RecruitingNot ApplicableNCT06117163

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)

Sponsor

University of Colorado, Denver

Enrollment

900 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Human Immunodeficiency Virus Mental Disorder

Summary

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.

Eligibility

Sex: FEMALEMin Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study (Tunawiri) tests whether an integrated mental health care program can improve outcomes for pregnant women living with HIV in Kenya who are also experiencing common mental health problems like depression or anxiety. HIV and mental health problems frequently co-occur and can affect both maternal and infant health. **You may be eligible if:** - You are a pregnant woman living with HIV - You attend an antenatal clinic in southwestern Kenya - You screened positive for probable depression or another common mental health condition - You live in the area served by the study facility - You are on or starting antiretroviral therapy (ART) - You are 15 years or older **You may NOT be eligible if:** - You have immediate plans for suicide or self-harm - You have a severe mental health condition, severe neurological disorder, or severe substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCollaborative Care Model

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.

Locations(1)

Kenya Medical Research Institute

Nairobi, Kenya

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NCT06117163

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