Actively Recruiting
Led by University of North Carolina, Chapel Hill · Updated on 2025-09-26
2426
Participants Needed
3
Research Sites
N/A
Total Duration
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
Researchers are evaluating the PAC-Man model, an integrated differentiated services delivery (DSD) approach aimed at eliminating mother-to-child transmission of HIV in Malawi. This model combines three evidence-based practices: pediatric active case finding using point-of-care early infant diagnosis technology, same-day antiretroviral therapy initiation for infants newly diagnosed with HIV, and maternal viral load testing with back-to-care services. The study uses a hybrid effectiveness-implementation stepped-wedge design involving 12 sites divided into clusters to compare the PAC-Man model with standard care. The PAC-Man model is delivered through mobile care teams equipped with new diagnostic technology that brings services directly to the community, focusing on high-risk mother-infant pairs. The implementation strategy includes task shifting of testing and treatment duties to community health workers and changing service locations to more convenient community sites. Participants are randomly assigned by clusters to either receive the PAC-Man model alongside routine care or continue with standard Ministry of Health care. Participants include mothers and infants enrolled in the national EMTCT program, healthcare workers, policymakers, and implementing partners, totaling over 2,400 individuals. The study measures outcomes such as the proportion of infants receiving early infant diagnosis testing by 6 months, maternal viral load testing adherence, infant ART initiation, viral suppression, and retention in care. Data is collected over 12 months following enrollment, and implementation outcomes like adoption rates and cost per pediatric case are also assessed.
CONDITIONS
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive the PAC-Man model or standard care, which includes pediatric active case finding using point-of-care early infant diagnosis technology, same-day antiretroviral therapy initiation for infants diagnosed with HIV, and maternal viral load testing with back-to-care services. Services are delivered through mobile care teams in community settings under routine care.
Visits occur in the community as part of routine care; visit frequency may vary
Duration - Up to 12 months
Participants are monitored for infant HIV testing outcomes, ART initiation, viral suppression, and retention in care over 12 months following enrollment in the EMTCT program.
Assessments integrated with routine care visits up to 12 months post-enrollment
Total: 3 locations
1
Bwaila Hospital
Lilongwe, Central Region, Malawi
Not Yet Recruiting
2
Area 18 Health Centre
Lilongwe, Malawi
Actively Recruiting
3
Monkey Bay Community Hospital
Monkey Bay, Malawi
Actively Recruiting
M
Michael Herce, MD, MPH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Michael E Herce, Caitlin Cassidy, Alexandra Munson...
https://pubmed.ncbi.nlm.nih.gov/40721832