title: Adherence in the CAPRISA 004 tenofovir gel microbicide trial.
abstract: High adherence is key to microbicide effectiveness. Here we provide a description of adherence interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir gel trial. Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit. This initially comprised individual counselling and was replaced midway by a structured theory-based adherence support program (ASP) based on motivational interviewing. The 889 women were followed for an average of 18 months and attended a total of 17,031 monthly visits. On average women reported five sex acts and returned 5.9 empty applicators per month. The adherence rate based on applicator count in relation to all reported sex acts was 72.2 % compared to the 82.0 % self-reported adherence during the last sex act. Adherence support activities, which achieve levels of adherence similar to or better than those achieved by the CAPRISA 004 ASP, will be critical to the success of future microbicide trials.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, 2nd Floor, Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7, Congella, 4013, South Africa, mansoor@ukzn.ac.za.
authors.forename: Leila Essop
authors.initials: LE
authors.lastname: Mansoor
authors.forename: Quarraisha
authors.initials: Q
authors.lastname: Abdool Karim
authors.forename: Nonhlanhla
authors.initials: N
authors.lastname: Yende-Zuma
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: MacQueen
authors.forename: Cheryl
authors.initials: C
authors.lastname: Baxter
authors.forename: Bernadette T
authors.initials: BT
authors.lastname: Madlala
authors.forename: Anneke
authors.initials: A
authors.lastname: Grobler
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000282:Administration, Intravaginal; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000008:administration & dosage; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D055118:Medication Adherence; D062405:Motivational Interviewing; D063065:Organophosphonates / Q000008:administration & dosage*; D012424:Rural Population / Q000706:statistics & numerical data; D012725:Sexual Behavior / Q000706:statistics & numerical data; D012959:Socioeconomic Factors; D013019:South Africa / Q000453:epidemiology; D000068698:Tenofovir; D016896:Treatment Outcome; D014505:Urban Population / Q000706:statistics & numerical data
chemical_list: D019380:Anti-HIV Agents; D000891:Anti-Infective Agents, Local; D005782:Gels; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine