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

NCT ID: NCT06117163

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-05-31

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.

Detailed Description

Common mental disorders (CMD) of depression and anxiety are prevalent and largely untreated among Kenyan pregnant and postpartum women living with HIV (PPWH). CMD lead to poor maternal and child health outcomes and contribute to lack of HIV care engagement and virologic failure in PPWH. While efficacious treatments for CMD exist, scaling treatment within routine health care in low- and middle-income (LMIC) settings will require stakeholder engagement and both effectiveness and implementation data to inform scale up and sustainability. The study team has integrated other efficacious interventions into antenatal (ANC) and HIV care in Kenya. The investigators now propose to integrate proven mental health services using a collaborative care model, combined with a low intensity evidence-based intervention (problem solving therapy), while targeting known social determinants of HIV-related health for PPWH (stigma and IPV). Building on the current multidisciplinary approach for HIV care in Kenya, the proposed Collaborative Care Model (CCM) will utilize existing peer mentor mothers, non-specialist behavioral care managers, and psychiatric nurses; and will incorporate a consultant psychiatrist into the ANC/HIV care team. Guided by the EPIS (Exploration-Preparation-Implementation-Sustainment) framework, the overall study goal is to integrate collaborative care for perinatal CMD within routine ANC/HIV services in Kenya, assess the costs and cost-effectiveness of this approach, and work with policy and decision makers to determine key considerations for scale-up. Specifically, in Aim 1, the investigators will identify contextual barriers and facilitators to refine an optimal integration model for delivering collaborative care model using multimethod data collection (focus groups with providers, in-depth interviews with key informants, and a clinic readiness checklist). A workshop with the study Advisory Board comprising of both county and national level stakeholders, will allow investigators to translate findings into a locally relevant CCM. In Aim 2, the investigators will test CCM in antenatal care for PPWH in a hybrid type 2 implementation-effectiveness trial using a stepped wedge design at 15 primary health care facilities in southwestern Kenya. The investigators will introduce CCM care for PPWH diagnosed with CMD during antenatal care. The co-primary health outcomes at 12 months postpartum will be (1) recovery from depression or anxiety symptoms in PPWH, and (2) proportion PPWH with sustained viral suppression and retention in HIV care. Key implementation outcomes are feasibility and acceptability. Finally, in Aim 3, the investigators will refine CCM implementation strategies through cost-effectiveness and dissemination research. The investigators will carry out costing and cost-effectiveness analysis and invite policy and decision-makers to participate in a nominal group technique process to elucidate factors for further scale up and sustainment of the CCM approach. Findings from this study will guide the development of a scalable model adaptable to other LMIC settings, contributing to global HIV and maternal health goals while addressing the burden of untreated CMD.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Collaborative Care Model (CCM)

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.

Group Type: EXPERIMENTAL

Collaborative Care Model

Intervention Type: 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.

Interventions

Collaborative 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Tunawiri model

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Abuogi, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Kenya Medical Research Institute

Nairobi, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Lisa Abuogi, MD,MSc

Role: CONTACT

Phone: 303-724-9383

Email: lisa.abuogi@cuanschutz.edu

Facility Contacts

Maricianah Onono, MBChB

Role: primary

Lisa Abuogi, MD

Role: backup

Other Identifiers

23-0498

Identifier Type: -

Identifier Source: org_study_id