Background
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 pre-exposure prophylaxis (PrEP).
Methods
Project PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV-prevention intervention (3MV) alone, 3MV combined with PrEP (tenofovir/emtricitabine), and 3MV combined with placebo. Eligible participants were 18–22 year old HIV-uninfected men who reported unprotected anal intercourse (UAI) 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.
Results
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%) while rates of detectable tenofovir in plasma of participants in the FTC/TDF 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.
Conclusions
The feasibility of enrolling at risk youth, particularly YMSM 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 non-randomized, open label trials is warranted.
Black young men who have sex with men (BYMSM) are the group most disproportionately impacted by HIV in the United States and most in need of efficacious interventions to address community-level factors that increase their vulnerability to HIV. The House Ball Community (HBC) is a distinct social network within the larger BYMSM community that may be particularly vulnerable to social norms and stigma around HIV. This study tailored an evidence-based, community-level popular opinion leader (OL) intervention for use within the HBC. The intervention, called POSSE, was then piloted to evaluate feasibility, acceptability and preliminary efficacy. Recruiting opinion leaders from the community and training them to deliver risk reduction messages was found to be feasible and highly acceptable. Community-level surveys (n=406) were completed over 5 waves of data collection. Overall exposure to the intervention increased across waves. Statistically significant (p < .05) declines were observed for multiple sexual partners, condomless anal intercourse with any male partners and with male partners of unknown HIV status. HIV stigma declined as well, but the trend was not statistically significant.
Preexposure prophylaxis active referrals from STI clinics to partner sites are feasible, though drop out was prominent in the initial steps of the continuum. Youth were less likely to link or receive prescriptions, indicating the need for tailored interventions for this vulnerable population.
Studies involving the House Ball Community (HBC) have found high rates of HIV prevalence and undiagnosed HIV infection, as well as unique social and sexual network-related HIV risk and protective behaviors (Murrill et al., 2008; Sanchez et al., 2010). Efforts to understand culturally-appropriate and effective methods of HIV prevention services within the relatively understudied HBC are scarce (Phillips et al., 2011). This qualitative study, utilizing a Diffusion of Innovation Theoretical framework, aimed to explore social norms regarding HIV and accessibility of HIV prevention services within the HBC. Thirty-seven participants (16 community leaders and 21 youth) engaged in focus group discussions. Participants discussed the perceptions of HIV and stigmatization within the HBC, general and HBC-specific risk factors for HIV transmission, as well as HIV prevention needs and strategies for culturally-appropriate HIV interventions. Findings from this qualitative study highlight both the vulnerability of the HBC to HIV transmission and the corresponding support for HIV prevention interventions.
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