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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Uganda
Infectious Diseases Institute, Makerere University
RECRUITING
Kampala
Contact Information
Primary
Layla Anderson
anderla@uw.edu
206-744-5594
Backup
Kelli O'Laughlin, MD, MPH
kolaugh@uw.edu
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 2720
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of Washington

This content was sourced from clinicaltrials.gov