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

Sponsor: University of North Carolina, Chapel Hill • ClinicalTrials.gov ID: NCT06493357

Registry updated: 2026-09-18

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Description

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.

Interventions

PAC-Man (Behavioral)
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.
Standard of Care (Behavioral)
Routine care as provided by Ministry of Health.

Eligibility criteria

The criteria for Enumerated MIP Cohort is as follows: Inclusion Criteria: * Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey. Exclusion Criteria: * None. The criteria for Enumerated MIP Field Survey is as follows: Inclusion Criteria: * Age 16 years or older. * Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey. Exclusion Criteria: * Documented transferred out from a site prior to the field survey. * Participated previously in the field survey. * Decline informed consent. The criteria for In-Depth Interviews is as follows: Inclusion criteria: * Age 16 years or older. * Met high-risk criteria for PAC-Man model. * Participated in a field survey. Exclusion criteria: * Decline informed consent. The criteria for Focus Group Discussions is as follows: Inclusion criteria: * Age 18 years or older. * MOH or implementing partner professional or lay health worker at a study site (such as nurses, community health workers, health surveillance assistants, and HIV diagnostic assistants) * Generally familiar with the PAC-Man model and/or EMTCT/ EID service delivery at their site. Exclusion criteria: * Decline informed consent. The criteria for Key Informant Interviews is as follows: Inclusion criteria: * Age 18 years or older. * HIV/ EMTCT policy maker OR MOH/ PEPFAR implementing partner senior manager. * Generally familiar with HIV and/or EMTCT/ EID service delivery. Exclusion criteria: * Decline informed consent. The criteria for Implementation Actor Questionnaires is as follows: Inclusion criteria: * Age 18 years or older. * Professional or lay health provider at a study site. * Generally familiar with HIV and/or EMTCT/ EID service delivery at their site. * Participated in a focus group discussion. Exclusion criteria: * Decline informed consent.

Conditions

HIV Prevention

Locations

Bwaila Hospital — Lilongwe, Central Region, Malawi
Area 18 Health Centre — Lilongwe, Malawi
Monkey Bay Community Hospital — Monkey Bay, Malawi

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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