Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06999928

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

Led by Indiana University · Updated on 2025-07-15

200

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant and postpartum women living with HIV (and their infants born during the study)
  • 18 years of age or older
  • Enrolled in PMTCT services at Burnt Forest Sub-District Hospital
  • Able to understand and provide informed consent in English or Kiswahili
Not Eligible

You will not qualify if you...

  • Women who are not pregnant or postpartum
  • Under 18 years of age
  • Not enrolled in PMTCT services at Burnt Forest Sub-District Hospital
  • Unable to understand and provide informed consent in English or Kiswahili
  • Cognitive impairment that would interfere with ability to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Burnt Forest Sub-District Hospital

Burnt Forest, Uasin Gishu County, Kenya, 30100

Actively Recruiting

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Research Team

J

James G Carlucci, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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