Original Paper

AIDS and Behavior

, Volume 16, Issue 7, pp 1761-1774

“Tell Juliana”: Acceptability of the Candidate Microbicide VivaGel® and Two Placebo Gels Among Ethnically Diverse, Sexually Active Young Women Participating in a Phase 1 Microbicide Study

  • Alex Carballo-DiéguezAffiliated withHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Email author 
  • , Rebecca GiguereAffiliated withHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University
  • , Curtis DolezalAffiliated withHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University
  • , Beatrice A. ChenAffiliated withDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of PittsburghCenter for Family Planning Research, Magee-Womens Research Institute
  • , Jessica KahnAffiliated withCincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine
  • , Greg ZimetAffiliated withDivision of Medicine, Indiana University
  • , Marina MabragañaAffiliated withHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University
  • , Cheng-Shiun LeuAffiliated withHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University
  • , Ian McGowanAffiliated withDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of PittsburghCenter for Family Planning Research, Magee-Womens Research Institute

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Abstract

This study assessed acceptability of the candidate microbicide VivaGel® and two placebo gels among 61 sexually active young US and Puerto Rican women at three sites. Participants were randomly assigned to use one of the gels twice per day for 14 days. At trial completion, 59% of the women in the VivaGel® group reported being likely to use the gel in the future, whereas 23% were unlikely to use it and 18% were undecided. Participants reported problems with all three gels, including the “universal” placebo containing hydroxyethyl cellulose (HEC). The most frequent complaints were leakage, interference with sexual behavior, and decreased sexual satisfaction. Some of the complaints are not new but remain unresolved. Women’s perceived risk of HIV infection may determine whether the gels are used. Users also may want a choice of viscosity. Poor acceptability of vaginal microbicide formulations may result in poor adherence to gel use during efficacy trials and compromise validity of results.

Keywords

Microbicide acceptability HIV prevention HEC Leakage

Resumen

Este estudio evaluó la aceptabilidad del candidato a microbicida VivaGel y de dos geles placebo en una muestra de 61 mujeres jóvenes puertorriqueñas y estadounidenses sexualmente activas reclutadas en tres sitios. Las participantes fueron asignadas aleatoriamente a usar uno de los geles dos veces por día durante 14 días. Al completar el estudio, el 59% de las mujeres que usaron VivaGel reportaron que era probable que usaran el gel en el futuro mientras que el 23% dijeron que era improbable y el 18% estaban indecisas. Las participantes reportaron problemas con los tres geles, incluyendo el placebo “universal” que contiene HEC. Los problemas se centraron en goteo o pérdida, interferencia con el comportamiento sexual, y disminución de la satisfacción sexual. Algunas quejas no son nuevas pero aún no están resueltas. El uso del gel estaría condicionado a la percepción de riesgo de infección por VIH. Las usuarias pueden desear opciones en viscosidad. La pobre aceptabilidad de un microbicida vaginal puede resultar en escasa adherencia al correcto uso del gel durante estudios de eficacia y puede comprometer la validez de los resultados.