NCT06493357 Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
| NCT ID | NCT06493357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | HIV Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,426 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,426 participants in total. It began in 2025-03-27 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Michael Herce, MD, MPH
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06493357 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying HIV Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06493357 currently recruiting?
Yes, NCT06493357 is actively recruiting participants. Contact the research team at michael_herce@med.unc.edu for enrollment information.
Where is the NCT06493357 trial being conducted?
This trial is being conducted at Lilongwe, Malawi, Lilongwe, Malawi, Monkey Bay, Malawi.
Who is sponsoring the NCT06493357 clinical trial?
NCT06493357 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Michael Herce, MD, MPH at University of North Carolina, Chapel Hill. The trial plans to enroll 2,426 participants.
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