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

ABSTRACT 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 ⟶ 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. ARTICLE SUMMARY Strengths and limitations IDEAL provides male-specific differentiated models of care aimed to improve men’s ART outcomes. We specifically focus on building trusting relationships with health care workers and developing client-led, individualized strategies to overcome barriers to care. IDEAL will test the impact of a stepped intervention for men. This approach promises to improve the efficiency and reach of HIV programs for men as the highest-resource interventions will only be received by the minority of men who are most in need. IDEAL develops and tests male-specific counseling curriculum that, if effective, could easily be taken to scale. Findings from the study will identify critical components for male-specific counseling, especially among men who struggle to be retained in HIV care.