Date Published: November 21, 2017
Publisher: Public Library of Science
Author(s): Michael M. Chanda, Katrina F. Ortblad, Magdalene Mwale, Steven Chongo, Catherine Kanchele, Nyambe Kamungoma, Andrew Fullem, Caitlin Dunn, Leah G. Barresi, Guy Harling, Till Bärnighausen, Catherine E. Oldenburg, Linda-Gail Bekker
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
Partial Text: 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 . 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. In particular, the guidelines recognize the importance of the development of new approaches such as HIVST for members of key populations that frequently have lower uptake of HIV testing services due to multilevel factors such as healthcare provider stigma [4,5] and lack of legal protection .
Between September 16 and October 12, 2016, 1,280 potential participants were screened and 965 were eligible and enrolled in the study (Fig 1); 160 peer educator–participant groups were randomized to 1 of 3 study arms (mean 6.0 participants per peer educator group, range 4 to 8). Baseline characteristics were similar between the 3 groups (Table 1). A total of 885 (91.7%) of participants returned for follow-up at 1 month, and 898 (93.1%) returned at 4 months, which comprised the analytic population. There was no difference by study arm in follow-up at 1 month (P = 0.35) or 4 months (P = 0.65).
In this study of FSWs in Zambia, a majority of participants at 1- and 4-month assessments reported use of HIV self-tests that were provided either directly via a peer educator or via health clinics or pharmacies. At the 1-month visit, more participants who directly received an HIV self-test reported using the self-test compared to those who had to collect the test from a health facility, and more participants in the delivery arm reported any HIV testing in the previous month compared to the coupon arm. However, there was no difference between the HIVST arms in either measure by the 4-month time point. In the short term, direct delivery of the HIV self-test may be more effective because it removes some barriers to using the self-test—such as concerns related to confidentiality or logistical barriers—that are mitigated over time. In many health systems, the most realistic distribution mechanism for HIV self-tests will be via existing health clinics and pharmacies. Furthermore, in the delivery arm, the test is immediately available, whereas in the coupon arm, there is necessarily a delay in collecting and using the test since the coupon requires participants to take time to visit a health facility and collect the HIV self-test. The results of this study indicate that facility provision is acceptable to FSWs and can lead to uptake of HIVST just as high as through direct delivery within a few months.