Funding Source and Project Period: NICHD, 2009-2013

Collaborating Institutions and Key Personnel:

HIV Center:
Principal Investigators: Dr. Alex Carballo-Diéguez, Dr. Ian McGowan

University of Pittsburgh:
Co-Principal Investigator: Ian McGowan, M.D., Ph.D., F.R.C.P.
Co-Investigator: Ross D. Cranston, M.D., F.R.C.P.

Fenway Community Health:
Co-Investigator: Kenneth Mayer, M.D.
University of Puerto Rico:
Co-Investigator: Irma Febo, M.D.


Project Overview:
(from abstract)

In the US, it has been documented that young African-American men who have sex with men (MSM) have HIV seroincidence rates similar to, or greater than those found in sub-Saharan Africa. Latino MSM also have disproportionately high prevalence rates of HIV. Furthermore, new infections continue to occur in young white MSM. This situation occurs despite the fact that these individuals are part of a generation that grew up in the era of AIDS, in major urban centers of the US, exposed in and out of school to all kinds of HIV-related information, and targeted by HIV prevention programs that promoted sexual abstinence or condom use. While efforts continue to be made to encourage sexually active young MSM to have safer sex, the undeniable fact is that many of them are not using condoms correctly and consistently. Alternatives to condoms are sorely needed. Strategies that integrate behavior change and new biomedical tools may be such alternatives.

Rectal microbicides could be an important new prevention tool. Microbicides are products that could be applied to the rectal or vaginal mucosa with the intent of preventing, or at least significantly reducing, transmission of sexually transmitted infections (STIs) including HIV. Products are currently under development that could be presented as a gel or enema to be applied rectally prior to anal intercourse. The safety and effectiveness of vaginal microbicides have been studied widely in women at risk of infection but there are very few studies looking at the safety and acceptability of microbicides when used rectally. It is thought that once a vaginal microbicide is developed, it will be used for both vaginal and rectal intercourse. It is therefore important that we examine the safety and acceptability of these products in people who practice receptive anal intercourse (RAI).

This four-year study is addressing important gaps by examining microbicide safety, acceptability, and adherence in younger populations, particularly ethnic minority MSM. An ethnically diverse sample will be enrolled of HIV-negative MSM, 18- to 30-year-olds, who report engaging in RAI using condoms inconsistently or not at all. Our goal is to test whether this highly vulnerable population could safely use a microbicide candidate and whether patterns of use of a placebo gel suggest that the product would be correctly and consistently used in real life circumstances.

This study will be conducted in two stages. In Stage 1A, 240 eligible participants will undergo a baseline medical evaluation for both history and presence of anorectal health pathologies or injuries including STIs and HIV, and a detailed Web-based baseline behavioral assessment. The first 120 eligible participants reporting unprotected RAI in the previous 3 months will continue onto Stage 1B, the Acceptability and Adherence Trial. In this trial, they will apply a placebo gel rectally prior to each episode of RAI over 3 months, reporting each use via an interactive voice response phone reporting system. They will complete a Web-based questionnaire on microbicide acceptability and take part in a video teleconference at the end of the 3 months to be interviewed about their experiences.



The first 42 eligible participants completing Stage 1B with good adherence (operationalized as study product use during ≥80% of RAI episodes) will continue on to Stage 2, the Phase 1 Safety and Acceptability Trial. In this trial, participants will be randomized to receive either UC781 gel or HEC placebo gel and will be evaluated for any adverse events after they apply a single dose of the gel in the study clinic, and again after they self-administer once-daily outpatient doses for 7 days. Participants will again be asked to call a phone reporting system each time they use the gel at home. They will also undergo an end-trial Web-based questionnaire on acceptability and participate in a final teleconference.