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Citation Information

Type Journal Article - Clinical Research in HIV AIDS Prevention
Title Evaluation of recruitment approaches for the HPTN 052 clinical trial of HIV serodiscordant couples in rural western Kenya
Author(s)
Volume 1
Issue 4
URL http://d.researchbib.com/f/2no3OyozSwL2Imp3O1Lv5ipzpinz91pz5uoUZiMT93ozkiLJDhpTujC2McoTH9AmLgG0SDYHc​QHxuOHP1Wp3A1MIOREv5jMTL.pdf
Abstract
Recruitment of couples is important for study success. The multi-centered HPTN 052 clinical trial was designed
to evaluate whether immediate versus delayed use of ART by HIV-infected individuals would reduce transmission
of HIV to their HIV-uninfected partners. The objective of this study was to retrospectively compare several
approaches for community recruitment at our site in Kisumu, Kenya based on a) feedback from recruitment
staff, b) associated cost, and c) number of eligible couples enrolled. A secondary objective was to assess the
discordant couples’ acceptability of the community recruitment approaches relative to the a) main recruitment
venues, b) educational materials, and c) local language best suited for explaining the trial. 241 couples were
screened for eligibility using nine recruitment approaches. We compared the approaches used for the 60 couples
found to be eligible to those used for the 56 ineligible couples for whom that information was available.
Analyses for association were carried out. In-depth interviews were conducted with 20 staff and 29 discordant
couples. Records were kept of the costs associated with each approach. Overall, staff interviews revealed that
acceptability of the approaches was high. Challenges were present with all approaches ranging from one member
of the couple not wanting to reveal their positive HIV status to their partner (Patient Support Center or PSC
approach), to not finding people at home (home based counseling and testing or HBCT approach). The PSC
and the HBCT recruitment approaches were the most effective in terms of recruiting eligible participants. There
was an overall significant difference between the proportion of eligible and ineligible participants among the 9
approaches (χ
2
(8) =33.5; p<0.0001). Analyses for association showed that the PSC approach resulted in attracting
a greater proportion of couples who were eligible than ineligible (χ
2
(1) =6.6; p=0.016). The cost for
the PSC approach was less than one-third that of the HBCT approach. All discordant couples interviewed found
the two main recruitment venues (PSC and their home) acceptable. Among couples who saw the educational
materials, the majority found them useful (poster 72.7%; pamphlet 90.9%; flyer 88.9%). All couples found the
language they were told about the study acceptable. The evaluation of recruitment approaches indicated that
working with local partners, specifically the PSC staff and HBCT staff, was the most effective way to recruit eligible
discordant couples. A focus on collaborations and partnerships between research and clinical organizations
will help study recruitment efforts.

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