A randomized trial of index HIV self-testing for sexual partners of ART clients in Malawi

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. Funding United States Agency for International Development under cooperative agreement AID-OAA-A-15-00070. KD receives funding from Fogarty International Center K01-TW011484-01. Evidence before this study Index 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 study We 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 evidence Index 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT03271307 ### Funding Statement This study was funded by the United States Agency for International Development under cooperative agreement AID-OAA-A-15-00070. KD receives funding from Fogarty International Center K01-TW011484-01. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Malawi National Health Sciences Research Committee (NHSRC) and Institutional Review Board at the University of California Los Angeles (UCLA) USA. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes De-identified human data are available upon request from lead author [Dovel].