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

NCT06117163 | Recruiting DMC

• 1 other identifier: 23-0498
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; Mental Disorder

Keywords

HIV transmission; Prevention of Mother to Child Transmission; Linkage to care; Retention in care; Antiretroviral therapy adherence; Infant Health; Maternal CD4/viral loads; Early infant diagnosis; Acceptability of interventions; Vertical transmission; Mental Health; The Collaborative Care Model; Problem Solving Therapy; Stigma

Outcome Measures

Primary Outcomes (3)

• Recovery of women from depression

  Depression score is calculated and severity assessed through a survey utilizing the Patient Health Questionnaire Depression Scale (PHQ-9). PHQ-9 score is obtained by adding a score for each question (total points). A total score of 0-4 suggests none to minimal depression severity, a score of 5-9 mild depression severity, a score of 10-19 moderate depression severity, and a score of 20-27 severe depression. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from \>10 points to equal or less 10 points between baseline and 12 months postpartum.

  Baseline, 6 months postpartum, 12 months postpartum

• Recovery of women from anxiety

  Anxiety score is calculated and severity assessed through a survey utilizing the Generalized Anxiety Disorder 7-item (GAD-7). GAD-7 score is obtained by adding a score for each question (total points). A total score of 0-4 suggests none to minimal anxiety severity, a score of 5-9 mild anxiety severity, a score of 10-14 moderate anxiety severity, and a score of 15-21 severe anxiety. Recovery from the anxiety of pregnant and postpartum women living with HIV will be assessed as the change of a total GAD-7 score from \>10 points to equal or less 10 points between baseline and 12 months postpartum.

  Baseline, 6 months postpartum, 12 months postpartum

• Change in the proportion of women with combined retention and treatment success outcome

  The change in the proportion of women with the combined outcome of HIV care retention (didn't miss any HIV care appointment by 14 or more days) and a suppressed HIV RNA (\<400 copies/ml) among pregnant and postpartum women living with HIV assessed through medical records between baseline, 6 months postpartum, and 12 months postpartum.

  Baseline, 6 months postpartum, 12 months postpartum

Secondary Outcomes (4)

• Infant weight at birth

  Birth

• Proportion of women with preterm delivery of women who experienced adverse pregnancy outcomes

  Birth

• Result of infant HIV test

  Birth, 6 weeks, 6 months, 12 months

• Infant retention in care

  Birth, 6 weeks, 6 months, 12 months

Study Arms (1)

Collaborative Care Model (CCM)

EXPERIMENTAL

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.

Behavioral: Collaborative Care Model

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.

Also known as: Tunawiri model

Collaborative Care Model (CCM)

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• imminent plans of suicide
• severe impairment due to severe mental, neurological or substance use disorders.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Kenya Medical Research Institute: collaborator
• University of Alabama at Birmingham: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Mental Disorders; Psychological Well-Being; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior; Social Behavior

Study Officials

• Lisa Abuogi, MD, MSc

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Abuogi, MD,MSc

CONTACT

303-724-9383; lisa.abuogi@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A type 2 hybrid effectiveness-implementation trial with a stepped-wedge design

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

KE (1)