An Evaluation of Methods to Improve the Reporting of Adherence in a Placebo Gel Trial in Andhra Pradesh, India
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ORIGINAL PAPER
An Evaluation of Methods to Improve the Reporting of Adherence in a Placebo Gel Trial in Andhra Pradesh, India Sharon A. Abbott • Barbara A. Friedland • Avina Sarna • Lauren L. Katzen Ulrike Rawiel • Aylur K. Srikrishnan • C. S. Shalini • Waimar Tun • Christine A. Kelly • Suniti Solomon • Barbara S. Mensch
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Published online: 9 January 2013 Ó Springer Science+Business Media New York 2013
Abstract Female sex workers (FSWs) were recruited for a 4-month placebo vaginal gel trial in Nellore, India. Two experiments explored if prior knowledge of biomarkers for unprotected sex and insertion of gel applicators would yield more accurate self-reports. A third experiment compared self-reports of gel use and adherence levels between FSWs randomly assigned to interactive voice response survey (IVRS) and those assigned to paper diaries. Prior knowledge of biomarkers did not improve accuracy of selfreported condom or gel use, nor did it affect actual adherence. Of those who tested positive for the presence of semenogelin in the vagina, 76 % reported no unprotected sex in the previous 48 h. Overall, women reported using gel on 90 % of days whereas the biomarker indicated gel use on fewer than 50 % of days. Compliance to IVRS was low, despite familiarity with mobile phone technology. Additional explorations with other populations are needed.
S. A. Abbott B. A. Friedland L. L. Katzen U. Rawiel C. A. Kelly B. S. Mensch Population Council, New York, NY, USA S. A. Abbott (&) 41 Underhill Ave., Apt. 1B, Brooklyn, NY 11238, USA e-mail: [email protected] A. Sarna Population Council, New Delhi, India A. K. Srikrishnan C. S. Shalini S. Solomon YRG Care, Chennai, India W. Tun Population Council, Washington, DC, USA
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Keywords Female sex workers India Biomarkers Adherence Clinical Trials Microbicides Interactive voice response survey (IVRS)
Introduction Vaginal microbicides are being developed as female-initiated products to prevent male-to-female transmission of HIV and other sexually transmitted infections (STIs) [1, 2]. One of the key challenges in microbicide trials is obtaining accurate self-reports from participants about product use and sexual behavior. The overreporting of microbicide use and underreporting of unprotected sex have serious consequences for determining efficacy; scientists may conclude that a candidate microbicide is ineffective when in fact low adherence is at fault [3, 4]. Methodological challenges to assessing adherence have been written about extensively in the literature on patients’ drug-taking behaviors and compliance in clinical trials [5–10]. Participants may feel uncomfortable admitting to study staff that they have not used the study product as directed. Additionally, requirements for clinical trial participation, specifically in relation to product and condom use, may disrupt interpersonal relationships and/or challenge existing gender norms, making strict adherence difficult [11, 12]. Accurately recalling product use and/or risk behaviors may also prove
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