Abstract

BackgroundHIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia.Methods and findingsTrained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator–FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99–1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86–1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04–1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98–1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92–1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94–1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05–1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing.ConclusionsIn this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high.Trial registrationClinicalTrials.gov NCT02827240

Highlights

  • In this study among female sex worker (FSW) in Zambia, we found that HIV self-testing (HIVST) was acceptable and accessible

  • Achieving high HIV testing coverage is essential for realizing the first step of the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 target of diagnosing 90% of all people living with HIV by 2020 [1]

  • In December 2016, the World Health Organization (WHO) released guidelines related to HIV self-testing (HIVST) [2,3], recommending that HIVST be offered in addition to standard HIV testing services to help achieve realization of this target and as an entry point into HIV prevention services for those testing negative

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Summary

Introduction

Achieving high HIV testing coverage is essential for realizing the first step of the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 target of diagnosing 90% of all people living with HIV by 2020 [1]. In December 2016, the World Health Organization (WHO) released guidelines related to HIV self-testing (HIVST) [2,3], recommending that HIVST be offered in addition to standard HIV testing services to help achieve realization of this target and as an entry point into HIV prevention services for those testing negative. There are limited data on the HIV care continuum for FSWs, available estimates suggest that all indicators are far behind the 90-90-90 targets [13,14,15]. Alternative testing strategies, such as HIVST, may help close the gap between current HIV testing coverage among FSWs and achieving UNAIDS’s first 90% target of diagnosing 90% of all people living with HIV by 2020. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia

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