Trial reportAIDS and behavior2013
Feasibility, performance, and acceptability of the Wisebag™ for potential monitoring of daily gel applicator use in Durban, South Africa.
Trial report in AIDS and behavior, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Trial
- Scaling up delivery of HIV services in Africa through harnessing trends across global emerging innovations.Frontiers in health services · 2023Review
- Research in the Time of Coronavirus: Continuing Ongoing Studies in the Midst of the COVID-19 Pandemic.AIDS and behavior · 2020Article
- Technical and Psychosocial Challenges of mHealth Usage for Antiretroviral Therapy Adherence Among People Living With HIV in a Resource-Limited Setting: Case Series.JMIR formative research · 2020Article
- Ethical Questions in Medical Electronic Adherence Monitoring.Journal of general internal medicine · 2016Review
- Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.Journal of the International AIDS Society · 2016Review
- Cell Phone-Based and Adherence Device Technologies for HIV Care and Treatment in Resource-Limited Settings: Recent Advances.Current HIV/AIDS reports · 2015Review
- Monitoring microbicide gel use with real-time notification of the container's opening events: results of the CAPRISA Wisebag study.AIDS and behavior · 2014Article
- Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials.Sexually transmitted diseases · 2013Article
- Use of a novel technology to track adherence to product use in a microbicide trial of short duration (MTN-007).AIDS and behavior · 2013Article
- Methodological lessons from clinical trials and the future of microbicide research.Current HIV/AIDS reports · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
The Wisebag™, a lunchbag-style container with an electronic events-monitoring system, was designed as a real-time indirect objective measure of microbicide gel use. Due to cost, alternative functionalities (i.e. use of offline and dummy versions) were explored. We conducted a three-arm, double-blinded pilot study among 50 HIV-negative women in Durban, South Africa to assess participant adherence and Wisebag acceptability and performance. Participants were randomized 2:2:1 to Wisebag with online (events transmitted via cellular signal in real-time), offline (events stored in device memory) or inactive "dummy" devices. Participants were instructed to open the Wisebag daily for 2 weeks, retrieve a study sticker and affix it on a diary card. All participants completed the study. At exit, 94 % did not know which device they had received, nor could they differentiate the Wisebag types when presented with the three options. Five offline devices failed (no data recorded). Per Wisebag events, 26 % of women were perfectly adherent compared to 48 % by self-report and 46 % per diary card. Of reported non-adherence, 92 % did not open the Wisebag (travelling or forgot) and 22 % opened Wisebag >1×/day (curiosity). Participants liked and were comfortable carrying Wisebag. Successful blinding will allow inclusion of offline and/or dummy Wisebags in future study designs. Perfect adherence by opening events was significantly lower than by self-report, highlighting the importance of objective measures of adherence in clinical trials. Additional studies to validate Wisebag data with actual products, with and without SMS and online functionality, in different populations and settings, and in comparison to biomarkers are warranted.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.