Condition: HIV Prevention · Sponsor: University of North Carolina, Chapel Hill
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 effici…
This description comes directly from the study's public registry record.
Michael Herce, MD, MPH · 9198435996 · michael_herce@med.unc.edu
Always discuss trial participation with your own doctor first.
| Bwaila Hospital | Lilongwe, Central Region, Malawi | Not Yet Recruiting |
| Area 18 Health Centre | Lilongwe, Malawi | Recruiting |
| Monkey Bay Community Hospital | Monkey Bay, Malawi | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06493357