NCT06117163 Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
| NCT ID | NCT06117163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2024-10-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Lisa Abuogi, MD, MSc
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06117163 clinical trial?
This trial is open to female participants only, aged 15 Years or older, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06117163 currently recruiting?
Yes, NCT06117163 is actively recruiting participants. Contact the research team at lisa.abuogi@cuanschutz.edu for enrollment information.
Where is the NCT06117163 trial being conducted?
This trial is being conducted at Nairobi, Kenya.
Who is sponsoring the NCT06117163 clinical trial?
NCT06117163 is sponsored by University of Colorado, Denver. The principal investigator is Lisa Abuogi, MD, MSc at University of Colorado, Denver. The trial plans to enroll 900 participants.