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

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.

• Proportion of mothers retained in care [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]
• Proportion of mothers with HIV viral suppression [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]
• Proportion of mothers who died [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]
• Proportion of mothers who transferred out [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]
• Proportion of infants receiving HIV diagnostic testing [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]
• Proportion of infants infected with HIV (vertical transmission) [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]
• Proportion of infants who died [Срок оценки: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.]