title: Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010.
abstract: This study examined study product adherence and its determinants in the Botswana oral pre-exposure prophylaxis efficacy trial. Among the 1,219 participants, the mean adherence by pill count and 3-day self-report was 94 % for each. In multivariable models, pill count adherence was significantly associated with adverse events (nausea, dizziness, vomiting) (RR 0.98 95 % CI 0.98-1.00; p = 0.03) and side effect concerns (RR 0.98 95 % CI 0.96-0.99; p = 0.01). Self-reported adherence was significantly associated with having an HIV-positive partner (RR 1.02 95 % CI 1.00-1.04; p = 0.02) and Francistown residence (RR 0.98 95 % CI 0.96, 0.99; p = 0.0001). Detectable drug concentrations showed modest associations with self-report and pill count adherence, and drug levels were higher among those self-reporting 100 % adherence than those reporting <100 %. Most common adherence barriers involved refill delays and other logistic challenges; cellphone alarm reminder use was the most common facilitator.
authors.affiliation: HIV Prevention Research Unit, CDC Botswana, Gaborone, Botswana, poloko.kebaabetswe@mopipi.ub.bw.
authors.forename: Poloko M
authors.initials: PM
authors.lastname: Kebaabetswe
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Stirratt
authors.forename: Eleanor
authors.initials: E
authors.lastname: McLellan-Lemal
authors.forename: Faith L
authors.initials: FL
authors.lastname: Henderson
authors.forename: Simone C
authors.initials: SC
authors.lastname: Gray
authors.forename: Charles E
authors.initials: CE
authors.lastname: Rose
authors.forename: Tiffany
authors.initials: T
authors.lastname: Williams
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Paxton
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D001902:Botswana; D000068679:Emtricitabine / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D065129:Pre-Exposure Prophylaxis; D057566:Self Report; D011795:Surveys and Questionnaires; D000068698:Tenofovir / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D016903:Drug Monitoring
chemical_list: D019380:Anti-HIV Agents; D000068698:Tenofovir; D000068679:Emtricitabine