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Predicting Product Adherence in a Topical Microbicide Safety Trial in Pune, India

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Abstract

The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples’ ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction.

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Acknowledgments

This study was conducted with support from the United States Agency for International Development (USAID) through Cooperative Agreement GPO-A-OO-05-00022-00; however, the views expressed do not necessarily reflect those of USAID.

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Authors and Affiliations

  1. Behavioral and Social Science Research Department, Health & Development Sciences, FHI 360, 2224 East Highway 54, Durham, NC, 27319, USA

    Elizabeth E. Tolley & Sharon Tsui

  2. Indian Council for Medical Research, Chennai, India

    Sanjay Mehendale

  3. University of North Carolina, Chapel Hill, USA

    Mark A. Weaver

  4. National AIDS Research Institute, Pune, India

    Rewa Kohli

Authors
  1. Elizabeth E. Tolley
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  2. Sharon Tsui
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  3. Sanjay Mehendale
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  4. Mark A. Weaver
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  5. Rewa Kohli
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Correspondence to Elizabeth E. Tolley.

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Tolley, E.E., Tsui, S., Mehendale, S. et al. Predicting Product Adherence in a Topical Microbicide Safety Trial in Pune, India. AIDS Behav 16, 1808–1815 (2012). https://doi.org/10.1007/s10461-011-0036-6

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  • DOI: https://doi.org/10.1007/s10461-011-0036-6

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