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

HIV Infections Clinical Trial

— HeadStART  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126913
• Other study ID #: STUDY00016473
• Secondary ID: R01MH130216
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: January 31, 2028

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Layla Anderson
• Phone: 206-744-5594
• Email: anderla[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2720
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Uganda	Infectious Diseases Institute, Makerere University	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV viral suppression at 12 months	HIV viral suppression is defined as <1,000 copies/mL	12 months (+/- 2 months)
Secondary	HIV viral suppression at 6 months	HIV viral suppression is defined as <1,000 copies/mL	6 months (+/- 2 months)
Secondary	Antiretroviral therapy adherence among those virally unsuppressed at 12 months	assessed by determining tenofovir diphosphate blood concentrations among those virally unsuppressed	12 months (+/- 2 months)