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Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from University of Colorado, Denver

Record History

  1. Primary endpoint(s) modified Eligibility criteria expanded, about 7 words · Secondary endpoints revised (4) Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (4)
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 1, 2024 to Oct 1, 2024 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2024 to Oct 1, 2024
    • Site details revised
  4. Start date: Jan 4, 2024 to Jun 1, 2024v5
  5. Start date: Dec 1, 2023 to Jan 4, 2024v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Nov 1, 2023 to Dec 1, 2023v3
  2. Study description expanded, about 11 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on participants' mental health, antenatal, and HIV care outcomes. The investigators will actively engage key stakeholders throughout the process and assess scalability and sustainability through multi-method approaches. This study will contribute to the overall goal of achieving optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.
Trial Details
NCT Number NCT06117163
Lead Sponsor University of Colorado, Denver
Collaborators: University of North Carolina, Chapel Hill, Kenya Medical Research Institute, University of Alabama at Birmingham
Conditions Human Immunodeficiency Virus, Mental Disorder
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov