NCT06999928Recruiting
Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV
Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Differentiated service delivery (DSD) is a care model that tailors services based on clients' needs, helping to improve both the quality and efficiency of care. This hybrid implementation-effectiveness study will test whether an enhanced MM strategy that uses DSD can be successfully carried out and improve health outcomes for mothers and infants. The study will take place at Burnt Forest Sub-District Hospital (BFSDH) in Kenya. Researchers will ask: * Can the enhanced MM strategy be delivered as planned and accepted by patients and staff? * Does the strategy improve clinical outcomes like keeping mothers in PMTCT care, achieving HIV viral suppression, completing infant HIV testing, and preventing HIV transmission to infants? Researchers will compare health outcomes before and after the strategy is introduced at BFSDH, and also compare outcomes at other similar clinics that continue with standard MM services. Women who choose to participate will meet with a MM during their routine antenatal and postnatal clinic visits. They will be offered the enhanced MM support, but can choose to receive standard care if they prefer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 22 May 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 12 Oct 2026
- Lead sponsor
- Indiana University
- Diseases
- HIV
- NCT number
- NCT06999928
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 10 Jul 2025 to the primary completion date, 12 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment that would interfere with ability to participate in the study
Age
- \<18 years of age
Other
- Women who are not pregnant or postpartum
- Not enrolled in PMTCT services at BFSDH
- Unable to understand and provide informed consent in English or Kiswahili
Who the study is looking for
- Pregnant and postpartum women living with HIV (and their infants born during the study)
- ≥18 years of age
- Enrolled in PMTCT services at BFSDH
- Able to understand and provide informed consent in English or Kiswahili
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Burnt Forest Sub-District Hospital Coordinator of this site? Confirm its status | Burnt Forest | Kenya | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.