207497 Acceptability of the microbicide UC781 when administered rectally among HIV negative women and men

Monday, November 9, 2009: 3:15 PM

Ana M. Ventuneac, PhD , HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY
Alex Carballo-Dieguez, PhD , HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY
Robert Dennis , Center for HIV Prevention Research, David Geffen School of Medicine at UCLA, Los Angeles, CA
Ian McGowan, MD , Magee Womens Research Institute, University of Pittsburg Medical Center, Pittsburgh, PA
Amy Adler, RN, MSN, FNP , Lemon Tree Tours, Mill Valley, CA
Elena Khanukhova , Center for HIV Prevention Research, David Geffen School of Medicine at UCLA, Los Angeles, CA
Charles Price , Center for HIV Prevention Research, David Geffen School of Medicine at UCLA, Los Angeles, CA
Terry Saunders , Center for HIV Prevention Research, David Geffen School of Medicine at UCLA, Los Angeles, CA
Chomchay Siboliban , Center for HIV Prevention Research, David Geffen School of Medicine at UCLA, Los Angeles, CA
Peter Anton, MD , Center for HIV Prevention Research, David Geffen School of Medicine at UCLA, Los Angeles, CA
  
BACKGROUND: Our goal was to determine the acceptability of UC781 (0.1% and 0.25% gel) compared to a placebo gel when applied rectally among HIV-uninfected women and men who report a history of receptive anal intercourse at least once in lifetime.

METHODS: Thirty-six HIV-uninfected participants (10 women and 26 men)were enrolled in a randomized, blinded, placebo-controlled safety and acceptability trial of the vaginal microbicide gel UC781 applied rectally. Screening, enrollment and follow-up visits took place over an 8-week period. Participants were randomized to three groups: 0.1% UC781 gel, 0.25% UC781 gel, or a placebo gel (12 per group). Acceptability was assessed after seven days of product use through both, a structured, Web-based computer administered self-interview and a semi-structured individual interview.

RESULTS: Participants found UC781 gel highly acceptable. Acceptability was similar across the three study conditions to both women and men. The study products received favorable ratings overall and on attributes such as color, smell, consistency, feeling in rectum immediately after insertion and/or 30 minutes after insertion, and application process. Only a few participants reported being bothered by leakage.

CONCLUSIONS: The results suggest that the acceptability of UC781 gel is comparable to that of a placebo gel. Acceptability research is essential in early phases of microbicide development to aid in understanding user preferences for a product. Making changes to a product earlier rather than later in development will reduce the total cost of drug development significantly and ultimately achieve increased use of a product that would decrease the global burden of HIV.

Learning Objectives:
Assess acceptability of microbicide and placebo gels applied rectally among HIV-uninfected men and women who have a history of receptive anal intercourse.

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: The presentation discusses acceptability of UC781 gel.

Qualified on the content I am responsible for because: I have experience in HIV prevention research.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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