Microbicides are products that can be applied to the lining of the vagina or rectum to try and reduce the risk of HIV infection associated with unprotected sexual 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 look at the safety and acceptability of these products in people who practice rectal sex. In the US, one of the most vulnerable groups for getting HIV infection are young men, especially young Black and Latino men. Our study will be conducted with an ethnically diverse sample of HIV-negative men, 18-30 year-olds, who report engaging in receptive rectal intercourse using condoms inconsistently or not at all. Our ultimate goal is to test whether this highly vulnerable population could safely use the microbicide candidate VivaGel" and whether patterns of use of a placebo indistinguishable from VivaGel" suggest that the product would be correctly and consistently used in real life circumstances. Our study will be conducted in two stages in which acceptability and adherence will be studied first using a placebo gel applied with a specifically designed rectal delivery device in, or prior to, real-life sexual encounters. Subsequently, the safety of VivaGel" will be studied among those men who show the highest adherence to gel use (defined as using the study product during e80% episodes). This safety phase will consist of a single dose of gel followed by one week of daily dosing with the gel. At the beginning of each of these two stages, we will provide all participants condom-use counseling following the Personalized Cognitive Risk-Reduction Counseling protocol, a risk-reduction counseling method to prevent HIV and STIs that showed efficacy in a randomly controlled trial. All of the participants will be closely monitored with clinical, laboratory, and behavioral assessments. Quantitative and qualitative research methods will be used, as well as combination of self-reports, biomarkers, and product recounts. The study will be undertaken by University of Pittsburgh in Pittsburgh, PA., and the HIV Center for Clinical and Behavioral Studies (Columbia University and NYS Psychiatric Institute) in NY, NY. There will be three clinical trial sites: the University of Pittsburgh in Pittsburgh, PA;the Fenway Community Health in Boston, MA;and the University of Puerto Rico Clinical Trial Unit in San Juan, PR. This innovative study will contribute to the development of a safe and effective microbicide for the prevention of HIV infection.

Public Health Relevance

Young men who have sex with men (MSM), especially Black and Latino MSM, represent one of the highest risk groups for HIV infection in the US population. Microbicide gels are products that can be applied to the lining of the rectum or vagina to prevent, or at least significantly reduce, the risk of HIV infection associated with unsafe sex. This study seeks to establish whether this highly vulnerable population could safely use a microbicide gel (VivaGel) and whether patterns of use of a placebo, indistinguishable from VivaGel, suggest that the product would be correctly and consistently used in real life circumstances.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD059533-04
Application #
8307901
Study Section
AIDS Clinical Studies and Epidemiology Study Section (ACE)
Program Officer
Mofenson, Lynne M
Project Start
2009-09-01
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
4
Fiscal Year
2012
Total Cost
$1,617,391
Indirect Cost
$214,102
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
McGowan, Ian (2014) The development of rectal microbicides for HIV prevention. Expert Opin Drug Deliv 11:69-82
Carballo-Diéguez, Alex; Giguere, Rebecca; Dolezal, Curtis et al. (2014) Adherence to rectal gel use among mainly ethnic minority young men who have sex with men during a 3-month placebo gel trial: implications for microbicide research. AIDS Behav 18:1726-33
Carballo-Diéguez, Alex; Giguere, Rebecca; Dolezal, Curtis et al. (2014) Rectal-specific microbicide applicator: evaluation and comparison with a vaginal applicator used rectally. AIDS Behav 18:1734-45
McGowan, Ian (2011) Rectal microbicides: can we make them and will people use them? AIDS Behav 15 Suppl 1:S66-71
Rudy, Bret J; Kapogiannis, Bill G; Lally, Michelle A et al. (2010) Youth-specific considerations in the development of preexposure prophylaxis, microbicide, and vaccine research trials. J Acquir Immune Defic Syndr 54 Suppl 1:S31-42
McGowan, Ian (2010) Microbicides for HIV prevention: reality or hope? Curr Opin Infect Dis 23:26-31