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New model aims to eliminate HIV transmission from mothers to infants in malawi

NCT ID NCT06493357

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 2,426 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Area 18 Health Centre

    RECRUITING

    Lilongwe, Malawi

  • Bwaila Hospital

    NOT_YET_RECRUITING

    Lilongwe, Central Region, Malawi

  • Monkey Bay Community Hospital

    RECRUITING

    Monkey Bay, Malawi

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