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

NCT06493357 | Recruiting

• 2 other identifiers: 24-05611P01HD112215
• Study Type: interventional
• Target: 2,426
• Locations: 1 country
• Sites: 3

Brief Summary

Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to:

1. 1.Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing.
2. 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. 3.Compare implementation outcomes between the PAC-Man model and SOC.

Conditions

HIV Prevention

Keywords

HIV Treatment

Outcome Measures

Primary Outcomes (1)

• Proportion of infants who receive EID testing by age 6 months

  Proportion of infants exposed to HIV who receive EID testing by age 6 months among the enumerated cohort of MIPs with infants at least 6 weeks old at all study sites.

  Within 12 months of MIP enrollment in the national EMTCT program

Secondary Outcomes (25)

• Proportion of infants who receive EID testing by age 2 months

  Within 12 months of MIP enrollment in the national EMTCT program

• Proportion of infants who receive EID testing by age 12 months

  Within 12 months of MIP enrollment in the national EMTCT program

• Proportion of high-risk infants who receive EID testing by age 6 months

  Within 12 months of MIP enrollment in the national EMTCT program

• Proportion of infants who initiate ART

  Within 12 months of MIP enrollment in the national EMTCT program

• Median infant results return time

  Within 12 months of MIP enrollment in the national EMTCT program

Study Arms (2)

PAC-Man Model

EXPERIMENTAL

PAC-Man represents an integrated DSD model for mothers and infants that brings the following three evidence-based practices into the community for EMTCT: 1) pediatric active case finding using novel POC EID technology; 2) same-day ART initiation for infants newly diagnosed with HIV infection; and 3) mVL testing and back-to-care services. PAC-Man uses a mobile approach to offer EMTCT services in the community and reach "high risk" MIPs. Delivering the PAC-Man model will be done under the auspices of routine care, applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings.

Behavioral: PAC-Man

Standard of care (control arm)

ACTIVE COMPARATOR

Routine care as provided by the Ministry of Health.

Behavioral: Standard of Care

Interventions

PAC-Man BEHAVIORAL

PAC-Man represents an integrated DSD model for mothers and infants that brings the following three evidence-based practices into the community for EMTCT: 1) pediatric active case finding using novel POC EID technology; 2) same-day ART initiation for infants newly diagnosed with HIV infection; and 3) mVL testing and back-to-care services. PAC-Man uses a mobile approach to offer EMTCT services in the community and reach "high risk" MIPs. Delivering the PAC-Man model will be done under the auspices of routine care, applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings.

PAC-Man Model

Standard of Care BEHAVIORAL

Routine care as provided by Ministry of Health.

Standard of care (control arm)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.

You may not qualify if:

• None.
• The criteria for Enumerated MIP Field Survey is as follows:
• Age 16 years or older.
• Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.
• 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:
• Age 16 years or older.
• Met high-risk criteria for PAC-Man model.
• Participated in a field survey.
• Decline informed consent.
• The criteria for Focus Group Discussions is as follows:
• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Bwaila Hospital

Lilongwe, Central Region, Malawi

NOT YET RECRUITING

Area 18 Health Centre

Lilongwe, Malawi

RECRUITING

Monkey Bay Community Hospital

Monkey Bay, Malawi

RECRUITING

Related Publications (1)

• Herce ME, Cassidy C, Munson A, Edwards JK, Rutstein SE, Matoga M, Kumwenda C, Simon KR, van Oosterhout JJ, Cox CM, Kamanga F, Kumwenda W, Phiri S, Rambiki E, Thawani A, Huwa J, Malewezi B, Mvalo T, Bula A, Chinula L, Hoffman I, Squibb MA, Nyirenda RK, Saidi F, Hosseinipour MC, Chagomerana MB. Study design and procedures for a hybrid effectiveness-implementation incomplete stepped-wedge cluster-randomized trial to evaluate a differentiated point-of-care HIV diagnosis and management model for the prevention of vertical transmission of HIV in Malawi: The PAC-Man trial protocol. Implement Sci Commun. 2025 Jul 28;6(1):78. doi: 10.1186/s43058-025-00762-5.

  PMID: 40721832 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Herce, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Herce, MD, MPH

CONTACT

9198435996; michael_herce@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 10, 2024
• Study Start: March 27, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

MA (3)