Funding Source and Project Period: NICHD R01; 2003 - 2007

Collaborating Institutions and Key Personnel:

HIV Center:
Principal Investigator: Alex Carballo-Diéguez, PhD.
Co-Investigators: Theresa Exner, Ph.D.; Curtis Dolezal, Ph.D.
Postdoctoral Fellow: Peter Lin, Ph.D.

Fenway Community Health
Co-Principal Investigator: Kenneth Mayer, M.D.
Project Manager: Robert Pickard, M.A.

Project Overview:
Unprotected receptive anal intercourse is the top ranking sexual risk behavior leading to HIV infection. Although condoms can prevent viral transmission, large numbers of uninfected men and women who have receptive anal sex with HIV-positive men or men of unknown serostatus do not use condoms consistently – either by choice or due to reasons out of their control. For them, rectal microbicides could be a protection alternative. Rectal microbicides need to be not only efficacious against HIV but, equally important, products that people are able and willing to use. This latter issue is generally referred to as "acceptability." This study is assessing rectal microbicide acceptability among men who have sex with men (MSM) and women.

With MSM, we are conducting an actual trial using a microbicide placebo – that is, a product that is inert and presents no safety concerns yet is undistinguishable from a "real" microbicide. With women, we are conducting in-depth interviews about acceptability but no actual trial.

Focusing on HIV-negative MSM who have receptive anal intercourse (RAI) using condoms inconsistently or not at all, the primary aims of this study are (1) to determine, through a rectal gel volume escalation trial, the maximum acceptable volume of gel; (2) to determine, through a formulation preference trial, which rectal microbicide delivery vehicle (gel or suppository) is preferred; and (3) to assess, through qualitative and quantitative research methods, whether or not there are different attitudes about and intentions to use rectal microbicide gels as opposed to suppositories and whether or not attitudes and intentions change from before to after the product trial.

Focusing on HIV-negative women who engage in anal sex with men using condoms inconsistently or not at all, the secondary aims of this study are (1) to elicit, through qualitative in-depth interviews, the psychological, social, and cultural factors associated with anal sex and (2) to assess, through qualitative and quantitative techniques, attitudes, intention to use, and preferences concerning rectal microbicide gels and suppositories.

This project is being conducted as a close collaboration between researchers at the HIV Center for Clinical and Behavioral Studies at N.Y. State Psychiatric Institute and Columbia University in New York and Fenway Community Health (FCH), the largest provider of medical, mental health, and community education for gay men, lesbians, bisexuals, and transgendered individuals in New England. All participant recruitment and evaluation takes place at FCH in Boston.

Publications:

Carballo-Diéguez, A., Exner, T., Dolezal, C., Pickard, R., Lin, P., and Mayer, K.H. (2007). Rectal microbicide acceptability: Results of a volume escalation trial. Sexually Transmitted Diseases, 34(4), 224-229.

Carballo-Diéguez, A., Dolezal, C., Bauermeister, J.A., Ventuneac, A., O’Brien, W., and Mayer, K. (2008). Preference for gel over suppository as delivery vehicle for a rectal microbicide: Results of a randomize, crossover acceptability trial among men who have sex with men. Sexually Transmitted Infections, 84(6), 483-487.

Carballo-Diéguez, A., Bauermeister, J., Ventuneac, A., Dolezal, C., Mayer, K. Why rectal douches may be acceptable rectal-microbicide delivery vehicles for MSM. Sexually Transmitted Diseases, 2 Dec 2009 [Epub ahead of print].

Exner, T.M., Correale, J., Carballo-Diéguez, Al, Salomon, L., Morrow, K.M., Dolezal, C., and Mayer K. (2008). Women’s anal sex practices: Implication for formulation and promotion of a rectal microbicide. AIDS Education and Prevention, 20(2), 148-159.

Maynard, E., Carballo-Diéguez, A., Ventuneac, A., Exner, T., and Mayer, K. (2009). Women’s experiences with anal sex: Motivations and implications for STI prevention. Perspectives on Sexual and Reproductive Health, 41, 142-149.