Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Kenya
Burnt Forest Sub-District Hospital
RECRUITING
Burnt Forest
Contact Information
Primary
James G Carlucci, MD, MPH
jimcarlu@iu.edu
+1 317 944 7260
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2026-10-12
Participants
Target number of participants: 200
Treatments
Experimental: Enhanced Mentor Mother Strategy
Participants will receive support from a Mentor Mother (MM) who delivers a risk-based, differentiated package of PMTCT services tailored to the needs of pregnant and postpartum women living with HIV (WLHIV). At each clinic visit, the MM will assess maternal and infant risk using a structured tool. Based on the result, the MM provides tailored support, such as counseling, navigation, linkage to resources, or increased follow-up. WLHIV without identified risks receive a streamlined support package. The strategy is integrated into routine antenatal and postnatal care at the study site.
Related Therapeutic Areas
Sponsors
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Indiana University

This content was sourced from clinicaltrials.gov