Evaluating community delivery of HIV treatment for newly diagnosed individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a cluster randomized controlled trial conducted at 12 health centers in refugee settlements in Uganda. It aims to assess the effectiveness of expanding community antiretroviral therapy (ART) delivery to individuals newly diagnosed with HIV, focusing on improving engagement in care and achieving viral suppression. The study leverages a differentiated care model that enhances social support and reduces barriers to accessing treatment. Participants will be monitored for their adherence to treatment and overall health outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Infectious Diseases Institute, Makerere University
  Kampala, Uganda Recruiting

Study contacts

• Principal investigator: Kelli N. O'Laughlin, MD, MPH — University of Washington
• Study coordinator: Layla Anderson
• Email: anderla@uw.edu
• Phone: 206-744-5594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.