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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 15 years and older
• Women only
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this 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)

Conditions

Human Immunodeficiency Virus, Mental Disorder

Being tested

Collaborative Care Model

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

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Collaborative Care ModelBehavioural

  Also called Tunawiri 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).

   Measured: 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).

   Measured: 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).

   Measured: 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.

   Measured: Between baseline and up to 12 months PP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Nov 2023
2. Study start1 Oct 2024
3. Primary completion31 Jul 2027 (estimated)
4. Study completion31 May 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
• More trials run by University of Colorado, DenverThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.