Project PrEPare (ATN082): The acceptability and feasibility of an HIV Pre-Exposure Prophylaxis (PrEP) Trial with young men who have sex with men (YMSM)

1John Stroger Hospital of Cook County, Chicago, IL 2NICHD/PAMAB, Bethesda, MD 3Lifespan Hospital System and Brown Medical School, Providence, RI 4Nova Southeastern University, Ft. Lauderdale, FL 5Westat, Rockville, MD 6Children's Memorial Hospital, Chicago, IL 7University of Alabama at Birmingham, Birmingham, AL.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.56). 12/2012; 62(4). DOI: 10.1097/QAI.0b013e3182801081
Source: PubMed


This study examined the feasibility of a combination prevention intervention for young men who have sex with men (YMSM), an anticipated target population for HIV preexposure prophylaxis (PrEP).

Project PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV prevention intervention (Many Men, Many Voices-3 MV) alone, 3 MV combined with PrEP (tenofovir/emtricitabine), and 3 MV combined with placebo. Eligible participants were 18- to 22-year-old HIV-uninfected men who reported unprotected anal intercourse in the past year. Participants were screened for preliminary eligibility at youth venues and community organizations and were also referred through social networks. Laboratory screening determined final eligibility. Behavioral and biomedical data were collected at baseline and every 4 weeks thereafter for 24 weeks.

Sixty-eight youth (mean age = 19.97 years; 53% African American, 40% Latino) were enrolled; 58 were randomized. Self-reported medication adherence averaged 62% (range, 43%-83%), whereas rates of detectable tenofovir in plasma of participants in the emtricitabine/tenofovir disoproxil fumarate arm ranged from 63.2% (week 4) to 20% (week 24). There were 5 ≥ grade 2 adverse events possibly/probably related to the study medication. Sexual risk behavior declined from baseline to week 24 in all study arms.

The feasibility of enrolling at-risk youth, particularly young men who have sex with men of color, into Project PrEPare has been demonstrated. The acceptability of the group intervention along with counseling and testing was high. Self-reported medication adherence and corresponding plasma drug concentrations were low indicating the need for enhanced adherence counseling. Exploration of PrEP use among youth in nonrandomized open label trials is warranted.

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    • "In sexual health behavioral research, the limited operationalization of HIV risk (i.e., an exclusive focus on condom use) hampers the evidence base for applied HIV prevention science. That is, most behavioral HIV/AIDS researchers continue to focus solely on male condom use as an effective prevention tool (Crosby & Cates, 2012), even while the menu of available prevention options has expanded with emergent technologies such as treatment-as-prevention (TASP), preexposure prophylaxis , microbicides, and female condoms (Cohen et al., 2011; Fava et al., 2013; Hosek et al., 2013; Weeks, Coman, Hilario, Li, & Abbott, 2013). In response to technological advances, clinicians and researchers who develop risk assessment and counseling tools should also consider strategies beyond the traditional (Coates, 2013). "
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    ABSTRACT: "Risky sexual behavior" accounts for the majority of new HIV infections regardless of gender, age, geographic location, or ethnicity. The phrase, however, refers to a relatively nebulous concept that hampers development of effective sexual health communication strategies. The purpose of this paper was to propose development of a shared conceptual understanding of "risky sexual behavior." We reviewed multidisciplinary HIV/AIDS literature to identify definitions of risky sexual behavior. Both the linguistic components and the social mechanisms that contribute to the concept of risky sexual behaviors were noted. Risky sexual behavior was often defined in a subjective manner in the literature, even in the scientific research. We urge a paradigm shift to focus on explicit behaviors and the social context of those behaviors in determining HIV risk. We also propose a new definition that reduces individual biases and promotes a broader discussion of the degree of sexual risk across a diversity of behavioral contexts. Sexual health professionals can strengthen practice and research initiatives by operating from a concise working definition of risky sexual behavior that is broadly transferable and expands beyond a traditional focus on identity-based groups. © 2015 Wiley Periodicals, Inc.
    No preview · Article · Jul 2015 · Public Health Nursing
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    • "PrEP users are also likely to benefit from the support of their HIV-infected partners to improve their adherence. This is in sharp contrast with studies of young MSM, whose adherence to daily PrEP waned over a period of only 6 months from 63% to only 20% [25]. "
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    ABSTRACT: Following US Food and Drugs Administration approval in July 2012 of daily oral tenofovir and emtricitabine for pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk individuals in the USA, there has been much controversy about the implementation of this PrEP regimen in other countries throughout the world, and in Europe in particular. In this review, we focus on the challenges and opportunities of a daily oral PrEP regimen to curb the rising incidence of HIV infection in high-risk groups, and particularly in men who have sex with men. A number of issues would need to be addressed before PrEP could be implemented, including assessing the real effectiveness and cost-effectiveness of daily PrEP, the sustainability of daily adherence, the risk of selecting resistance, the long-term safety, and the risk of change in sexual behavior that might offset the benefit of PrEP. Alternatives to a daily oral PrEP regimen are being explored.
    Full-text · Article · Aug 2013 · BMC Medicine
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    ABSTRACT: On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM.
    No preview · Article · Jul 2013 · Journal of HIV/AIDS & Social Services
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