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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Enhanced Mentor Mother StrategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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.

Time frame
Acceptability of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
3

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.

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

Secondary outcomes

1

Proportion of mothers retained in care

Proportion of women living with HIV (WLHIV) enrolled in PMTCT services (those pregnant and ≤18 months postpartum) who were not lost to follow-up during the period of observation, excluding those who died or transferred out.

Time frame
Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
2

Proportion of mothers with HIV viral suppression

Proportion of WLHIV enrolled in PMTCT services who received antiretroviral therapy for at least 3 months, had at least one HIV viral load test, and never had a result \>200 copies/ml during the period of observation.

Time frame
Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
3

Proportion of mothers who died

Proportion of WLHIV enrolled in PMTCT services who died during the period of observation.

Time frame
Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
4

Proportion of mothers who transferred out

Proportion of WLHIV enrolled in PMTCT services who transferred to another clinic during the period of observation.

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

Other outcomes

Sponsors and contacts

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Indiana University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator