New model aims to eliminate HIV transmission from mothers to infants in malawi
NCT ID NCT06493357
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study is testing a new approach called PAC-Man to help prevent HIV from passing from mothers to their babies. About 2,426 mothers and infants in Malawi will take part. The goal is to see if this model helps more babies get tested for HIV early and ensures mothers receive proper viral load monitoring, compared to the current standard of care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,426 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Area 18 Health Centre
RECRUITINGLilongwe, Malawi
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Bwaila Hospital
NOT_YET_RECRUITINGLilongwe, Central Region, Malawi
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Monkey Bay Community Hospital
RECRUITINGMonkey Bay, Malawi
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Other studies related to the condition(s) this trial covers.
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- Can local clinics keep more people with HIV in care?
- Can a phone call keep HIV-Positive mothers and babies on track?
- Can a phone app and a health worker ease depression in rural HIV care?