Clinical trial NCT06117163: Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Kenya Medical Research Institute
name: University of Alabama at Birmingham
First posted: 2023-11-03
Enrollment: 900
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A type 2 hybrid effectiveness-implementation trial with a stepped-wedge design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Recovery of women from depression
timeFrame: Baseline, 6 months postpartum, 12 months postpartum
measure: Recovery of women from anxiety
timeFrame: Baseline, 6 months postpartum, 12 months postpartum
measure: Change in the proportion of women with combined retention and treatment success outcome
timeFrame: Baseline, 6 months postpartum, 12 months postpartum
Secondary outcomes:
measure: Infant weight at birth
timeFrame: Birth
measure: Proportion of women with preterm delivery of women who experienced adverse pregnancy outcomes
timeFrame: Birth
measure: Result of infant HIV test
timeFrame: Birth, 6 weeks, 6 months, 12 months
measure: Infant retention in care
timeFrame: Birth, 6 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: University of Colorado, Denver
name: Lisa Abuogi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: