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Hiv / Transmission Vertical / Enhanced Mentor Mother Strategy · Interventional Study
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned hybrid implementation-effectiveness trial of an enhanced Mentor Mother strategy with differentiated service delivery for pregnant and postpartum women with HIV in Kenya. The study is recruiting and has not yet reported results; primary outcomes focus on fidelity, acceptability, and feasibility of the intervention, with secondary clinical outcomes including viral suppression, PMTCT care retention, and prevention of mother-to-child transmission.
Interventional, Single Group, Open label, Health Services Research purpose. Hiv, Transmission Vertical, Viremia, Adherence, Treatment, Stigmatization, Socioeconomic Adversity, Health Care Utilization, Health Care Acceptability, Peer Gr…; Female; age from 18 Years; accepts healthy volunteers. Intervention: Enhanced Mentor Mother Strategy. Compared with: Standard Mentor Mother services (offered to participants who decline enhanced strategy and delivered at comparison clinic sites).. n = 200. 1 site: Kenya.
This is a planned hybrid implementation-effectiveness trial of an enhanced Mentor Mother strategy with differentiated service delivery for pregnant and postpartum women with HIV in Kenya. The study is recruiting and has not yet reported results; primary outcomes focus on fidelity, acceptability, and feasibility of the intervention, with secondary clinical outcomes including viral suppression, PMTCT care retention, and prevention of mother-to-child transmission.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results are not yet available. When complete, this study will provide evidence on whether an enhanced Mentor Mother strategy using differentiated service delivery can improve PMTCT outcomes and retention in care for women with HIV. Clinicians should await results before drawing conclusions on effectiveness.
This is a clinical trial registration for a planned hybrid implementation-effectiveness study with no results yet reported; it describes study design and objectives only.
As stated by the source record.
Quoted from the source exactly as published.
Results are not yet available. When complete, this study will provide evidence on whether an enhanced Mentor Mother strategy using differentiated service delivery can improve PMTCT outcomes and retention in care for women with HIV. Clinicians should await results before drawing conclusions on effectiveness.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06999928). This is a study registration, not published results. Lead sponsor: Indiana University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Hiv, Transmission Vertical, Viremia, Adherence, Treatment, Stigmatization, Socioeconomic Adversity, Health Care Utilization, Health Care Acceptability, Peer Group, Mothers. Interventions: BEHAVIORAL: Enhanced Mentor Mother Strategy. Primary outcome measures: Fidelity: Proportion of enhanced Mentor Mother strategy tasks completed and services correctly assigned/delivered, as assessed by checklists, audits, and observations. , 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 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 of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.