title: No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial.
abstract: BACKGROUND
  Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials.
  
  
  METHODS
  Qualitative research was conducted in Madagascar, South Africa, and the United States to explore the acceptability of three potential true contraceptive efficacy study designs and the feasibility of recruitment for such trials, including characteristics of potential participants who may be willing to join.
  
  
  RESULTS
  Participants preferred the study design with the least restrictive sex criteria: participants have sex with assigned contraceptive method/no method on days around ovulation and use condoms on other days. Participants suggested that condom adherence would be low. Differences were noted across sites on whether female participants should be actively seeking pregnancy or not actively seeking pregnancy but willing to accept a pregnancy. Recruitment of participants was expected to be difficult.
  
  
  CONCLUSIONS
  Data suggest that a true contraceptive efficacy clinical trial may not be feasible at this time in these settings.
authors: FHI 360, Behavioral and Social Sciences, Durham, NC 27713, USA. acorneli@fhi360.org
authors: Amy L
authors: AL
authors: Corneli
authors: Christina
authors: C
authors: Wong
authors: Natalie T
authors: NT
authors: Eley
authors: Monique Peloquin
authors: MP
authors: Mueller
authors: Ny Lovaniaina
authors: NL
authors: Rabenja
authors: Ntsiki
authors: N
authors: Manzini
authors: Teri
authors: T
authors: Swezey
authors: Kathleen Van
authors: KV
authors: Damme
authors: Jenni
authors: J
authors: Smit
authors: Frieda
authors: F
authors: Behets
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D003270:Contraceptive Agents; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D033182:Intention; D008270:Madagascar; D008297:Male; D010342:Patient Acceptance of Health Care; D011247:Pregnancy; D012107:Research Design; D012725:Sexual Behavior; D013019:South Africa; D014481:United States
chemical_list: D003270:Contraceptive Agents