title: Co-enrollment in multiple HIV prevention trials - experiences from the CAPRISA 004 Tenofovir gel trial.
abstract: BACKGROUND
  In settings where multiple HIV prevention trials are conducted in close proximity, trial participants may attempt to enroll in more than one trial simultaneously. Co-enrollment impacts on participant's safety and validity of trial results. We describe our experience, remedial action taken, inter-organizational collaboration and lessons learnt following the identification of co-enrolled participants.
  
  
  RESULTS
  Between February and April 2008, we identified 185 of the 398 enrolled participants as ineligible. In violation of the study protocol exclusion criteria, there was simultaneous enrollment in another HIV prevention trial (ineligible co-enrolled, n=135), and enrollment of women who had participated in a microbicide trial within the past 12 months (ineligible not co-enrolled, n=50). Following a complete audit of all enrolled participants, ineligible participants were discontinued via study exit visits from trial follow-up. Custom-designed education program on co-enrollment impacting on participants' safety and validity of the trial results was implemented. Shared electronic database between research units was established to enable verification of each volunteer's trial participation and to prevent future co-enrollments.
  
  
  CONCLUSIONS
  Interviews with ineligible enrolled women revealed that high-quality care, financial incentives, altruistic motives, preference for sex with gel, wanting to increase their likelihood of receiving active gel, perceived low risk of discovery and peer pressure are the reasons for their enrollment in the CAPRISA 004 trial.
  
  
  CONCLUSIONS
  Instituting education programs based on the reasons reported by women for seeking enrollment in more than one trial and using a shared central database system to identify co-enrollments have effectively prevented further co-enrollments.
authors.affiliation: Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban, South Africa.
authors.forename: Quarraisha Abdool
authors.initials: QA
authors.lastname: Karim
authors.forename: Ayesha B M
authors.initials: AB
authors.lastname: Kharsany
authors.forename: Kasavan
authors.initials: K
authors.lastname: Naidoo
authors.forename: Nonhlanhla
authors.initials: N
authors.lastname: Yende
authors.forename: Tanuja
authors.initials: T
authors.lastname: Gengiah
authors.forename: Zaheen
authors.initials: Z
authors.lastname: Omar
authors.forename: Natasha
authors.initials: N
authors.lastname: Arulappan
authors.forename: Koleka P
authors.initials: KP
authors.lastname: Mlisana
authors.forename: Londiwe R
authors.initials: LR
authors.lastname: Luthuli
authors.forename: Salim S Abdool
authors.initials: SS
authors.lastname: Karim
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D017954:Africa South of the Sahara; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000592:standards*; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D063065:Organophosphonates / Q000627:therapeutic use*; D010358:Patient Participation; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D057566:Self Report; D000068698:Tenofovir; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D005782:Gels; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine