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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

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Abstract

To study adherence to product use prior to a Phase I microbicide trial, we recruited 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. Ninety-five YMSM completed the trial. Based on a Computer Assisted Self Interview, 83 participants had receptive anal intercourse (RAI) (Median 12 occasions) using gel on 82.4 % of occasions (SD 26.7; 0–100). Based on an interactive voice response system, 88 participants had RAI (Median 10 occasions) using gel on 87.9 % of occasions (SD 20.0; 20–100). By applicator counts the median gel use was 12. Participants showed high adherence to gel use. Those who did not use the product consistently (n = 40) adduced not having it with them (85 %), forgetting to use it (48 %), not wanting to use it (13 %), partner refusal (10 %) and gel messiness (10 %).

Resumen

Para estudiar la adherencia al uso del producto antes de realizar un ensayo Fase I de un microbicida, reclutamos hombres jóvenes que tienen sexo con hombres con una historia de sexo anal receptivo sin protección y les proveímos 40 aplicadores rectales que contenían un gel placebo para usar antes del sexo anal receptivo durante un período de 12 semanas. Noventa y cinco hombres completaron el ensayo. Basado en un Auto-Entrevista Asistida por Computadora, 83 participantes tuvieron sexo anal receptivo (Media = 12 ocasiones), usando el gel en 82.4 % de las ocasiones (SD 26.7; 0-100). Basado en un sistema telefónico interactivo, 88 participantes tuvieron sexo anal receptivo (Media = 10 ocasiones) usando el gel en 87.9 % de las ocasiones (SD 20.0; 20-100). Por el recuento de aplicadores, la media del número de veces de uso del gel fue 12. Los participantes demostraron alta adherencia al uso del gel. Los que no usaron el producto consistentemente (n = 40) citaron no tenerlo con ellos (85 %), olvidarse de usarlo (48 %), no querer usarlo (13 %), rechazo de la pareja (10 %) y que el gel ensuciaba (10 %).

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Acknowledgments

The authors would like to thank Marina Mabragaña and Mobolaji Ibitoye for their help in cleaning and coding the qualitative data for this paper. In addition, we greatly appreciate the hard work of the study staff at the sites, and are indebted to the study participants for volunteering their time and for their willingness to discuss personal matters with us. 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 Remien). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH.

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Authors and Affiliations

  1. HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute, Columbia University, 1051 Riverside Drive, New York, NY, 10032, USA

    Alex Carballo-Diéguez, Rebecca Giguere, Curtis Dolezal, Cheng-Shiun Leu, Juan Valladares & Timothy Frasca

  2. School of Public Health, Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, USA

    José Bauermeister

  3. Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

    Rita Labbett & Ross D. Cranston

  4. Department of Pediatrics, Gama Project, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico

    Irma Febo

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

    Kenneth Mayer

  6. Department of Obstetrics, Gynecology, and Reproductive Sciences, Center for Family Planning Research, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA, USA

    Ian McGowan

Authors
  1. Alex Carballo-Diéguez
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  2. Rebecca Giguere
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  3. Curtis Dolezal
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  4. José Bauermeister
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  5. Cheng-Shiun Leu
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  6. Juan Valladares
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  7. Timothy Frasca
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  8. Rita Labbett
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  9. Ross D. Cranston
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  10. Irma Febo
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  11. Kenneth Mayer
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  12. Ian McGowan
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Correspondence to Alex Carballo-Diéguez.

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Carballo-Diéguez, A., Giguere, R., Dolezal, C. et al. 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, 1726–1733 (2014). https://doi.org/10.1007/s10461-014-0768-1

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  • DOI: https://doi.org/10.1007/s10461-014-0768-1

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