"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.

Title"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.
Publication TypePublication
Year of Publication2012
AuthorsCarballo-Diéguez A, Giguere R, Dolezal C, Chen BA, Kahn J, Zimet G, Mabragaña M, Leu C-S, McGowan I
JournalAIDS Behav
Volume16
Issue7
Pagination1761-74
Date Published2012 Oct
ISSN1573-3254
KeywordsAdministration, Intravaginal, Adolescent, Anti-Infective Agents, Local, Consumer Behavior, Dendrimers, Female, Gels, HIV Infections, Humans, Interviews as Topic, Logistic Models, Patient Acceptance of Health Care, Placebos, Polylysine, Puerto Rico, Qualitative Research, Sexual Behavior, Socioeconomic Factors, Surveys and Questionnaires, United States, Young Adult
Abstract

<p>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.</p>

DOI10.1007/s10461-011-0028-6
Alternate JournalAIDS Behav
PubMed ID21863338
PubMed Central IDPMC3272128
Grant ListUL1 TR000005 / TR / NCATS NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
UL1 RR024153 / RR / NCRR NIH HHS / United States
U01 HD040474 / HD / NICHD NIH HHS / United States
U01 AI068633 / AI / NIAID NIH HHS / United States
UM1 AI068615 / AI / NIAID NIH HHS / United States
P30 MH043520 / MH / NIMH NIH HHS / United States
U01AI068633 / AI / NIAID NIH HHS / United States
P30-MH43520 / MH / NIMH NIH HHS / United States
U01HD040474 / HD / NICHD NIH HHS / United States
U01 AI068615 / AI / NIAID NIH HHS / United States
U01 AI068633-01 / AI / NIAID NIH HHS / United States
U01HD040533 / HD / NICHD NIH HHS / United States
U01AI068615 / AI / NIAID NIH HHS / United States