Date Published: July 14, 2017
Publisher: Public Library of Science
Author(s): Randy M. Stalter, Jenae Tharaldson, Derek H. Owen, Eunice Okumu, Thomas Moench, Natasha Mack, Elizabeth E. Tolley, Kathleen M. MacQueen, Sten H Vermund.
Results of recent microbicide and pre-exposure prophylaxis clinical trials have shown adherence to be a significant challenge with new HIV prevention technologies. As the vaginal ring containing dapivirine moves into two open label follow-on studies (HOPE/MTN-025 and DREAM) and other antiretroviral-based and multi-purpose prevention technology ring products advance through the development pipeline, there is a need for more accurate and reliable measures of adherence to microbicide ring products. We previously conducted a comprehensive landscape analysis to identify new technologies that could be applied to adherence measurement of vaginal rings containing antiretrovirals. To explore attitudes and perceptions towards the approaches that we identified, we conducted a survey of stakeholders with experience and expertise in microbicide and HIV prevention clinical trials. From May to July 2015 an electronic survey was distributed via email to 894 stakeholders; a total of 206 eligible individuals responded to at least one question and were included in the data analysis. Survey respondents were presented with various objective measures and asked about their perceived acceptability to trial participants, feasibility of implementation by study staff, usefulness for measuring adherence and ethical concerns. Methods that require no additional input from the participant and require no modifications to the existing ring product (i.e., measurement of residual drug or excipient, or a vaginal analyte that enters the ring) were viewed as being more acceptable to trial participants and more feasible to implement in the field. Respondents saw value in using objective measures to provide real-time feedback on adherence. However, approaches that involve unannounced home visits for sample collection or spot checks of ring use, which could provide significant value to adherence feedback efforts, were met with skepticism. Additional research on the acceptability of these methods to potential trial participants and trial staff is recommended.
Results of recent microbicide and pre-exposure prophylaxis (PrEP) clinical trials have shown participant adherence to be a significant challenge with new HIV prevention technologies [1–4]. Low levels of product use of oral and vaginal gel microbicides have largely impeded the ability to measure product efficacy [2, 4]. The use of vaginal rings for sustained delivery of antiretrovirals (ARV) has widely been viewed as a way to overcome adherence challenges shown with oral and vaginal gel products . The recent Phase III trials of the vaginal ring containing the ARV dapivirine, ASPIRE (MTN-020) and The Ring Study (IPM 027), showed modest HIV prevention overall among women using the product [1, 6]. However, low levels of consistent use of the ring was cited as an issue in the trials, particularly among younger women, and subsequent analyses showed no detectable protection in participants with low adherence .
A better understanding of women’s adherence to ARV-based vaginal rings is critical for assessing product effectiveness in future clinical trials. We previously conducted a landscape analysis to identify new and existing technologies that can be applied toward measurement of vaginal ring adherence . With this survey, we aimed to obtain valuable formative information about HIV prevention stakeholders’ views on the implementation of many of the measures identified in this landscape analysis.