ArticleSexually transmitted diseases2013
Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials.
Article in Sexually transmitted diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- Article
- Vaginal progesterone to prevent preterm delivery among HIV-infected pregnant women in Zambia: A feasibility study.PloS one · 2020Article
- Feasibility and Acceptability of Real-Time Antiretroviral Adherence Monitoring among Depressed Women Living with HIV in the Deep South of the US.AIDS and behavior · 2019Article
- Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol.Pilot and feasibility studies · 2018Article
- Exit interviews administered to patients participating in the COSTOP placebo controlled randomised trial in Uganda.Contemporary clinical trials communications · 2016Article
- Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.Journal of the International AIDS Society · 2016Review
- 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 and behavior · 2014Article
- Article
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Authors and funding
11 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundAccurate measurement of adherence to product use is an ongoing challenge in microbicide trials.
methodsWe compared adherence estimates using 2 applicator tests (a dye stain assay [DSA] and an ultraviolet light assay [UVA]), the Wisebag (an applicator container that electronically tracks container openings), and self-reported adherence (ability, frequency, and percent missed doses). Healthy, HIV-negative, nonpregnant US women aged 23 to 45 years received a Wisebag and 32 applicators filled with placebo gel were instructed to insert 1 applicator daily for 30 days, returned the Wisebag and all applicators, and completed an exit interview. Emptied applicators were tested by UVA and then DSA, and scored by 2 blinded readers. Positive and negative controls were randomly included in applicator batches.
resultsAmong 42 women enrolled, 39 completed the study. Both DSA and UVA yielded similar sensitivity (97% and 95%) and specificity (79% and 79%). Two participants had fully inoperable Wisebags, and 9 had partially inoperable Wisebags. The proportion of participants considered to have high adherence (≥80%) varied: 43% (Wisebag), 46% (UVA), 49% (DSA), and 62% to 82% (self-reports). For estimating high adherence, Wisebag had a sensitivity of 76% (95% confidence interval, 50%-93%) and a specificity of 85% (95% confidence interval, 62%-97%) compared with DSA. Although 28% of participants reported forgetting to open the Wisebag daily, 59% said that it helped them remember gel use.
conclusionsDye stain assay and UVA performed similarly. Compared with these tests, self-reports overestimated and Wisebag underestimated adherence. Although Wisebag may encourage gel use, the applicator tests currently seem more useful for measuring use in clinical trials.
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