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

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06126913

Collaborator

National Institute of Mental Health (NIMH) (NIH)

2,720

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hiv	Other: Community Antiretroviral Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2720 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2028

Anticipated Study Completion Date :

Jan 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care At sites randomized to standard care, participants newly diagnosed will receive facility-based care per Uganda Ministry of Health (MoH) protocols
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: Standard of Care

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

Experimental: 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.

Other: Community Antiretroviral Therapy

Outcome Measures

Primary Outcome Measures

HIV viral suppression at 12 months [12 months (+/- 2 months)]
HIV viral suppression is defined as <1,000 copies/mL

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Inclusion criteria for data abstraction only:

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 Criteria:

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.