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

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

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2426 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (Academic / other)
• Locations: 3 sites (Lilongwe, Central Region and 2 other locations)
• Trial ID: NCT06493357 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

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.

Where this trial is running

Lilongwe, Central Region and 2 other locations

• Bwaila Hospital — Lilongwe, Central Region, Malawi (Not_yet_recruiting)
• Area 18 Health Centre — Lilongwe, Malawi (Recruiting)
• Monkey Bay Community Hospital — Monkey Bay, Malawi (Recruiting)

Study contacts

• Principal investigator: Michael Herce, MD, MPH — University of North Carolina, Chapel Hill
• Study coordinator: Michael Herce, MD, MPH

Conditions HIV Prevention; HIV Treatment