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Clinical trial Recruiting at 2 sites Interventional Ages 16 and up

A new model to prevent mother-to-child HIV transmission in Malawi

Official title: 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

Run by University of North Carolina, Chapel Hill · NCT06493357 · Data updated 2026-11-12

This study is testing a new community-based approach called the PAC-Man model to see if it can better prevent the spread of HIV from mothers to their babies in Malawi compared to standard care.

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Quick facts

Study typeInterventional
Ages16 Years and up
SexAll
Enrollment2426 (estimated)
SponsorUniversity of North Carolina, Chapel Hill
Academic / other
Locations3 sites (Lilongwe, Central Region and 2 other locations)
StatusRecruiting
StartedMarch 27, 2025
Main results expectedMarch 31, 2028
Study endsMarch 31, 2028
Registry record updatedSeptember 18, 2026
Trial IDNCT06493357 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include pregnant and breastfeeding women living with HIV who are enrolled in the national elimination of mother-to-child transmission program.

Probably not a fit

Patients who are not enrolled in the national EMTCT program or those who have previously participated in the field survey may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the PAC-Man model, an integrated approach to eliminate mother-to-child transmission of HIV by providing community-based services. It compares the effectiveness of this model against standard care in ensuring timely early infant diagnosis testing and maternal viral load testing for pregnant and breastfeeding women living with HIV. The study involves a large sample of mother-infant pairs, health providers, and policymakers to assess both clinical outcomes and implementation strategies. The PAC-Man model utilizes mobile care teams equipped with advanced diagnostic technology to reach high-risk populations.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rates of HIV transmission from mothers to infants in Malawi.

How similar studies have gone: Other studies have shown success with community-based interventions for HIV prevention, suggesting that this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Area 18 Health Centre
    Lilongwe, Malawi     Recruiting
  • Monkey Bay Community Hospital
    Monkey Bay, Malawi     Recruiting
  • Bwaila Hospital
    Lilongwe, Central Region, Malawi     Not yet recruiting

Study contacts

  • Principal investigator: Michael Herce, MD, MPH — University of North Carolina, Chapel Hill
  • Study coordinator: Michael Herce, MD, MPH
  • Email: michael_herce@med.unc.edu
  • Phone: 9198435996

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.