RecruitingNot ApplicableNCT06999928

Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV

Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy


Sponsor

Indiana University

Enrollment

200 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an enhanced peer support program — using trained "Mentor Mothers" who are themselves HIV-positive — to help pregnant and postpartum women with HIV stay on their treatment and prevent passing the virus to their babies. **You may be eligible if...** - You are a pregnant or recently postpartum woman living with HIV - You are 18 or older - You are already receiving HIV prevention and care services (PMTCT) at the study clinic - You can communicate in English or Kiswahili **You may NOT be eligible if...** - You are not pregnant or postpartum - You are under 18 - You are not enrolled in the clinic's HIV prevention program - You have a cognitive impairment that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEnhanced Mentor Mother Strategy

The enhanced Mentor Mother strategy introduces a structured approach to differentiated PMTCT support, led by trained peer counselors/Mentor Mothers (MM). Mentor Mothers will be trained on how to perform risk stratification, and they will use a standardized form to identify and document psychosocial and clinical risk factors. Based on these, MMs then deliver tailored interventions, including additional counseling, community outreach, and referrals. Fidelity assessments and a process of audit and feedback will be used to further refine the strategy, which builds on national differentiated service delivery guidelines and integrates into routine care without requiring added clinic staff.


Locations(1)

Burnt Forest Sub-District Hospital

Burnt Forest, Uasin Gishu County, Kenya

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NCT06999928


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