Peer-led HIV care and the UNAIDS 90-90-90 treatment targets in Tigrai, Ethiopia: a cluster randomised trial and economic evaluation of teach-test-link-trace model (TTLT) trial protocol

INTRODUCTION: This study will evaluate the acceptability and effectiveness of a new intervention programme called teach-test-link-trace (TTLT) model in Tigrai, Ethiopia, where peer educators counsel about HIV (teach), perform house-to-house HIV testing (test) through pinprick HIV testing (H2H) or OraQuick HIV self-testing (HIVST), link HIV-positive patients to HIV care (link) and trace lost patients house-to-house (trace). METHODS AND ANALYSIS: The four-arm cluster randomised trial will be conducted in five phases: Phase 1 will assess the acceptability of the TTLT model using a cross-sectional survey among adults aged 18 years irrespective of HIV status in 6909 households from 40 villages (kebeles). Phase 2 will assess effectiveness of the TTLT model through comparing intervention and control groups among HIV negative or unknown HIV status. The intervention groups will receive one of the three home-based interventions provided by peer educators: (1) demonstrate and distribute OraQuick HIV self-testing kits (HIVST), (2) perform pinprick HIV testing (H2H) and (3) offer a choice to either receive HIVST or H2H. 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 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. We will apply descriptive and inferential statistics for quantitative studies, and thematic framework analysis for qualitative studies. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Southern Adelaide Clinical Health Research Ethics Committee (SAC HREC), South Australia, and findings will be disseminated through publications, conference presentations, media release and policy briefs. TRIAL REGISTRATION NUMBER: ACTRN12620000570987p.