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Lessons for Rectal Microbicide Development From an Acceptability Trial of a Placebo Gel Applied Prior to Receptive Anal Intercourse

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Abstract

Rectal microbicides, formulated as a gel to be applied before and/or after intercourse, are promising HIV prevention agents and are now in Phase II trials. However, both an optimal formulation and a practical delivery system are needed to ensure that the target population will use the product once efficacy is demonstrated. The precise dynamics of lubricant application by gay and bisexual men who practice anal sex and the qualities they seek in these products are underexplored. As part of a Phase I microbicide acceptability and adherence study conducted in one Puerto Rican and two continental U.S. cities, we recruited 124 young men who have sex with men (YMSM) with a history of unprotected receptive anal intercourse (RAI) and provided them with 40 rectal applicators containing a placebo gel to use prior to RAI during a 12-week period as a proxy for an eventual rectal microbicide. Ninety-five YMSM completed the trial. Their varied preferences as to product viscosity, durability, residue, and mode of application provide important lessons for the design of a product that will be satisfactory to users. Despite many reservations, the participants used the product frequently and found ways to overcome a range of obstacles. A successful rectal microbicide product may need to be presented in a range of viscosities to attract a broad client base.

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Acknowledgments

This research was sponsored by the US National Institutes of Health (NIH), including NICHD and NIMH, under R01 HD59533 (Carballo-Diéguez and McGowan, Co-PIs) and co-sponsored by CONRAD. Additional support came from the National Institute of Mental Health to the HIV Center for Clinical and Behavioral Studies at NY State Psychiatric Institute and Columbia University (P30-MH43520; Principal Investigator: Robert H. Remien).

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Authors and Affiliations

  1. HIV Center for Clinical & Behavioral Studies, New York State Psychiatric Institute/Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA

    Timothy Frasca, Rebecca Giguere, Curtis Dolezal & Alex Carballo-Diéguez

  2. Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA

    Mobolaji Ibitoye

  3. Department of Pediatrics, Medical Sciences Campus, University of Puerto Rico, San Juan, PR, USA

    Irma Febo

  4. Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

    Ross D. Cranston & Ian McGowan

  5. The Fenway Institute, Fenway Health, Boston, MA, USA

    Kenneth Mayer

Authors
  1. Timothy Frasca
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  2. Rebecca Giguere
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  3. Mobolaji Ibitoye
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  4. Curtis Dolezal
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  5. Irma Febo
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  6. Ross D. Cranston
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  7. Kenneth Mayer
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  8. Ian McGowan
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  9. Alex Carballo-Diéguez
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Correspondence to Timothy Frasca.

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Frasca, T., Giguere, R., Ibitoye, M. et al. Lessons for Rectal Microbicide Development From an Acceptability Trial of a Placebo Gel Applied Prior to Receptive Anal Intercourse. Arch Sex Behav 46, 1101–1109 (2017). https://doi.org/10.1007/s10508-016-0735-1

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  • DOI: https://doi.org/10.1007/s10508-016-0735-1

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