Background: Adherence to product use is the cornerstone of microbicide studies. This is the first study to assess how frequently mainly ethnic minority MSM, ages 18-30, with a history of unprotected receptive anal intercourse (RAI) in the prior year, would self-administer gel using a rectal-specific applicator prior to RAI in their everyday lives.
Methods: Recruitment took place in Boston, MA; Pittsburgh, PA, and San Juan, PR. Participants received 40 applicators prefilled with 4mL of hydroxyethylcellulose placebo gel that they could use over 12 weeks. They were asked to self-administer a dose within 90 minutes prior to RAI and report RAI and gel use at least weekly through an interactive voice response system (IVRS). At week 12, they responded to a Computer Assisted Self Interview (CASI) and underwent an in-depth interview. Participants were repeatedly counseled that the study focused on product adherence and that the gel would not protect against HIV.
Results: 124 MSM were enrolled (Mean age 23.1; 41% White, 40% Latino, 8% African American, 11% mixed/other). 95 participants completed the trial (18 were lost to follow up and 11 withdrew). Based on the IVRS, (n=94, 1 missing data), 88 participants had RAI (Median 10 occasions) using gel on 81.1% of occasions (SD 23.3, range 0-100). Based on CASI, (n=86, 9 refused to answer RAI question) 83 participants had RAI (Median 12 occasions) using gel on 81.7% of occasions (SD 26.7; 0-100). Based on CASI, 69% of men typically applied gel immediately before RAI; 40 inconsistent users gave as reasons not having gel with them (85%), forgetting to use it (48%), not wanting to use it (13%), partner refusal (10%) and gel messiness (10%).
Conclusions: Ethnically diverse young MSM with a history of unprotected RAI showed high adherence to gel use. Adherence to product use could potentially be enhanced by improving portability, facilitating the development of routines to counteract forgetfulness, and improving motivation and partner negotiation skills. Participant retention was challenging and needs further study. Two different self-report methods provided convergent results. Limitation: A product of known efficacy could have different uptake than the placebo used in this study.
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