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

Sponsor: University of Colorado, Denver • ClinicalTrials.gov ID: NCT06117163

Registry updated: 2026-10-08

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Description

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.

Interventions

Collaborative Care Model (Behavioral)
The investigators propose a CCM called Tunawiri, meaning "thrive" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression, and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * imminent plans of suicide * severe impairment due to severe mental, neurological or substance use disorders.

Conditions

Human Immunodeficiency Virus Mental Disorder

Locations

Kenya Medical Research Institute — Nairobi, Kenya

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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