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

Not Applicable

Recruiting

• Conditions: HIV Infections; Hiv
• Interventions: Other: Community Antiretroviral Therapy

• Registration Number: NCT06126913
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Study Start: 2024-01-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2720

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
4. Tested HIV positive in the past 6 months and not already known to be HIV positive.
5. Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.

Inclusion criteria for data abstraction only:

1. Adult ≥18 years of age or mature minors or emancipated minor.
2. Tested HIV positive in the past 6 months and not already known to be HIV positive.

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Exclusion Criteria

1. Pregnant and breastfeeding women.
2. Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
3. Concurrently enrolled in another biomedical clinical trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Antiretroviral Therapy	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.

Primary Outcome Measures

Name	Time	Method
HIV viral suppression at 12 months	12 months (+/- 2 months)	HIV viral suppression is defined as \<1,000 copies/mL

Secondary Outcome Measures

Name	Time	Method
HIV viral suppression at 6 months	6 months (+/- 2 months)	HIV viral suppression is defined as \<1,000 copies/mL
Antiretroviral therapy adherence among those virally unsuppressed at 12 months	12 months (+/- 2 months)	assessed by determining tenofovir diphosphate blood concentrations among those virally unsuppressed

Trial Locations

Locations (1)

Infectious Diseases Institute, Makerere University; 🇺🇬 Kampala, Uganda