A randomized trial of index HIV self-testing for sexual partners of ART clients in Malawi
Authors: Dovel Kathryn L , Balakasi Kelvin , Phiri Khumbo , Shaba Frackson , Offorjebe Ogechukwu Agatha , Gupta Sundeep K , Wong Vincent , Lungu Eric , Nichols Brooke E , Nyirenda Mike , Masina Tobias , Worku Anteneh , Hoffman Risa 
Published: September 2022

SummaryBackgroundHIV 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.MethodsWe 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.FindingsA 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.InterpretationIndex 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.FundingUnited States Agency for International Development under cooperative agreement AID-OAA-A-15-00070. KD receives funding from Fogarty International Center K01-TW011484-01.Research in ContextEvidence before this studyIndex partner testing, whereby partners of inidivuals living with HIV are tested for HIV, is a primary entry point to HIV services among higher risk populations in eastern and southern Africa. Yet coverage for index partner testing remains poor. Distance to facilities, fear of unwanted disclosure and lack of privacy, and logistics related to tracing partners in the community are all major barriers to uptake of index partner testing. HIV self-testing is an effective strategy to improve testing coverage, but it has rarely been used in the context of index partner testing. HIVST may allow partners to test where and when they want, and may encourage positive communication within partnerships.Added value of this studyWe present new evidence from a cluster randomized control trial in Malawi that index HIVST among the primary partners of ART clients can dramatically increase uptake of index partner testing, with a 167% increase in testing compared to standard partner referral slips. Very few adverse events were reported in either arm. We also present some of the first data on time to ART initiation after a reactive HIVST kit, and the cost-effectiveness of an HIVST intervention for ART initiation.Implications of all the available evidenceIndex HIVST can increase HIV testing among partners of ART clients without increasing adverse events in Malawi. Importantly, we found that male partenrs were still less likely than female partners to test and initate treatment within the HIVST intervention. Additional interventions to improve linkage to care after using HIVST kits are needed. Index HIVST can be a useful strategy to easily increase testing coverage among higher risk parnters. However, we found that only 9% of ART clients screened had partners who were eligible for index HIVST. This suggests that while index HIVST is effective in the Malawi setting, the intervention’s reach at a national level may be narrow.