Health TrialsbyHealthPanel

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

ConditionsHuman Immunodeficiency VirusMental Disorder
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

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.

Time frame
Baseline, 6 months postpartum, 12 months postpartum
2

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.

Time frame
Baseline, 6 months postpartum, 12 months postpartum
3

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.

Time frame
Baseline, 6 months postpartum, 12 months postpartum

Secondary outcomes

1

Infant weight at birth

A birth weight, measured in grams, and based on medical records, and categorized into normal weight (equal or more than 2500 grams at birth), low birth weight (\<2500 grams at birth), very low birth weight (\<1,500 grams at birth), and extremely low birth weight (\<1,000 grams at birth).

Time frame
Birth
2

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

The proportion of women who experienced a preterm delivery, measured as delivery \<37 weeks of pregnancy) based on medical records.

Time frame
Birth
3

Result of infant HIV test

Result of infant HIV test at birth, 6 weeks, 6 months, and 12 months, assessed through medical records and categorized into HIV positive or HIV negative.

Time frame
Birth, 6 weeks, 6 months, 12 months
4

Infant retention in care

Continuous visit adherence from birth through 12 months after birth (no missed clinic/pharmacy visit \>14 days) assessed through medical records.

Time frame
Birth, 6 weeks, 6 months, 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

Source ClinicalTrials.gov
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