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

NCT06999928 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

  • Hiv
  • Transmission Vertical
  • Viremia
  • Adherence, Treatment
  • Stigmatization
  • Socioeconomic Adversity
  • Health Care Utilization
  • Health Care Acceptability
  • Peer Group
  • Mothers

Interventions

BEHAVIORAL

Enhanced 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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Indiana University

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-10-12
Completion
2026-10-12

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06999928 on ClinicalTrials.gov