Enhanced Mentor Mother support for pregnant and postpartum women living with HIV
Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy
The team will test whether enhanced Mentor Mother support that tailors care to each woman's needs helps pregnant and postpartum women with HIV stay in care, suppress their viral load, and prevent passing HIV to their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Burnt Forest, Uasin Gishu County) |
| Trial ID | NCT06999928 on ClinicalTrials.gov |
What this trial studies
This hybrid implementation-effectiveness project will implement an enhanced Mentor Mother (MM) strategy at Burnt Forest Sub-District Hospital in Kenya that uses differentiated service delivery (DSD) and structured risk stratification at each clinical encounter. Mentor Mothers—peer supporters—will provide adherence counseling, psychosocial support, and targeted follow-up based on identified risk factors such as viremia, stigma, and non-disclosure. The study will measure implementation outcomes (feasibility, acceptability, fidelity) while also collecting preliminary clinical outcomes including retention in PMTCT care, maternal viral suppression, infant HIV testing completion, and vertical transmission. Data will come from routine clinic encounters, MM interactions, and program records to compare outcomes under the enhanced approach.
Who should consider this trial
Good fit: Ideal candidates are pregnant or postpartum women living with HIV who are 18 or older, enrolled in PMTCT services at Burnt Forest Sub-District Hospital, and able to consent in English or Kiswahili.
Not a fit: Women who are not receiving PMTCT care at Burnt Forest, are under 18, cannot consent in English or Kiswahili, or have cognitive impairment that prevents participation are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the enhanced MM strategy could help more mothers stay in PMTCT care, achieve viral suppression, and reduce mother-to-child HIV transmission.
How similar studies have performed: Mentor Mother peer-support programs have demonstrated benefit for PMTCT outcomes, but combining Mentor Mothers with structured, risk-based differentiated service delivery is a newer approach with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Women who are not pregnant or postpartum * \<18 years of age * Not enrolled in PMTCT services at BFSDH * Unable to understand and provide informed consent in English or Kiswahili * Cognitive impairment that would interfere with ability to participate in the study
Where this trial is running
Burnt Forest, Uasin Gishu County
- Burnt Forest Sub-District Hospital — Burnt Forest, Uasin Gishu County, Kenya (Recruiting)
Study contacts
- Study coordinator: James G Carlucci, MD, MPH
- Email: jimcarlu@iu.edu
- Phone: +1 317 944 7260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.