Barcelona 2013
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| Abstract #114 - Adherence | ||||
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Session: 13.3: Adherence (Parallel) on Monday @ 14.30-16.00 in Teatre Chaired by Imma Serra, Stuart Gibson Authors: Presenting Author: Dr Ariane van der Straten - RTI International, United States |
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| Additional Authors: Dr. Jorge Galindo-Sainz, | ||||
| Aim: Self-reports of adherence to microbicides have been unreliable in clinical trials. We evaluated the feasibility and acceptability of the Wisebag? electronic monitoring device for measuring adherence to daily vaginal gel use. We assessed adherence estimates from the Wisebag, which generates a signal, or ?opening event? when opened, compared to two objective measures of applicator insertion: the Dye Stain Assay (DSA) and the UV light test (UV), and to self-report. | ||||
| Method / Issue: Healthy HIV-negative, non-pregnant women aged 23-45 from the Bronx, NY were given a Wisebag and 32 Microlax®-type applicators filled with hydroxyethylcellulose (HEC) placebo gel and instructed to insert one applicator per day for 30 days. At enrollment, participants generated the first Wisebag opening event to retrieve an applicator, which was inserted under clinical supervision (positive controls). At exit, participants returned the Wisebag and all applicators, and completed an interview about Wisebag and gel use, including two measures of adherence: a 6-point scale rating the ability to insert gel as instructed, and a count of days with missed doses. Returned empty applicators were batched and tested for vaginal insertion by UV then DSA. | ||||
| Results / Comments: Of 42 women enrolled, 39 completed the study. Two participants had fully inoperable Wisebag devices and nine had partially inoperable devices, due to battery malfunction. DSA and UV yielded similar sensitivity (97%; 94%) and specificity (79%; 79%) based on control applicators. At study exit, most (96%) applicators were returned; of those returned empty (75%), 90% were positive for insertion per DSA (88% per UV). Median adherence over 30 days varied between 67% (Wisebag), 77% (DSA and UV); 80% (rating scale) and 90% (missed doses); all measures were significantly correlated (p<0.01). Although 28% of participants reported that it was difficult to remember to open the Wisebag daily, 59% said the Wisebag helped them remember to use the gel by acting as a visual reminder. The three most frequent reasons for not opening the Wisebag were: forgetting (54%); travelling (33%) and not being at home (21%). Ten percent reported opening the Wisebag without retrieving an applicator, 15% reported retrieving more than one applicator at a time, because they could not or did not want to carry the Wisebag with them; 18% said they could not use Wisebag in a future microbicide study, mostly because it was impractical or bulky. The cost per participant in materials/supplies for this study was estimated at ~$177 for Wisebag, ~$14 for UV and ~$5 for DSA. | ||||
| Discussion: The Wisebag provided the lowest estimates of adherence and self-reports the highest. The rating scale had the closest adherence estimate compared to the applicator tests. While Wisebag served as a reminder cue, its bulkiness and low portability were problems to users. Different container designs may help address these issues. Further testing of Wisebag or similar monitoring systems is warranted for their potential to enhance product adherence, however, given the current technical difficulties and expense of the Wisebag, applicator tests may prove more feasible as objective adherence measures in microbicide gel clinical trials. | ||||
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