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PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru

Study acronym: PASEO
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Sep 29, 2023 to Sep 22, 2023v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Start date: Sep 22, 2023 to Sep 29, 2023
    • Eligibility criteria expanded, about 15 words
    • Site details revised at 4 of 4 sites
    v6
  3. Primary completion date: Jan 2025 to Nov 30, 2026
    • Study completion date: Sep 2026 to Jan 31, 2027
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Jul 2023 to Sep 22, 2023
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Secondary endpoints: details revised at 1 of 10 entriesv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is an evaluation of an intervention (nicknamed "PASEO") that aims to facilitate the transition to adult HIV care for adolescents living with HIV in Lima, Peru. The intervention consists of health systems navigation and accompaniment, monthly check-ins with a lay health worker, enhanced social support provided through peer support groups, education sessions, mental health screening and referral, resolution of acute needs, and individualized adherence support. The study is a two-arm 1:1 randomized evaluation to determine the short- and long-term (i.e., post-intervention) efficacy of the PASEO intervention with regard to retention with viral load suppression as well as other indicators of well-being. The cumulative incidence of unsuccessful transition at 12- and 24-months will be compared. The cost and cost-effectiveness of the study intervention in terms of cost per additional successful transition achieved will be estimated. Data on implementation considerations essential for uptake, sustainability, and successful adoption by the public sector will be provided.
Trial Details
NCT Number NCT05938803
Lead Sponsor Harvard University Faculty of Medicine
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 HIV Infections
Related terms HIV Infections, Psychological Well-Being
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov