Document Detail


Feasibility, performance, and acceptability of the Wisebag™ for potential monitoring of daily gel applicator use in Durban, South Africa.
MedLine Citation:
PMID:  23054042     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Ariane van der Straten; Elizabeth Montgomery; Diantha Pillay; Helen Cheng; Anushka Naidoo; Zakhele Cele; Kalendri Naidoo; Miriam Hartmann; Jeanna Piper; Gonasagrie Nair
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  AIDS and behavior     Volume:  17     ISSN:  1573-3254     ISO Abbreviation:  AIDS Behav     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-01     Completed Date:  2013-08-06     Revised Date:  2014-02-04    
Medline Journal Info:
Nlm Unique ID:  9712133     Medline TA:  AIDS Behav     Country:  United States    
Other Details:
Languages:  eng     Pagination:  640-8     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Anti-Infective Agents, Local / administration & dosage*
Double-Blind Method
Drug Monitoring
Equipment Design* / statistics & numerical data
Feasibility Studies
Female
HIV Infections / drug therapy,  epidemiology*,  prevention & control
Humans
Medication Adherence* / statistics & numerical data
Middle Aged
Patient Acceptance of Health Care
Patient Satisfaction
Pilot Projects
Reproducibility of Results
South Africa / epidemiology
Vaginal Creams, Foams, and Jellies / administration & dosage*
Grant Support
ID/Acronym/Agency:
5UM1AI068633/AI/NIAID NIH HHS; UM1 AI068633/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Infective Agents, Local; 0/Vaginal Creams, Foams, and Jellies
Comments/Corrections

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