana D; Sheon, Nicolas; Andrew, Erin V W et al. (2018) Body/Selves and Beyond: Men's Narratives of Sexual Behavior on PrEP. Med Anthropol 37:387-400
Koss, Catherine A; Hosek, Sybil G; Bacchetti, Peter et al. (2018) Comparison of Measures of Adherence to Human Immunodeficiency Virus Preexposure Prophylaxis Among Adolescent and Young Men Who Have Sex With Men in the United States. Clin Infect Dis 66:213-219
Doblecki-Lewis, Susanne; Liu, Albert Y; Feaster, Daniel J et al. (2018) Patterns and Correlates of Participant Retention in a Multi-City Pre-Exposure Prophylaxis Demonstration Project. J Acquir Immune Defic Syndr 79:62-69
Gandhi, Monica; Murnane, Pamela M; Bacchetti, Peter et al. (2017) Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen. AIDS 31:2245-2251
Doblecki-Lewis, Susanne; Liu, Albert; Feaster, Daniel et al. (2017) Healthcare Access and PrEP Continuation in San Francisco and Miami After the US PrEP Demo Project. J Acquir Immune Defic Syndr 74:531-538
Bacon, Oliver; Gonzalez, Rafael; Andrew, Erin et al. (2017) Brief Report: Informing Strategies to Build PrEP Capacity Among San Francisco Bay Area Clinicians. J Acquir Immune Defic Syndr 74:175-179
Zheng, Jia-Hua; Rower, Caitlin; McAllister, Kevin et al. (2016) Application of an intracellular assay for determination of tenofovir-diphosphate and emtricitabine-triphosphate from erythrocytes using dried blood spots. J Pharm Biomed Anal 122:16-20
Liu, Albert Y; Cohen, Stephanie E; Vittinghoff, Eric et al. (2016) Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services. JAMA Intern Med 176:75-84
Carlo Hojilla, J; Koester, Kimberly A; Cohen, Stephanie E et al. (2016) Sexual Behavior, Risk Compensation, and HIV Prevention Strategies Among Participants in the San Francisco PrEP Demonstration Project: A Qualitative Analysis of Counseling Notes. AIDS Behav 20:1461-9

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