title: The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.
abstract: BACKGROUND
  FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use. We conducted a follow-up study with former participants in Bondo, Kenya, and Pretoria, South Africa, to understand factors that had influenced overreporting of adherence and to learn the whereabouts of unused pills.
  
  
  METHODS
  Qualitative, semistructured interviews were conducted with 88 participants, and quantitative, audio computer-assisted self-interviews were conducted with 224 participants. We used thematic analysis and descriptive statistics to analyze the qualitative and quantitative data, respectively.
  
  
  RESULTS
  In audio computer-assisted self-interviews, 31% (n = 70) said they had overreported adherence; the main reason was the belief that nonadherence would result in trial termination (69%, n = 48). A considerable percentage (35%, n = 78) acknowledged discarding unused pills. Few acknowledged giving their pills to someone else (4%, n = 10), and even fewer acknowledged giving them to someone with HIV (2%, n = 5). Many participants in the semistructured interviews said other participants had counted and removed pills from their bottles to appear adherent.
  
  
  CONCLUSIONS
  Despite repeated messages that nonadherence would not upset staff, participants acknowledged several perceived negative consequences of reporting nonadherence, which made it difficult to report accurately. Uneasiness continued in the follow-up study, as many said they had not overreported during the trial. Efforts to improve self-reported measures should include identifying alternative methods for creating supportive environments that allow participants to feel comfortable reporting actual adherence.
authors.affiliation: *Social and Behavioral Health Sciences, FHI 360, Durham, NC; †Setshaba Research Centre, Soshanguve, South Africa; ‡Impact Research and Development Organization, Kisumu, Kenya (Lut Van Damme is now with Bill & Melinda Gates Foundation, Seattle, WA); and §Clinical Science, FHI 260, Durham, NC.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Corneli
authors.forename: Kevin
authors.initials: K
authors.lastname: McKenna
authors.forename: Brian
authors.initials: B
authors.lastname: Perry
authors.forename: Khatija
authors.initials: K
authors.lastname: Ahmed
authors.forename: Kawango
authors.initials: K
authors.lastname: Agot
authors.forename: Fulufhelo
authors.initials: F
authors.lastname: Malamatsho
authors.forename: Joseph
authors.initials: J
authors.lastname: Skhosana
authors.forename: Jacob
authors.initials: J
authors.lastname: Odhiambo
authors.forename: Lut
authors.initials: L
authors.lastname: Van Damme
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000328:Adult; D002986:Clinical Trials as Topic; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007407:Interviews as Topic; D007630:Kenya; D055118:Medication Adherence; D063065:Organophosphonates / Q000008:administration & dosage*; D013019:South Africa; D000068698:Tenofovir; D016896:Treatment Outcome
chemical_list: D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine