title: Predicting product adherence in a topical microbicide safety trial in Pune, India.
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.
authors.affiliation: Behavioral and Social Science Research Department, Health & Development Sciences, 2224 East Highway 54, Durham, NC 27319, USA. btolley@fhi360.org
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Tolley
authors.forename: Sharon
authors.initials: S
authors.lastname: Tsui
authors.forename: Sanjay
authors.initials: S
authors.lastname: Mehendale
authors.forename: Mark A
authors.initials: MA
authors.lastname: Weaver
authors.forename: Rewa
authors.initials: R
authors.lastname: Kohli
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000009:adverse effects*; D017280:Condoms / Q000706:statistics & numerical data*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007194:India; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D040242:Risk Reduction Behavior; D012747:Sexual Partners; D012944:Social Support; D012959:Socioeconomic Factors; D000068698:Tenofovir; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D000890:Anti-Infective Agents; D000891:Anti-Infective Agents, Local; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine