Comparison of Visual and Ultraviolet Light Inspection Versus DNA/Protein Biomarkers to Assess Product Adherence With Vaginal Microbicide Applicators

Thurman, Andrea Ries; Jacot, Terry A.; Kimble, Thomas; Mauck, Christine; Nelson, Ashley D.; Schwartz, Jill L.; Doncel, Gustavo F.

doi:10.1097/olq.0000000000000209

Cited by 6 publications

(2 citation statements)

References 13 publications

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“…Drug blood levels or other biomarker testing, in contrast, cannot be reported at an individual level due to blinding. Since the Carraguard trial, more robust technologies using biomarkers are being developed that could eliminate some of the limitations of the original applicator dye-test [27,28].…”

Section: Recommendations For Improving Adherence and Adherence Reportingmentioning

confidence: 99%

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials

et al. 2021

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Low adherence in vaginal microbicide clinical trials for HIV prevention has impeded interpretation of trial results and hindered evaluation of potentially efficacious HIV prevention gels. Understanding the underlying reasons why women join trials and their barriers to product use can support identification of ways to improve adherence and its reporting. Eight focus group discussion workshops were conducted with 46 former microbicide trial participants in Durban, South Africa and Mwanza, Tanzania. Participants provided feedback on why women join trials, the barriers to using study gel and reporting adherence accurately, and how clinical trial design can be improved to support better adherence and its reporting. Women join microbicide trials for a number of important reasons such as healthcare and financial reimbursement. Fear of adverse effects from the investigational product was the most important reason why participants reported not using the gel. The key reason for inaccurate reporting of gel use was fear of removal from the trial. Participants made concrete suggestions for improving microbicide trial design such as applicator use testing and real time feedback, improving education to participants about how trials answer their research questions, and improving transparency and clarity about study procedures. Participants also gave feedback on an innovative trial design with a non-randomised arm. Identifying HIV prevention products for women requires better understanding of the lives of women asked to join these trials, and application of that understanding to microbicide trial design. This study has demonstrated that participants and research teams can work collaboratively to design clinical trials that meet needs of both the research and of participants.

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Section: Recommendations For Improving Adherence and Adherence Reportingmentioning

confidence: 99%

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials

et al. 2021

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“…However, several trials have reported poor adherence and, consequently, low effectiveness [ 2 – 4 ]. Additionally, a significant challenge for the microbicides field is the lack of a real-time, objective method of evaluating adherence to product use and study protocol compliance [ 5 – 10 ]. Many studies have reported on difficulties and challenges in measuring adherence in microbicide trials [ 2 – 4 , 10 – 13 ].…”

Section: Introductionmentioning

confidence: 99%

Rapid measures of user’s adherence to vaginal drug products using attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) and multivariate discriminant techniques

et al. 2018

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BackgroundThe topical HIV prevention (microbicides) field is in acute need of a method to rapidly and objectively measure adherence to product use in clinical trials. Infrared (IR) spectroscopy has been used in many pharmaceutical and forensic applications but has yet to be applied to adherence monitoring. In this study, we report on efforts to test the feasibility of using IR spectroscopy as a means to measure residual active or placebo vaginal product, semen exposure and vaginal insertion from a single swab.MethodsA portable IR spectrometer equipped with diamond attenuated total reflectance (ATR) was used to capture spectra of unused vs. vaginally-used swabs, vaginal swabs containing semen, and vaginal swabs to which either tenofovir-containing or matching placebo products (vaginal gel or insert) were added. Spectral data obtained from swabs placed directly on the spectrometer were divided into calibration and testing sets for developing and validating discriminant models set up to provide yes/no predictions of: vaginal vs. non-vaginal use, presence vs. no presence of each test product, and presence vs. no presence of semen. Further validation of models was performed using vaginal swabs collected from a clinical study evaluating vaginally administered placebo insert formulations.ResultsFor each discriminant model developed to predict vaginal vs. non-vaginal use, presence vs. no presence of each test product, and presence vs. no presence of semen, classified validation samples not included in the model development were correctly identified into their respective classes with minimal prediction error. Clinically obtained vaginal swabs collected 15–60 minutes after placebo insert use were also correctly identified, further validating the models.ConclusionOur findings demonstrate the proof of concept that IR spectroscopy can be a method for rapid detection and characterization of microbicide products and biological fluids present in vaginal swabs. This novel method has potential to support real-time, on-site adherence monitoring in clinical or field settings.

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Measurement of Vaginal Microbicide Adherence Using Visual Inspection as Compared to Ultra Violet Light Assessment of Returned Empty Gel Applicators

et al. 2016

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Accurate and objective measurement of adherence is critical in microbicide trials. We compared two applicator tests: visual inspection of returned empty tenofovir gel applicators (VIREA) and ultraviolet light (UVL) assessment in terms of sensitivity and specificity, and for concordance. Sensitivity and specificity analysis of 24 control applicators (12 known-inserted and 12 sham-inserted) at 4-months after receipt was 75.0 and 66.7 % for VIREA and 83.3 and 91.7 % for UVL, respectively. After an additional 3 months of storage sensitivity and specificity was 100 and 58.3 % for VIREA and 100 and 66.7 % for UVL, respectively. In January 2015, 1316 empty applicators were returned as used by 115 participants enrolled at one site in a randomized controlled trial. Assessment outcomes showed 78.8 % agreement between the techniques. Methods concurred that 22.0 % of the returned empty applicators appeared unused. By UVL assessment, 40.0 % of returned empty applicators had no evidence of vaginal insertion, translating to a potential 28.0 % less product used as compared to that returned as used by women. UVL assessment may be considered a more accurate and less subjective measure of adherence as compared to VIREA.

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Comparison of Visual and Ultraviolet Light Inspection Versus DNA/Protein Biomarkers to Assess Product Adherence With Vaginal Microbicide Applicators

Cited by 6 publications

References 13 publications

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials

Rapid measures of user’s adherence to vaginal drug products using attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) and multivariate discriminant techniques

Measurement of Vaginal Microbicide Adherence Using Visual Inspection as Compared to Ultra Violet Light Assessment of Returned Empty Gel Applicators

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