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

NCT06126913 | Recruiting DMC

• 2 other identifiers: STUDY00016473R01MH130216
• Study Type: interventional
• Target: 2,720
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Hiv

Keywords

community ART delivery; HIV; Antiretroviral therapy; Uganda; refugee; humanitarian

Outcome Measures

Primary Outcomes (1)

• HIV viral suppression at 12 months

  HIV viral suppression is defined as \<1,000 copies/mL

  12 months (+/- 2 months)

Secondary Outcomes (2)

• HIV viral suppression at 6 months

  6 months (+/- 2 months)

• Antiretroviral therapy adherence among those virally unsuppressed at 12 months

  12 months (+/- 2 months)

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Community Antiretroviral Therapy

EXPERIMENTAL

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.

Other: Community Antiretroviral Therapy

Interventions

Community Antiretroviral Therapy 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.

Community Antiretroviral Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• 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.
• Tested HIV positive in the past 6 months and not already known to be HIV positive.
• Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.
• Adult ≥18 years of age or mature minors or emancipated minor.
• Tested HIV positive in the past 6 months and not already known to be HIV positive.

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Infectious Diseases Institute, Makerere University

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Kelli N. O'Laughlin, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Layla Anderson

CONTACT

206-744-5594; anderla@uw.edu

Kelli O'Laughlin, MD, MPH

CONTACT

kolaugh@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Departments of Emergency Medicine and Global Health

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: November 13, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)