title: Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: an interview mode experiment using a placebo gel.
abstract: Misreporting of adherence undermines detection of an association between product use and HIV infection in microbicide trials. This study investigates whether, in a placebo trial, audio computer-assisted self-interviewing (ACASI) produces more accurate reporting of adherence and sexual behavior than a face-to-face interview (FTFI). At three South African clinics, 849 women were enrolled and instructed to use applicators filled with placebo gel; participants were randomly assigned to FTFI or ACASI. Behavioral reports were validated through two biomarkers that detect product usage and unprotected sex. For most behaviors, ACASI generated significantly higher reporting, although differences by interview mode appeared to diminish over time. ACASI participants were more likely to report having had sex without gel, but reported and tested applicators did not indicate greater honesty about gel insertion with ACASI. While comparisons of reported unprotected sex with the validated biomarker revealed more agreement with ACASI than with FTFI, differences were small.
authors.affiliation: Population Council, One Dag Hammarskjold Plaza, New York, NY 10017, USA. bmensch@popcouncil.org
authors.forename: Barbara S
authors.initials: BS
authors.lastname: Mensch
authors.forename: Paul C
authors.initials: PC
authors.lastname: Hewett
authors.forename: Sharon
authors.initials: S
authors.lastname: Abbott
authors.forename: Johanna
authors.initials: J
authors.lastname: Rankin
authors.forename: Sarah
authors.initials: S
authors.lastname: Littlefield
authors.forename: Khatija
authors.initials: K
authors.lastname: Ahmed
authors.forename: Nazira
authors.initials: N
authors.lastname: Cassim
authors.forename: Smruti
authors.initials: S
authors.lastname: Patel
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.forename: Thesla
authors.initials: T
authors.lastname: Palanee
authors.forename: Stan
authors.initials: S
authors.lastname: Mierzwa
authors.forename: Stephanie
authors.initials: S
authors.lastname: Skoler-Karpoff
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D015415:Biomarkers / Q000032:analysis; D003201:Computers; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D007407:Interviews as Topic / Q000379:methods; D010349:Patient Compliance / Q000706:statistics & numerical data; D012309:Risk-Taking; D012650:Self Disclosure; D012647:Self-Assessment; D012725:Sexual Behavior; D012959:Socioeconomic Factors; D013019:South Africa; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D015415:Biomarkers