PROJECT SUMMARY Despite freely available HIV services and antiretroviral therapy (ART), people newly diagnosed with HIV in refugee settlements in Uganda have suboptimal rates of ART initiation, adherence, and viral suppression. Refugees face unique barriers to HIV care engagement including long distances to clinic with environmental conditions impacting travel, prohibitive transportation costs with severely limited livelihood opportunities to offset them, disrupted social networks, and guarded HIV status disclosure due to fear of anticipated stigma and reliance on other community members to meet basic survival needs. Innovative strategies to improve engagement in HIV care for this priority population are urgently needed. Community ART delivery, a differentiated ART delivery strategy offered in Uganda for stable clients, reduces time and transportation barriers, fosters social support, and improves engagement in HIV care. Individuals newly diagnosed with HIV, however, are currently excluded from participation in community ART delivery and the impact of this ART delivery strategy has not been evaluated for this group. This is a critical gap in HIV research as the time following initial HIV diagnosis is a vulnerable period with high rates of attrition from care. Preliminary findings from a pilot study in Nakivale Refugee Settlement in southwestern Uganda found that early community ART delivery, implemented at the time of HIV diagnosis, may enhance viral suppression in this setting. The overall objective of this proposal is to conduct a cluster randomized controlled trial to discern the effectiveness of “Head StART,” community ART delivery for those newly diagnosed with HIV, compared to standard care (facility-based ART delivery) to achieve HIV viral suppression. The central hypothesis is that Head StART will be an effective and affordable intervention at refugee health centers across Uganda. Guided by promising preliminary data and supported by the social ecological model, this hypothesis will be tested with these specific aims: 1) To evaluate the effectiveness of Head StART in achieving HIV viral suppression for people newly diagnosed with HIV in refugee settlements in Uganda; 2) To assess Head StART implementation across refugee settlement locations to understand the impact of contextual factors on achieving optimal HIV clinical outcomes; and 3) To estimate the programmatic cost and budget impact of implementing Head StART in refugee settlements in Uganda. The approach is innovative, in that it assesses novel timing of community ART delivery in a humanitarian crisis affected population at high risk of poor clinical outcomes. This proposal is responsive to the NIH priorities for HIV-related research in that it includes assessment of HIV viral suppression among refugees and Ugandan nationals newly diagnosed with HIV, as well as evaluation of an intervention to advance ART delivery. The long-term goal is to devise strategies to optimize HIV outcomes in refugee settlements in Uganda. The proposed research is significant, because it could improve HIV viral suppression in humanitarian contexts globally, advancing progress towards the 95-95-95 UNAIDS targets.

PROJECT NARRATIVE The proposed research will evaluate the effect on HIV viral suppression of expanding community ART delivery to individuals newly diagnosed with HIV through the Head StART intervention in refugee settlements in Uganda. We will use the RE-AIM implementation science framework to evaluate the Reach, Effectiveness, Adoption, Implementation, and Maintenance of Head StART across study sites, and conduct a cost and budget impact analysis of the intervention. The project is responsive to PA-20-144 aims of improving HIV treatment outcomes and its results will provide crucial evidence for policymakers regarding effective, feasible, and low-cost strategies to strengthen the HIV care cascade among refugees.