Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use

Findings from the Carraguard Phase 3 Trial

Bibliographic Data

ID15334457
AuthorsBarbara Friedland (0000-0002-5041-3634, corresponding author), Marie C D Stoner (0000-0002-7189-8669, Population Council), Marie Stoner, Michelle M Chau (0000-0002-0554-0757, Population Council), Marlena Plagianos (0000-0003-4718-5674, Population Council), Marlena Gehret Plagianos, Sumen Govender, Neetha Morar (0000-0003-2661-3676), Neetha S Morar (South African Medical Research Council), Lydia Altini (University of Cape Town), Stephanie Skoler-Karpoff (Population Council), Khatija Ahmed (0000-0003-0309-1641, Setshaba Research Centre), Gita Ramjee (South African Medical Research Council), Constance Monedi (Setshaba Research Centre), Robin Maguire (Population Council), Pekka Lahteenmaki (University of Helsinki)
Year2015
Volume20
Issue11
Pages2565-2577
Publication date2015-07-23
Open AccessYes
TypeARTICLE
VenueAIDS and Behavior (JOURNAL)
Journal identifiersISSN: 1090-7165 • E-ISSN: 1573-3254
PublisherSpringer Science+Business Media (PUBLISHER • DE)
DOI10.1007/s10461-015-1123-x
PMID26204987
OpenAlexW2128400935
LanguageEN
Citations received2
References cited36

A randomized, placebo-controlled, efficacy trial of Carraguard was unable to demonstrate a reduction in women's risk of HIV infection, which may have been due, in part, to low adherence (gel used in 42 % of vaginal sex acts, on average). A secondary analysis was undertaken to understand baseline factors associated with high adherence (gel used in ≥85 % of sex acts). Women who reported ≥1 vaginal sex act, returned ≥1 opened applicator, and had ≥1 conclusive post-enrollment HIV test (N = 5990) were included. Adherence was estimated as the ratio of average weekly applicator insertions (based on a dye stain assay indicating vaginal insertion)/average weekly sex acts (by self-report). Multivariate logistic regression modeling indicated that coital frequency, site, contraception, and partner age difference had a significant impact on adherence. Women reporting >1 and ≤2 vaginal sex acts per week, on average, were half as likely to be adherent as those reporting 1 vaginal sex act per week or less [adjusted odds ratio (AOR): 0.48; 95 % CI 0.38-0.61]; women from the Western Cape had one-third the odds of being adherent compared to women from KZN (AOR: 0.31; 95 % CI 0.23-0.41); compared to women using injectable contraception, women using any other or no method were more likely to be adherent (AOR: 1.30; 95 % CI 1.04-1.63); and women who had a larger age gap from their partners were more likely to be adherent (AOR: 1.03; 95 % CI 1.01-1.05; p = 0.001). Despite low adherence, overall, 13 % of participants achieved nearly perfect adherence, indicating a potential niche for a coitally dependent microbicide. More research is needed on the impact of sexual patterns and HIV risk perception on product acceptability and adherence to improve counseling in ongoing trials and when products are eventually introduced

Gynecology · Human immunodeficiency virus (HIV · Logistic regression · Microbicide · Obstetrics · Odds · Odds ratio · Placebo · Randomized controlled trial · Adolescent Sexual and Reproductive Health · Demography · HIV, Drug Use, Sexual Risk · HIV/AIDS Research and Interventions · Medicine · Immunology · Internal Medicine

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