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NCT06117163Recruiting

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

Integration of a Collaborative Care Model for Mental Health Services Into HIV Care for Pregnant and Postpartum Women in Kenya (the Tunawiri Study)

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
900 (estimated)
First submitted
30 Oct 2023
Start date
1 Oct 2024
Primary completion date
31 Jul 2027
Lead sponsor
University of Colorado, Denver
Diseases
HIV
NCT number
NCT06117163

What you commit to

  • Study type: Interventional
  • Planned participants: 900
  • From 1 Oct 2024 to the primary completion date, 31 Jul 2027
  • 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 illness

  • severe impairment due to severe mental, neurological or substance use disorders.

Other

  • imminent plans of suicide

Who the study is looking for

  • pregnant woman living with HIV attending an antenatal clinic in southwestern Kenya
  • screening positive for probable common mental disorders
  • living in catchment area of study facility.
  • on/initiating ART
  • \>15 years of age

Age in the registry: 15 years to - · Sex: Female · 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
Kenya Medical Research Institute
Coordinator of this site? Confirm its status
NairobiKenyaRecruiting

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