NCT06126913

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,720 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.

Detailed description

Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uganda, to participate in community ART delivery, clients must be "stable" in care (\> 1 year on ART and viral load \< 1,000 copies/mL). Therefore, persons newly diagnosed with HIV are not eligible for community ART delivery. Community ART delivery may benefit persons newly diagnosed with HIV in refugee settlements by bolstering social support and by bringing ART closer to individuals living in these expansive rural settlements. The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.

Conditions

• HIV Infections
• Hiv

Interventions

Type	Name	Description
OTHER	Community Antiretroviral Therapy	Newly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed.

Timeline

• Start date: 2024-01-15
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2023-11-13
• Last updated: 2025-01-09

Locations

1 site across 1 country: Uganda