Volunteer Factors Related to Discontinuation from the Phase III "Prime-Boost" HIV Vaccine Trial in Mueang District of Rayong Province
Keywords:
phase III, Volunteer discontinuationAbstract
The evaluation of candidate HIV vaccines in phase- trials required high retention rates for optimal evaluation of vaccine efficacy. Mueang district of Rayong Province, one of eight districts participating in the trial, had a high proportion of volunteers who had migrated to work in the province. This study aimed to identify factors related to volunteer discontinuation from the study. There were 3,480 volunteers screened in Mueang district between September 2003 and December 2005. Date of screening, daily number of screened volunteers in the district, birth place, and discontinuation from the study were analyzed. Screening days with more than 13 volunteers at all screening sites was defined as "over-screening". Discontinuation from study included withdrawal, lost to follow up for more than 1 year, or death.It was found that maximum number of monthly screened volunteers was 224 and the minimum was 29. Out of 3,480 HIV-uninfected volunteers, 2,304 (66.2%) were enrolled for vaccination. The discontinuation rate was 4.4% and the rate among volunteers screened on "over-screening" days was not different from the others. While the volunteers with other-province birth place had a higher rate of discontinuation than volunteers born in Rayong (5.8% and 3.0%, RR 1.92, 95%CI 1.28-2.86). No relationship between discontinuation and other demographic characteristics was observed. Therefore, more activities to support high follow-up rates among migratory volunteers were needed. For future studies, recruitment plans focusing on enrolling volunteers who were natives of the province, might help prevent study discontinuation.
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