An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India.

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 self-reported 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.