RecruitingNot ApplicableNCT06126913

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

Sponsor

University of Washington

Enrollment

2,720 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections HIV

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.

Eligibility

Inclusion Criteria7

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.

Exclusion Criteria3

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.

Interventions

OTHERCommunity 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.