Improving mental health care for pregnant women with HIV in Kenya

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

Not applicable Interventional University of Colorado, Denver · NCT06117163

This study is testing a new way to combine mental health support with regular care for pregnant women living with HIV in Kenya to see if it helps them feel better and manage their health.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment900 (estimated)
Ages15 Years and up
SexFemale
SponsorUniversity of Colorado, Denver Academic / other
Locations1 site (Nairobi)
Trial IDNCT06117163 on ClinicalTrials.gov

What this trial studies

This study aims to enhance mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV in Kenya who are experiencing common mental health disorders. It will implement a collaborative care model tailored for these women, integrating mental health services into routine antenatal and HIV care. The study will evaluate the effectiveness of this approach on mental health and HIV care outcomes while engaging key stakeholders to assess scalability and sustainability. The ultimate goal is to achieve optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women living with HIV who are attending antenatal clinics in southwestern Kenya and screening positive for common mental disorders.

Not a fit: Patients with imminent plans of suicide or severe impairments due to severe mental, neurological, or substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve mental health and HIV care outcomes for pregnant women living with HIV.

How similar studies have performed: Other studies have shown success in integrating mental health services into HIV care, but this specific approach is novel in the Kenyan context.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Nairobi

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Human Immunodeficiency VirusMental DisorderHIV transmissionPrevention of Mother to Child TransmissionLinkage to careRetention in careAntiretroviral therapy adherenceInfant Health
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.