Background: HIV testing among the sexual partners of HIV-positive clients is critical for case identification and reduced transmission. Current strategies have limited reach. We evaluated an index HIV self-testing (HIVST) intervention among ART clients in Malawi, whereby clients were asked to distribute HIVST kits to their primary sexual partners.
Methods: We conducted an individually randomized, unblinded trial at 3 district hospitals in Malawi between March 28 2018-January 5, 2020. Clients attending ART clinics were randomized 1:2.5 to: (1) standard partner referral slip (PRS); or (2) index HIVST. Inclusion criteria were: ART client is ≥15 years of age; primary partner with unknown HIV status; no history of interpersonal violence with that partner; and partner lives in facility catchment area. The primary outcome was completion of index partner testing, and, if positive, index partner ART initiation within 12-months. Baseline and follow-up surveys with ART clients measured the primary outcome and medical chart reviews measured ART initiation. Uni- and multivariate logistic regressions were conducted.
Findings: A total of 4,043 ART clients were screened and 456 were eligible and enrolled. 365 completed a follow-up survey and were included in the final analysis (22% men). Testing coverage among partners was 71% in the HIVST arm and 25% in PRS (AOR:9.6; 95% CI: 6.45-12.82). HIV positivity rates did not differ by arm (19% in HIVST versus 16% in PRS; p=0.74). ART initiation at 12-months was 46% (14/30) in HIVST versus 75% (3/4) in PRS arms; however, HIVST still resulted in a 94% increase in the proportion of all partners initiating ART due to high testing rates. Adverse events did not vary by arm.
Interpretation: Index HIVST significantly increased HIV testing and ART initiation among ART clients' sexual partners without increased risk of adverse events. Additional research is needed to understand and improve ART initiation within index HIVST.