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HIV Engagement and Adolescent Depression Support (HEADS-UP)

Study acronym: HEADS-UP
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Results posted: Sep 30, 2026 Primary endpoints revised (5) · Eligibility criteria expanded, about 6 words · Secondary endpoints revised (3) · 1 more Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (3)
    • Publications: details revised at 1 of 1 entry
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Minor Trial status: Recruiting to Completed Enrollment target: estimated 105 to confirmed 106 · Primary and study completion dates changed from estimate of Nov 2025 to Oct 22, 2025 · Site details revised at 5 of 5 sitesv6 Show 3 more changesShow less
    • Enrollment target: estimated 105 to confirmed 106
    • Primary and study completion dates changed from estimate of Nov 2025 to Oct 22, 2025
    • Site details revised at 5 of 5 sites
  4. Notable Primary and study completion dates: Apr 2025 to Nov 2025v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2024 to Jul 6, 2024 · Site details revised at 5 of 5 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2024 to Jul 6, 2024
    • Site details revised at 5 of 5 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Primary and study completion dates: Jun 2024 to Apr 2025 Start date: Jan 2024 to Jul 2024v3 Show 1 more changeShow less
    • Start date: Jan 2024 to Jul 2024
  2. Minor Study description expanded, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.
Trial Details
NCT Number NCT06173544
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: RTI International, National Institute of Mental Health (NIMH)
Conditions Depression, Anxiety, Adolescent Behavior, HIV Infections, Immune System Diseases
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov