Clinical trial NCT06126913: HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Hiv
Keywords: community ART delivery
HIV
Antiretroviral therapy
Uganda
refugee
humanitarian
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-11-13
Enrollment: 2720
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

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.

Primary outcomes:
measure: HIV viral suppression at 12 months
timeFrame: 12 months (+/- 2 months)
Secondary outcomes:
measure: HIV viral suppression at 6 months
timeFrame: 6 months (+/- 2 months)
measure: Antiretroviral therapy adherence among those virally unsuppressed at 12 months
timeFrame: 12 months (+/- 2 months)
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Institute, Makerere University
Study officials:
affiliation: University of Washington
name: Kelli N. O'Laughlin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: