Clinical trial NCT06999928: Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV
Official title: Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Transmission Vertical
Viremia
Adherence, Treatment
Stigmatization
Socioeconomic Adversity
Health Care Utilization
Health Care Acceptability
Peer Group
Mothers
Keywords: prevention of mother-to-child transmission
retention
implementation
mentor mothers
differentiated service delivery
maternal-child health
Kenya
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-05-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pregnant and postpartum WLHIV will be screened for risk factors, then those with risk factors will received problem-focused MM support, while those without risk factors will receive less intensive MM support.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This is a hybrid implementation-effectiveness study of an enhanced Mentor Mother (MM) strategy for delivering 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 be conducted at Burnt Forest Sub-District Hospital (BFSDH), an Academic Model Providing Access to Healthcare (AMPATH)-supported public health facility in Uasin Gishu County, Kenya.

Mentor Mothers (MMs) are peer advocates who support WLHIV in PMTCT programs, providing adherence counseling, psychosocial support, and retention assistance. Although MMs are a widely implemented, evidence-based intervention, current models generally do not differentiate services based on clients' individual risk profiles. The enhanced MM strategy evaluated in this study builds on the World Health Organization and Kenya Ministry of Health's recommendation for differentiated service delivery (DSD)-a patient-centered model that tailors services to individual needs.

This study will evaluate implementation outcomes (feasibility, acceptability, fidelity) while also gathering preliminary clinical effectiveness data of the enhanced MM strategy. The strategy includes structured, iterative risk stratification by MMs and PMTCT clinicians at each clinical encounter to identify clients at higher risk for poor PMTCT outcomes. Identified risk factors include HIV viremia, stigma and non-disclosure, and socioeconomic barriers. Based on the identified risk(s), MMs will deliver individualized, problem-focused support. WLHIV with no identifiable risk factors will receive a less-intensive service schedule aligned with national differentiated care guidelines.

Specific Aims:

* Aim 1: Use a mixed-methods approach to evaluate fidelity, feasibility, and acceptability of the enhanced MM strategy over a 15-month period. Data will include quantitative fidelity checklists, MM activity logs, chart audits, observation logs, and stakeholder focus group discussions.
* Aim 2: Assess preliminary effectiveness of the enhanced MM strategy on key maternal and infant outcomes using aggregate, routinely collected clinical data from AMPATH's medical record system. Outcomes include maternal retention in care, maternal HIV viral suppression, infant uptake of HIV diagnostic testing, and HIV vertical transmission. A within-site pre-post analysis will compare outcomes at BFSDH during the 12 months before and after implementation (excluding the first 3 months of roll out). A contemporaneous across-site analysis will compare outcomes at BFSDH (enhanced MM strategy) and three comparable clinics providing standard MM services during the same 12-month period.

The study is supported by the NIH through a K23 award (K23HD109056), and builds on extensive formative research, including qualitative interviews and human-centered design workshops with WLHIV, MMs, PMTCT clinicians, and policymakers. Pilot implementation is being guided by local stakeholders and is expected to inform the design of a future pragmatic trial. The enhanced MM strategy, if successful, may provide a scalable model for improving PMTCT outcomes in resource-constrained settings.

Eligibility 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

Primary outcomes:
measure: Fidelity: Proportion of enhanced Mentor Mother strategy tasks completed and services correctly assigned/delivered, as assessed by checklists, audits, and observations.
timeFrame: Fidelity to the enhanced MM strategy will be assessed throughout the 15-month implementation period, and a process of audit and feedback will be used to enhance fidelity and further refine the strategy.
measure: Acceptability: Participant ratings of acceptability of the enhanced Mentor Mother strategy, assessed by AIM scores, satisfaction surveys, and focus group discussions.
timeFrame: Acceptability of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
measure: Feasibility: Participant ratings of feasibility of the enhanced Mentor Mother strategy, assessed by FIM scores and focus group discussions.
timeFrame: Feasibility of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
Secondary outcomes:
measure: Proportion of mothers retained in care
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
measure: Proportion of mothers with HIV viral suppression
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
measure: Proportion of mothers who died
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
measure: Proportion of mothers who transferred out
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
measure: Proportion of infants receiving HIV diagnostic testing
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
measure: Proportion of infants infected with HIV (vertical transmission)
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
measure: Proportion of infants who died
timeFrame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Other outcomes:
Locations:
city: Burnt Forest
country: Kenya
facility: Burnt Forest Sub-District Hospital
state: Uasin Gishu
Study officials:
References: