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

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Abstract

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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Acknowledgments

We acknowledge the women who participated in the CAPRISA 008 trial and their commitment to finding an HIV prevention method for women. The CAPRISA 008 trial was supported by the Centre for the AIDS program of Research in South Africa (CAPRISA), the United States Agency for International Development (USAID) through CONRAD (PPA-12-143) (Trial Sponsor), the South African Department of Science and Technology through the Technology Innovation Agency and the MACAIDS Fund through the Tides Foundation (Grant No. TFR11-01545). Support from CONRAD for the product manufacturing and packaging as well as support from Gilead Sciences for the TFV used in the production of gel is gratefully acknowledged. We acknowledge Dr. Sarah Cohen for the loan of the UV light viewing box, Londeka Lucia Zondi for training our assessors in the technique of VIREA, Chanelle Smith for conducting gel assessments, and Peter Upfold for photographing applicators.

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Authors and Affiliations

  1. Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, UKZN, Private bag X7, Congella, 719 Umbilo Road, 2nd Floor, Durban, 4013, South Africa

    Michele Upfold, Anneke Grobler & Leila E. Mansoor

  2. Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal, Durban, South Africa

    Michele Upfold, Fatima Suleman & Leila E. Mansoor

Authors
  1. Michele Upfold
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  2. Anneke Grobler
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  3. Fatima Suleman
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  4. Leila E. Mansoor
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Correspondence to Michele Upfold.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the parent CAPRISA 008 study.

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Upfold, M., Grobler, A., Suleman, F. et al. Measurement of Vaginal Microbicide Adherence Using Visual Inspection as Compared to Ultra Violet Light Assessment of Returned Empty Gel Applicators. AIDS Behav 21, 462–469 (2017). https://doi.org/10.1007/s10461-016-1465-z

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  • DOI: https://doi.org/10.1007/s10461-016-1465-z

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