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New program aims to protect ugandan mothers and babies from HIV during pregnancy

NCT ID NCT06746675

Prevention Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a counseling program called Healthy Families PrEP for HIV-negative women in rural Uganda who are planning pregnancy or recently gave birth. The program provides information and support to help women take daily PrEP pills to prevent HIV. Researchers will enroll 660 women and measure how many start and continue PrEP, especially during pregnancy and after birth, to reduce HIV transmission to mothers and children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Healthy Families PrEP counselling intervention (behavioral intervention to promote PrEP use)
What this could lead to
If successful, this could provide a practical, community-based way to reduce HIV infections among women and their babies during pregnancy and breastfeeding.
What could go wrong
This is a behavioral intervention, not a drug; its success depends on women's willingness and ability to take PrEP consistently. The trial is not yet recruiting and results may not apply to other settings.

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 660 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2032

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

18 to 45 years

Sex

Female participants only

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.

Inclusion Criteria: * Age ≥18 years and ≤45 years * Willing and able to participate in the informed consent process * HIV-uninfected by self-report, but have indications for HIV prevention strategies, such as having a partner living with HIV or who they think may be living with HIV * Reporting pregnancy in the past 2 years, and/or desire to have a child in the next year, and/or have a partner who desires to a child in the next year * Fluent in English or local language * Living within 60km of a healthcare center included in the trial * HIV Negative (onsite rapid testing) Exclusion Criteria: * Not reporting pregnancy in the past 2 years * Does not report personal or partner desire to have a child in the next year * Not willing to provide informed consent * Not able to communicate in English or local language * Does not report pregnancy in the past 2 years and/or does not report personal or partner desire to have a child in the next year * Not able to communicate in English or local language * Living beyond 60km of the trial healthcare center * HIV-positive (onsite rapid testing)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Pre-exposure prophylaxis of HIV infection Pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Mbarara University of Science and Technology

    Mbarara, Uganda

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