RecruitingNot ApplicableNCT06493357

Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi

UNCPM 22401 - Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model for the Elimination of Mother-to-Child Transmission of HIV in Lilongwe and Mangochi, Malawi

Sponsor

University of North Carolina, Chapel Hill

Enrollment

2,426 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Prevention

Summary

Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to: 1. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing. 2. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of pregnant and breastfeeding women living with HIV who receive guideline-adherent viral load testing. 3. Compare implementation outcomes between the PAC-Man model and SOC. Participants: The total study sample size is 2,426, including 2,304 mother-infant pair (MIP) survey participants, 48 high-risk pregnant/breastfeeding women living with HIV for in-depth interviews (from high-risk MIPs who participated in a survey); 10 PMTCT policy makers and Ministry of Health (MOH)/ President's Emergency Plan for AIDS Relief (PEPFAR) implementing partner senior managers for key informant interviews; and about 48-64 professional and lay health providers for focus group discussions and implementation actor surveys. To rigorously evaluate the PAC-Man model, investigators will use a hybrid (type 3) effectiveness-implementation incomplete stepped-wedge trial design. The hybrid incomplete stepped-wedge design is a rigorous quasi-experimental design that allows for incremental "rollout" of the PAC-Man model and serial measurement of both health outcomes (for infants and mothers in Objectives 1 and 2, respectively), as well as implementation outcomes (Objective 3). The incomplete stepped-wedge design is more efficient than a complete design, minimizes costs, and reduces participant burden, without sacrificing statistical precision. Using this design, sequential crossover from control (i.e., the SOC) to intervention (i.e., SOC plus the PAC-Man model) takes place at each 'step' using cluster randomization until all clusters (defined as a group of "sites," or health facilities plus the surrounding communities in its catchment area) receive the intervention. The 12 sites included in our study will be divided into 4 clusters of 3 sites each.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This trial evaluates a community-based, point-of-care approach to eliminate mother-to-child transmission of HIV in Malawi by finding and managing high-risk cases more effectively. You may be eligible if... - You are enrolled in Malawi's national HIV prevention program (EMTCT) at a study site within the past 12 months - For field surveys and interviews: you are 16 years or older - For focus group discussions: you are 18 or older and are a health worker or lay worker involved in HIV care at a study site - For key informant interviews: you are 18 or older and are an HIV/EMTCT policy maker or senior program manager You may NOT be eligible if... - You have transferred out of the study site before the survey - You have already participated in the field survey previously - You decline to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPAC-Man

PAC-Man represents an integrated DSD model for mothers and infants that brings the following three evidence-based practices into the community for EMTCT: 1) pediatric active case finding using novel POC EID technology; 2) same-day ART initiation for infants newly diagnosed with HIV infection; and 3) mVL testing and back-to-care services. PAC-Man uses a mobile approach to offer EMTCT services in the community and reach "high risk" MIPs. Delivering the PAC-Man model will be done under the auspices of routine care, applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings.

BEHAVIORALStandard of Care

Routine care as provided by Ministry of Health.