Improving mental health care for pregnant women with HIV in Kenya
Official title: Integration of a Collaborative Care Model for Mental Health Services Into HIV Care for Pregnant and Postpartum Women in Kenya (the Tunawiri Study)
Run by University of Colorado, Denver · NCT06117163 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 15 Years and up |
| Sex | Women only |
| Enrollment | 900 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Nairobi) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | July 31, 2027 |
| Study ends | May 31, 2028 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT06117163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in integrating mental health services into HIV care, but this specific approach is novel in the Kenyan context.
Who can join: the full rules
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 it's running
-
Kenya Medical Research Institute
Nairobi, Kenya Recruiting
Study contacts
- Principal investigator: Lisa Abuogi, MD, MSc — University of Colorado, Denver
- Study coordinator: Lisa Abuogi, MD,MSc
- Email: lisa.abuogi@cuanschutz.edu
- Phone: 303-724-9383
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.