What this Trial Is About

Researchers are evaluating the effectiveness of expanding community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in refugee settlements in Uganda. This cluster randomized controlled trial is conducted at 12 health centers and aims to see if community ART can improve HIV viral suppression by reducing barriers such as travel time and increasing social support. Currently, community ART delivery in Uganda is limited to individuals stable in care, but this study focuses on those diagnosed within the past 6 months who are not yet eligible under existing guidelines. Participants at intervention sites who were diagnosed with HIV in the prior 6 months will be offered community ART delivery on a rolling basis during enrollment. They will join existing community ART groups or form new groups based on size and location, bringing treatment closer to their homes. This approach seeks to provide easier access to ART and foster social support among newly diagnosed individuals living in rural refugee settlements. Throughout the study, participants will be monitored for HIV viral suppression at 12 months, with a window of plus or minus 2 months. Researchers will assess engagement in HIV care, adherence to treatment, and viral load outcomes. Participants must be able to communicate in one of five study languages and comply with scheduled visits and procedures. The total follow-up duration includes the initial year after diagnosis, with ongoing support provided through community ART groups.

HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV