Study of the PAC-Man Model to Improve HIV Testing and Care for Mothers and Infants in Malawi

What this Trial Is About

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.

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