HIV care models in Uganda.

BackgroundUntil recently, community-based antiretroviral therapy (ART) delivery was only available for people living with HIV on ART for ≥6 months with a suppressed viral load. However, early attrition from HIV care is common, particularly in refugee settlements where structural and psychosocial barriers to care are pronounced, and reducing barriers to life-saving ART sooner (e.g., at ART initiation) through community-based ART delivery may improve treatment outcomes. The Head StART study will evaluate the effectiveness, implementation, and health system costs of community ART delivery for individuals newly diagnosed with HIV in refugee settlements in Uganda.MethodsIn a cluster randomized trial, twelve health centers in five refugee settlements in Uganda were randomized (1:1) to intervention or standard of care (SoC), with stratification to balance site characteristics. Individuals testing positive for HIV are screened for study eligibility (inclusion criteria: diagnosed with HIV DiscussionThis trial will generate critical effectiveness, implementation, and budget impact data on community ART delivery for individuals newly diagnosed with HIV in refugee settlements needed to optimize HIV care for humanitarian populations.Trial registrationClinicalTrials.gov: NCT06126913. Registered 27 September 2023. https://clinicaltrials.gov/study/NCT06126913