New study aims to help pregnant moms with HIV thrive
NCT ID NCT06117163
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a program called Tunawiri (meaning 'thrive') that adds mental health screening, counseling, and support to regular HIV care for pregnant and postpartum women in Kenya. The goal is to improve depression, anxiety, and HIV treatment success. Nine hundred women will take part, and researchers will track their mental health and HIV outcomes for a year after giving birth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Collaborative care model (counseling, screening, and support)
- What this could lead to
- If successful, this could provide an effective way to integrate mental health support into routine HIV care, improving well-being and health outcomes for mothers and their babies.
- What could go wrong
- This is a behavioral intervention study, not a drug trial, so results may vary by setting. The study is still recruiting, and long-term effects are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 900 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kenya Medical Research Institute
RECRUITINGNairobi, Kenya
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