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DOI: 10.1101/2022.12.23.22283834

Identifying efficient linkage strategies for HIV self-testing (IDEaL): a study protocol for an individually randomized control trial

K.Dovel K. Balakasi J. Hubbard ...+8 A. T. Choko
Introduction Men in sub-Saharan Africa are less likely than women to initiate antiretroviral therapy (ART) and are more likely to have longer cycles of disengagement from ART programs. Treatment interventions that meet the unique needs of men are needed, but they must be scalable. We will conduct a study to test the impact of various interventions on six-month retention in ART programs among men living with HIV who are not currently engaged in care. Methods and Analysis We will conduct a programmatic, individually randomized, non-blinded, non-inferiority controlled trial. Non-engaged men will be randomized 1:1:1 to either a Stepped, Low-Intensity, or High-Intensity arm. In the Stepped arm, intervention activities build in intensity over time for those who do not reengage in care with the following steps: 1) one-time male-specific counseling + facility navigation; 2) ongoing male mentorship + facility navigation; 3) outside-facility ART initiation + male-specific counseling + facility navigation for follow-up ART visits. The Low-Intensity Intervention includes one-time male-specific counseling + facility navigation only and the High-Intensity Intervention offers immediate outside-facility ART initiation + male-specific counseling + facility navigation for follow-up ART visits. Our primary outcome is 6-month retention in care. Secondary outcomes include cost-effectiveness and rates of adverse events. Ethics and Dissemination The Institutional Review Board of the University of California, Los Angeles and the National Health Sciences Research Council in Malawi have approved the trial protocol. Findings will be disseminated rapidly in national and international forums, as well as in peer-reviewed journals and are expected to provide urgently needed information to other countries and donors.