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Assessment of adherence to product dosing in a pilot microbicide study
Kathleen Hogarty1, Andrea Kasowitz, Betsy C Herold
1Department of Medicine, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1090, New York, NY 10029, USA.
Objectives:
To determine whether applicator staining could be incorporated into a microbicide study as a marker of adherence.
Goal:
To test whether observers could identify intravaginally inserted applicators and compare the observers' ratings to subjects' self reports.
Study Design:
Subjects participating in a 14-day microbicide trial to assess the safety of 0.5% PRO 2000 or matched placebo gel returned used and unused applicators. Each applicator was individually dyed or batched and immersed in a 0.4% trypan blue waterbath. Masked observers rated the applicators as intravaginally inserted or not; results were compared to subjects' self-reports. To determine if the dye would allow observers to differentiate whether applicators had been filled before intravaginal insertion, staff either filled applicators and discarded gel ex vivo or asked volunteers to intravaginally insert applicators without gel and mixed these with a random sampling of used and unused study samples.
Results:
358 of 360 applicators were returned; 306 were reported to have been vaginally inserted and 52 unused. Observers agreed with the participant's self reports in 98-99% of cases. No differences were observed between applicators stained individually or in batches. The ability to distinguish between applicators that were presumed to have been used properly, intravaginally inserted without gel, filled with gel and emptied ex vivo, or unused ranged from 76 to 87%.
Conclusions:
Staining of applicators is accurate, inexpensive, and correlated well with self-report in a study of short duration. This method could prove useful in assessing adherence to product dosing in future microbicide trials.
Insights
Applicator staining accurately and affordably tracks adherence in microbicide studies, correlating well with self-reports. This method can improve future adherence assessments for microbicide product dosing.
Area of Science:
- Reproductive Health
- Clinical Trials
- Pharmaceutical Sciences
Background:
- Assessing adherence to microbicide products is crucial for trial efficacy.
- Traditional adherence measures like self-reporting can be unreliable.
Purpose of the Study:
- To evaluate applicator staining as a reliable adherence marker in microbicide studies.
- To compare observer assessments of stained applicators with participant self-reports.
Main Methods:
- Subjects in a 14-day microbicide trial returned used and unused applicators.
- Applicators were stained with trypan blue, and observers assessed their use.
- Observer ratings were compared against participant self-reports.
Main Results:
- Applicator staining showed high agreement (98-99%) with participant self-reports.
- The method accurately distinguished between various applicator usage scenarios (76-87%).
- No significant differences were found between individual or batch staining methods.
Conclusions:
- Applicator staining is an accurate, cost-effective method for assessing adherence in short-term microbicide trials.
- This technique offers a valuable tool for improving adherence monitoring in future microbicide research.
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