The impact of peer educators on human immunodeficiency viruses (HIV) testing, treatment linkage and viral suppression

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Background: This trial describes a cluster randomized trial designed to evaluate the acceptability and effectiveness of a new intervention program called teach-test-link-trace (TTLT) model. TTLT model is a new program in which peer educators counsel about HIV (teach), perform HIV testing (test) through pinprick house-to-house HIV testing (H2H) or OralQuick HIV self-testing (HIVST), link HIV positive patients to HIV care (link) and trace lost patients house-to-house (trace). Methods: The TTLT model is a 4-arm cluster randomized trial to be conducted in 40 villages in Sidama, SouthEthiopia. The trial has five phases as follows: Phase 1 will assess the acceptability of the TTLT model using a cross-sectional survey. We will measure acceptability from participants using Sekhon and colleagues’ theoretical framework of acceptability of healthcare interventions. Phase 2 will assess effectiveness of the TTLT model through comparing intervention and control groups. For baseline data, we assess the proportion of individuals who self-report to know their HIV status. The intervention groups will receive one of the three home-based interventions provided by peer educators: (i) demonstrate and distribute OralQuick HIV self-testing kits (HIVST), (ii) perform pinprick HIV testing (H2H), and (iii) offer participants a choice to either receive HIVST or H2H. The peer educators will refer all individuals of the three intervention groups to nearby health facilities for confirmatory test if the test result is positive. Peer educators will also conduct a follow up as part of the intervention (at 0, 3 and 6 months after of the antiretroviral therapy) to those who will be diagnosed with HIV through HIVST or H2H and linked with HIV care. The control group will receive the standard care in which nurses counsel and refer eligible household members to nearby health facilities to access existing HIV testing services. The primary outcomes of the interventions are proportion of individuals who know of their HIV status (first 90), link to HIV care and treatment (second 90) and meet virological suppression (third 90). We will perform process evaluation of the trial through qualitative interviews in phase 3, economic evaluation for cost-effectiveness analysis in phase 4, and a sustainability exit strategy using nominal group technique in phase 5. To analyse the quantitative studies, we will apply descriptive and inferential statistical analyses, and qualitative studies will employ thematic framework and content analyses. Ethics approvals will be sought from Flinders University of South Australia and Mekelle University of Northern Ethiopia. The registration for the trial is the intervention phase.