# Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2024 · $647,813

## Abstract

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
...

## Key facts

- **NIH application ID:** 10818407
- **Project number:** 5R01MH130216-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Kelli Nicole O'Laughlin
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $647,813
- **Award type:** 5
- **Project period:** 2023-04-01 → 2028-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10818407

## Citation

> US National Institutes of Health, RePORTER application 10818407, Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV (5R01MH130216-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10818407. Licensed CC0.

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