Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06999928

Pilot Implementation-Effectiveness Study of an 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

N/A

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

This research aims to evaluate an enhanced Mentor Mother (MM) strategy that provides risk-based, differentiated prevention of mother-to-child transmission of HIV (PMTCT) services to pregnant and postpartum women living with HIV (WLHIV) and their infants. The study will take place at Burnt Forest Sub-District Hospital in Kenya and will assess whether the enhanced MM approach can be delivered as planned and accepted by patients and staff, while also examining its impact on key clinical outcomes such as retention in care, viral suppression, infant HIV testing, and prevention of HIV transmission to infants. Participants will receive support from trained Mentor Mothers who will use a structured tool to assess maternal and infant risk at each clinic visit. Based on identified risks like HIV viremia, stigma, non-disclosure, and socioeconomic barriers, MMs will provide tailored counseling, navigation, outreach, and referrals. Women without identified risks will receive a streamlined support package. This enhanced MM strategy is integrated into routine antenatal and postnatal care and builds on national differentiated service delivery guidelines. Women choosing to participate will meet with a Mentor Mother during their regular clinic visits over a 15-month implementation period. Researchers will monitor fidelity, feasibility, and acceptability of the enhanced MM strategy using checklists, audits, observations, satisfaction surveys, and focus groups. Clinical outcomes such as maternal retention, viral suppression, infant HIV testing uptake, and HIV transmission rates will be assessed before and after the intervention and compared to similar clinics using standard MM services.

CONDITIONS

Brief 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 or provide informed consent in English or Kiswahili
  • Cognitive impairment interfering with study participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 15 months

Participants receive support from a Mentor Mother who delivers a risk-based, differentiated package of prevention of mother-to-child transmission (PMTCT) services tailored to the needs of pregnant and postpartum women living with HIV. At each clinic visit, the Mentor Mother assesses maternal and infant risk using a structured tool and provides tailored support such as counseling, navigation, and linkage to resources based on individual risk.

Clinic visits aligned with routine antenatal and postnatal care schedule

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

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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