Comparison of HIV Risk Behaviors Between Clinical Trials and Observational Cohorts in Uganda
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ORIGINAL PAPER
Comparison of HIV Risk Behaviors Between Clinical Trials and Observational Cohorts in Uganda Andrew Abaasa1,2 · Stephen Nash2 · Yunia Mayanja1 · Matt A. Price3,4 · Patricia E. Fast3,5 · Pontiano Kaleebu1 · Jim Todd2
© The Author(s) 2020
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. Keywords HIV · Risk behavior · Trials · Observational · Cohorts
Introduction According to UNAIDS, 1.8 million new HIV infections occurred globally in 2017, 66% of which were in Sub Saharan Africa (SSA) [1]. Available HIV prevention methods have had limited effect in curbing new HIV infections in SSA because of poor adherence and/or lack of access [2]. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10461-020-02838-w) contains supplementary material, which is available to authorized users. * Andrew Abaasa [email protected]; [email protected]; [email protected] 1
MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda
2
London School of Hygiene and Tropical Medicine, London, UK
3
International AIDS Vaccine Initiative, New York, USA
4
Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, USA
5
Pediatric Infectious Diseases, School of Medicine, Stanford University, Palo Alto, CA, USA
Three possible long-term hopes for controlling the HIV pandemic are an effective and affordable HIV vaccine [3], a long-acting drug [4], and antibody injection [5]. Successful efficacy trials will need populations with high HIV incidence and SSA is likely to be a key destination for many such trials. However, many SSA countries suffer from generalized HIV epidemics [6, 7], and although the HIV incidence is below 1% per annum [8], the HIV prevalence in the general population in Uganda has consistently remained above 5% [1]. In such a setting, trials may not be conducted in the general population but population sub groups. Occupational subpopulations, such as Fisherfolks (FF) and female sex workers (FSW), are suitable for HIV vacci
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