Abstract
ObjectivesThe purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection.MethodsMSM and TGW aged 18–30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel.Results248 participants were enrolled into Stage 1A. Participants’ average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity.ConclusionsIn this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population.Trial RegistrationClinicalTrials.gov NCT01283360
Highlights
Young men who have sex with men (MSM) are one of the key groups at risk of HIV acquisition in the United States
The vast majority of these occurred in young Black or Latino MSM [1].transgender women (TGW) continue to have unacceptably high rates of HIV infection [2] especially those who are involved in sex work [3]
We found a positive association between future use intentions and applicator satisfaction (b = .33; p< .001), and based on an interaction effects model, greater gel satisfaction was associated with increased future use intention
Summary
Young men who have sex with men (MSM) are one of the key groups at risk of HIV acquisition in the United States. Adolescents and young adults with HIV infection fare poorly in the US health care system; their rates of diagnosis of HIV infection, access to care, initiation of antiretroviral therapy, and viral suppression are all lower than among older populations [4]. These statistics reinforce the need to develop HIV prevention strategies that will be acceptable to, and used by, young MSM and TGW. Multiple early phase trials of antiretroviral rectal microbicides have been completed or are ongoing [9]. Since both TFV and cyanovirin have demonstrated efficacy in nonhuman primate rectal challenge models [10;11] there is a strong scientific rational for evaluation of rectal microbicides in human efficacy trials
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