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Co-enrollment in multiple HIV prevention trials - experiences from the CAPRISA 004 Tenofovir gel trial.

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dc.contributor.authorAbdool Karim, Quarraisha.
dc.contributor.authorKharsany, Ayesha Bibi Mahomed.
dc.contributor.authorNaidoo, Kasavan.
dc.contributor.authorYende Zuma, Nonhlanhla.
dc.contributor.authorGengiah, Tanuja Narayansamy.
dc.contributor.authorOmar, Zaheen.
dc.contributor.authorArulappan, Natasha.
dc.contributor.authorMlisana, Koleka Patience.
dc.contributor.authorLuthuli, Londiwe R.
dc.contributor.authorAbdool Karim, Salim Safurdeen.
dc.date.accessioned2013-07-05T13:10:38Z
dc.date.available2013-07-05T13:10:38Z
dc.date.created2011
dc.date.issued2011
dc.description.abstractBackground—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. Experiences—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 were implemented. Shared electronic database between research units were established to enable verification of each volunteer’s trial participation and to prevent future co-enrollments. Lessons Learnt—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 as the reasons for their enrolment in the CAPRISA 004 trial. Conclusion—Instituting education programs based on the reasons reported by women for seeking enrolment in more than one trial and using a shared central database system to identify co-enrollments have effectively prevented further co-enrollments.en
dc.identifier.citationPublished in final edited form as: Abdool Karim, Q., et al. 2011. Co-enrollment in multiple HIV prevention trials - experiences from the CAPRISA 004 Tenofovir gel trial. Contemp Clin Trials 32 (3) pp. 333–338.en
dc.identifier.issn1551-7144
dc.identifier.urihttp://dx.doi.org/10.1016/j.cct.2011.01.005.en
dc.identifier.urihttp://hdl.handle.net/10413/9260
dc.language.isoenen
dc.publisherElsevier.en
dc.subjectClinical trials--Social aspects.en
dc.subjectAIDS (Disease)--Research.en
dc.subject.otherCAPRISA 004 Tenofovir gel trial.en
dc.subject.otherHIV prevention trials.en
dc.subject.otherCo-enrollment.en
dc.titleCo-enrollment in multiple HIV prevention trials - experiences from the CAPRISA 004 Tenofovir gel trial.en
dc.typePeer reviewed journal articleen

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