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

NCT ID: NCT06126913

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2028-01-31

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.

Conditions

HIV Infections; Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard of Care

At sites randomized to standard care, participants newly diagnosed will receive facility-based care per Uganda Ministry of Health (MoH) protocols

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Community Antiretroviral Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

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.

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kelli O'Laughlin

Associate Professor, Departments of Emergency Medicine and Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelli N. O'Laughlin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Infectious Diseases Institute, Makerere University

Kampala, , Uganda

Site Status: RECRUITING

Countries

Uganda

Central Contacts

Layla Anderson

Role: CONTACT

anderla@uw.edu

206-744-5594

Kelli O'Laughlin, MD, MPH

Role: CONTACT

kolaugh@uw.edu

Facility Contacts

Timothy Muwonge

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH130216

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00016473

Identifier Type: -

Identifier Source: org_study_id