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Barbara
Friedland,
Stephanie Skoler,
Alana de Kock, Lauren Katzen, Nela Williams, Vuyelwa
Mehlomakulu, Vuyelwa Mtimkulu, and Sharon Abbott. "Evaluation of a video to enhance the
informed consent process in a Phase 3 trial of the microbicide
Carraguard® in preventing HIV seroconversion in women." (Poster
no. B40)
ABSTRACT
Background
A 20-minute video was produced for the Population Council’s
Phase 3 efficacy trial of the microbicide Carraguard. 6,203 women
were enrolled at three sites in South Africa, two of which
participated in an evaluation of the video: the University of Cape
Town (UCT) and the University of Limpopo/Medunsa campus (Medunsa).
Methods
Using a pre/post-test design, 400 women (200 per site) were
randomly assigned to recruitment sessions with or without the video.
Interviews were conducted in 2005 using a questionnaire with 13
questions to assess whether the video (in addition to a booklet and
the informed consent form) significantly improved comprehension of
key aspects of the trial. A similar questionnaire was administered
to assess overall comprehension among 300 women (150 per site)
enrolled in the trial.
Results
In the recruitment population, the mean endline score was 59
percent
overall, a 33-point improvement from baseline, with slightly higher
scores in the video group (61%) than the no-video group (57%). The
improvement significantly differed between sites, with a mean score
of 52 percent at UCT and 66 percent at Medunsa (p<.05). In the enrolled
population, the mean score was 70 percent, with a significant difference
(p<.05) between UCT (61%) and Medunsa (78%).
Conclusion
The comprehension level in the video group was not significantly
higher than in the no-video group, however, the video recruitment
sessions were much shorter, a critical factor in complex clinical
trials. The relatively high comprehension levels in the enrolled
population indicate the success of the overall informed consent
process, with the mean score of 70 percent exceeding the 60 percent score required
at enrollment. The significant differences between the two sites
highlight the need for ongoing training and monitoring, despite
standardization of materials and procedures. A qualitative
assessment is currently underway.
3rd South African AIDS Conference Web site
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