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

NCT06999928 | Recruiting DMC

• 2 other identifiers: 24102K23HD109056
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Fidelity: Proportion of enhanced Mentor Mother strategy tasks completed and services correctly assigned/delivered, as assessed by checklists, audits, and observations.

  Fidelity is defined as the degree to which an intervention is implemented as intended. In this study, fidelity to the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (checklists, audits) and qualitative (observations, logs) methods. A checklist of essential tasks will quantify adherence to MM workflows, calculated as the proportion of tasks completed out of those intended. Audits of clinical records, screening tools, and MM logs will assess accuracy of risk-based service delivery, calculated as the proportion of correctly assigned and delivered services. Direct observations will assess the quality of MM service delivery, and content logs will capture which MM components are delivered and how participants respond.

  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.

• Acceptability: Participant ratings of acceptability of the enhanced Mentor Mother strategy, assessed by AIM scores, satisfaction surveys, and focus group discussions.

  Acceptability is the perception among implementation stakeholders that an intervention is agreeable or satisfactory. In this study, acceptability of the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (questionnaires) and qualitative (focus group discussions) methods. The Acceptability of Intervention Measure (AIM) is a brief, validated questionnaire that will be administered to participants. A satisfaction survey will also be administered to identify parts of the strategy that cause frustration or other negative emotions and parts of the strategy that cause positive emotions. Results from AIM and satisfaction surveys will then be used to guide focus group discussions that will qualitatively assess perspectives about the acceptability of the enhanced MM strategy. Focus group discussions will be audio recorded, translated, and transcribed for thematic analysis.

  Acceptability of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.

• Feasibility: Participant ratings of feasibility of the enhanced Mentor Mother strategy, assessed by FIM scores and focus group discussions.

  Feasibility is the extent to which an intervention can be successfully carried out within a given context. In this study, feasibility of the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (questionnaires) and qualitative (focus group discussions) methods. The Feasibility of Intervention Measure (FIM) is a brief, validated questionnaire that will be administered to participants. Results from the FIM will then be used to guide focus group discussions that will qualitatively assess perspectives about the feasibility and readiness for scale-up of the enhanced MM strategy. Focus group discussions will be audio recorded, translated, and transcribed for thematic analysis.

  Feasibility of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.

Secondary Outcomes (7)

• Proportion of mothers retained in care

  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

  Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.

• Proportion of mothers who died

  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

  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

  Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.

Study Arms (1)

Enhanced Mentor Mother Strategy

EXPERIMENTAL

Participants will receive support from a Mentor Mother (MM) who delivers a risk-based, differentiated package of PMTCT services tailored to the needs of pregnant and postpartum women living with HIV (WLHIV). At each clinic visit, the MM will assess maternal and infant risk using a structured tool. Based on the result, the MM provides tailored support, such as counseling, navigation, linkage to resources, or increased follow-up. WLHIV without identified risks receive a streamlined support package. The strategy is integrated into routine antenatal and postnatal care at the study site.

Behavioral: Enhanced Mentor Mother Strategy

Interventions

Enhanced Mentor Mother Strategy BEHAVIORAL

The enhanced Mentor Mother strategy introduces a structured approach to differentiated PMTCT support, led by trained peer counselors/Mentor Mothers (MM). Mentor Mothers will be trained on how to perform risk stratification, and they will use a standardized form to identify and document psychosocial and clinical risk factors. Based on these, MMs then deliver tailored interventions, including additional counseling, community outreach, and referrals. Fidelity assessments and a process of audit and feedback will be used to further refine the strategy, which builds on national differentiated service delivery guidelines and integrates into routine care without requiring added clinic staff.

Enhanced Mentor Mother Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Burnt Forest Sub-District Hospital

Burnt Forest, Uasin Gishu County, 30100, Kenya

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Viremia; Treatment Adherence and Compliance; Stereotyping; Financial Stress; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Social Behavior; Stress, Psychological; Behavioral Symptoms

Central Study Contacts

James G Carlucci, MD, MPH

CONTACT

+1 317 944 7260; jimcarlu@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)