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

Last updated: January 7, 2025
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Hiv Infections

Treatment

Community Antiretroviral Therapy

Clinical Study ID

NCT06126913
STUDY00016473
R01MH130216
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating thatthe subject (or a legal representative) has been informed of all pertinent aspectsof 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 aredefined as individuals 14-17 years of age who have drug or alcohol dependency or asexually transmitted infection. Emancipated minors are defined as individuals belowthe age of majority (18 years) who are pregnant, married, have a child, or areself-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

Exclusion Criteria:

  1. Pregnant and breastfeeding women.

  2. Clients deemed by the clinician(s) unfit for community-based care secondary tomedical need.

  3. Concurrently enrolled in another biomedical clinical trial.

Study Design

Total Participants: 2720
Treatment Group(s): 1
Primary Treatment: Community Antiretroviral Therapy
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • Infectious Diseases Institute, Makerere University

    Kampala,
    Uganda

    Active - Recruiting

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