Testing a clinic and community model to prevent mother-to-child HIV transmission in Malawi
Tests a new care model for infant and mother HIV testing in Malawi.
Plain-language title generated from the registry record
Registry title: Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
Key facts
- Where
- Lilongwe and Monkey Bay, MalawiSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for mothers and their infants in the national program to prevent HIV passing from mother to child, at 12 study health facilities in Malawi. It also includes health workers and policy makers.
- Age
- Mothers and in-depth interview participants: 16 years or older. Health workers, policy makers and managers: 18 years or older.
- Sex
- All sexes
- Disease stage
- Mothers and infants in the national program to prevent mother-to-child transmission of HIV; for in-depth interviews, mothers who meet the high-risk criteria for the PAC-Man model.
- Earlier treatment
- Must have been enrolled in the national program to prevent mother-to-child transmission of HIV at a study site in the 12 months before the survey.
Main reasons for not taking part
- Transferred out of a study site before the field survey
- Already took part in the field survey
- Declines informed consent
Read by machine on 9 November 2026.
Where in Malawi
- Area 18 Health CentreLilongwe, MalawiTaking people
- Bwaila HospitalLilongwe, MalawiNot yet recruiting
- Monkey Bay Community HospitalMonkey Bay, MalawiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of North Carolina, Chapel Hill
- Trial code
- NCT06493357
- Record updated
- 18 September 2026
- Original description
Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to:Read full original descriptionShow less
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
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.
Inclusion: Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey; Age 16 years or older; Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey; Age 16 years or older; Met high-risk criteria for PAC-Man model; Participated in a field survey; 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; 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; 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: Documented transferred out from a site prior to the field survey; Participated previously in the field survey; None; The criteria for Enumerated MIP Field Survey is as follows:; Decline informed consent; The criteria for In-Depth Interviews is as follows:; Decline informed consent; The criteria for Focus Group Discussions is as follows:; Decline informed consent; The criteria for Key Informant Interviews is as follows:; Decline informed consent; The criteria for Implementation Actor Questionnaires is as follows:; Decline informed consent.
The criteria for Enumerated MIP Cohort is as follows:.