HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial

Abstract

Background

HIV 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 findings

Trained 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.

Conclusions

In 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 registration

ClinicalTrials.gov NCT02827240

Abstract

In a cluster-randomized trial done in Zambia, Catherine Oldenburg and colleagues study HIV self-testing for female sex workers.

Author summary

Why was this study done?

• HIV self-testing can be done in the absence of a health provider and may close gaps in the HIV treatment and prevention cascades.

• Female sex workers are at increased risk of HIV acquisition and may particularly benefit from HIV self-testing because it could address some of their specific barriers to HIV testing, e.g., health provider stigma and discrimination, health facility hours, and distance to the health facility.

• How HIV self-tests are delivered to female sex workers may impact the effectiveness of this HIV testing intervention.

What did the researchers do and find?

• We measured the effectiveness of 2 HIV self-testing distribution mechanisms by randomizing 965 female sex workers in 3 Zambian transit towns to (1) direct delivery of an HIV self-test (delivery arm), (2) a coupon for collection of an HIV self-test from a health clinic/pharmacy (coupon arm), and (3) referral to standard-of-care HIV testing and counseling (standard-of-care arm) (all provided by peer educators).

• At the 1-month and 4-month follow-up, overall HIV testing in the previous month was high (1-month: 94.9% delivery arm, 84.4% coupon arm, 88.5% standard-of-care arm), and there were few statistically significant differences across study arms.

• Among participants reporting an HIV-positive test result, linkage to HIV-related care and ART initiation were non-significantly lower among those in the HIV self-testing arms compared to the standard-of-care arm at both time points, although there was limited power to detect differences.

• Three adverse events related to HIV self-testing were reported over the duration of the study, all of which were intimate partner violence.

What do these findings mean?

• HIV self-testing appears safe, acceptable, and accessible among female sex workers in Zambian transit towns.

• HIV self-testing, regardless of the delivery model, may not sustainably increase HIV cascade progression in contexts where overall HIV testing is high.