Abstract
Many key populations have high-risk behaviors for HIV infection making them suitable for HIV vaccine efficacy trials. However, these behaviors may change when participants enroll into a trial. We used HIV simulated vaccine efficacy trials (SiVETs) nested within observational cohorts of fisherfolks and female sex workers in Uganda to evaluate this difference. We screened observational cohort participants for enrolment into SiVETs, until 572 were enrolled. Those not enrolled (n = 953) continued participation in the observational cohorts. We determined risk behaviors at baseline and at 1 year, assigned a numeric score to each behavior and defined composite score as the sum of reported behaviors. We compared changes in scores over 12 months. Both observational cohorts and SiVETs saw a significant decrease in score but greatest in the SiVETs. Investigators recruiting for trials from these populations should consider the likely effect of reduction in risk behaviors on incident HIV infection and trial statistical power.
Highlights
According to UNAIDS, 1.8 million new HIV infections occurred globally in 2017, 66% of which were in Sub Saharan Africa (SSA) [1]
At the start of the simulated vaccine efficacy trials (SiVETs) period, 1525 (58%) of those enrolled into the original observational cohorts were eligible for screening into SiVETs, 672 (44%) were consecutively screened until 572 (85%) were enrolled
FF population: From the counts and percentages, compared to the non-SiVET1 cohort, the SiVET1 cohort had more men (73% vs 50%), more participants aged 35+ years (25% vs 14%), more participants engaged in fishing or related occupations (59% vs 45%) and more participants who had lived at their current location for more than 1 year (83% vs 70%)
Summary
According to UNAIDS, 1.8 million new HIV infections occurred globally in 2017, 66% of which were in Sub Saharan Africa (SSA) [1]. The follow up schedules and reason (HIV incidence and creating a pool of participants to enroll in future HIV prevention trials) for establishing this cohort were similar to those of OBC1, except that HIV behavioral risk assessment in this cohort was done annually. Details of both cohorts have been previously reported [11, 13, 17, 24, 30]. Details of both SiVETs have been previously reported [9, 13, 30]
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