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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorUniversity of Colorado, Denver

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

imminent plans of suicide

severe impairment due to severe mental, neurological or substance use disorders.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Collaborative Care Model (CCM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of women who recovered from probable depression at 12 months postpartum

The depression score is calculated and severity assessed through a brief screener, the Patient Health Questionnaire Depression Scale (PHQ-9). PHQ-9 score is obtained by adding the 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 (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N).

Time frame
Baseline, 12 months postpartum
2

Proportion of women who recovered from probable anxiety at 12 months postpartum

The anxiety score is calculated and severity assessed through a brief screener, 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 at baseline (anxiety detected and coded as Y) less than 10 points at 12 months postpartum (anxiety not detected and coded as N).

Time frame
Baseline, 12 months postpartum
3

Proportion of women who recovered from probable depression and/or anxiety at 12 months postpartum

Composite variable of recovery from common mental health conditions: Out of women with depression and/or anxiety at baseline, Y=recovery if depression and anxiety are both coded as N at the follow-up point; N = if at least one of the variables (depression, anxiety) is coded as Y at the follow-up point. 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 (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N). Recovery from anxiety in pregnant and postpartum women living with HIV will be assessed as the change in total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) to less than 10 points at 12 months postpartum (anxiety not detected and coded as N).

Time frame
Baseline, 12 months postpartum
4

Proportion of women with combined HIV care retention and treatment success outcome up to 12 months postpartum

Composite variable based on medical records: Y=if all described variables coded as Y, N=if at least one of the following variable coded as N: (1) Y=if a woman was retained in HIV care (didn't miss any HIV care appointment by 14 or more days after baseline up to 12 months postpartum), N=if a woman missed at least one HIV care appointment after baseline up to 12 months postpartum; (2) Y=woman had sustained suppressed HIV RNA (\<400 copies/ml) after baseline up to 12 months postpartum, N=woman had at least one unsuppressed HIV RNA (≥400 copies/ml) during the period after baseline up to 12 months postpartum. Variables assessed through monthly abstraction of medical records among pregnant and postpartum women living with HIV between baseline and up to 12 months postpartum.

Time frame
Between baseline and up to 12 months PP

Secondary outcomes

1

Proportion of infants with low birth weight out of live births

A birth weight, measured in grams, and based on monthly abstraction of medical records, and categorized into normal weight (≥ 2500 grams at birth, coded as N) and low birth weight (\<2500 grams at birth, coded as Y).

Time frame
Birth
2

Proportion of women with preterm delivery out of live births

The proportion of women who experienced a preterm delivery based on medical records. Coded as Y if woman delivered \<37 weeks of pregnancy and coded as N if delivered ≥37 weeks of pregnancy.

Time frame
Birth
3

Infant HIV free survival

Proportion of infants alive and HIV-free at 12 months after birth. This is assessed in a brief interview and confirmed through medical records. Coded as Y if infant is alive and HIV-free at 12 months after birth, and coded as N if infant is not alive or HIV free at 12 months after birth.

Time frame
Birth, 12 months
4

Infant retention in HIV care for infants who tested HIV+ among women completing 12 months postpartum

The proportion of infants who tested HIV-positive who remained enrolled in HIV care at 12 months, assessed in a brief interview and confirmed through medical records. Coded as Y if HIV+ infant is retained in care at 12 months after birth, and coded as N if infant is not retained in HIV care at 12 months after birth.

Time frame
Birth, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

University of North Carolina, Chapel Hill

Collaborator

Kenya Medical Research Institute

Collaborator

University of Alabama at Birmingham

Collaborator