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NCT06126913Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
2720 (estimated)
First submitted
27 Sept 2023
Start date
15 Jan 2024
Primary completion date
31 Jan 2028
Lead sponsor
University of Washington
Diseases
HIV
NCT number
NCT06126913

What you commit to

  • Study type: Interventional
  • Planned participants: 2720
  • From 15 Jan 2024 to the primary completion date, 31 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Infectious Diseases Institute, Makerere University
Coordinator of this site? Confirm its status		KampalaUgandaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.