NCT06999928 Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV
| NCT ID | NCT06999928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2026-10-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-07-10 with a primary completion date of 2026-10-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Women who are not pregnant or postpartum * \<18 years of age * Not enrolled in PMTCT services at BFSDH * Unable to understand and provide informed consent in English or Kiswahili * Cognitive impairment that would interfere with ability to participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06999928 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06999928 currently recruiting?
Yes, NCT06999928 is actively recruiting participants. Contact the research team at jimcarlu@iu.edu for enrollment information.
Where is the NCT06999928 trial being conducted?
This trial is being conducted at Burnt Forest, Kenya.
Who is sponsoring the NCT06999928 clinical trial?
NCT06999928 is sponsored by Indiana University. The trial plans to enroll 200 participants.
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