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HIV and breastfeeding: new study seeks answers for moms

NCT ID NCT07293559

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how women with HIV in the United States decide to feed their babies, whether by breastfeeding or formula. Researchers will interview mothers and track their choices and health outcomes. The goal is to fill gaps in knowledge and create a national registry to better support these families.

What this could mean

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

What this could lead to
If successful, this study could provide crucial insights to help women with HIV make informed infant feeding decisions and improve clinical care guidelines.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any intervention, so it cannot prove what works best for everyone.

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.

Participants

About 1,150 people

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

Started

Feb 2026

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant and postpartum women with HIV (PPWH); healthcare providers (HCP) and ancillary healthcare professionals (AHP) who care for PPWH and/or their infants; other influential individuals who contribute to infant feeding decisions. Pilot registry testers who will enter data into the pilot registry.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Core Activity 1 Inclusion Criteria: Pregnant and Postpartum Women with HIV * Is of legal age or circumstance to provide independent informed consent * Belongs to one of the following five categories: * Is pregnant with a gestational age of 28 0/7 to 37 6/7 weeks at entry and is considering breastfeeding * Is pregnant with a gestational age of 28 0/7 to 37 6/7 weeks at entry and is not considering breastfeeding * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, did not breastfeed for any duration and has no intent to breastfeed * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, breastfed for less than four weeks, and has weaned * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, and breastfed for four weeks or longer * Diagnosed with HIV prior to or during the pregnancy * If preferred language is other than English, is willing to participate in interviews with an available translator. Core Activity 1 Inclusion Criteria: Healthcare Providers and Ancillary Healthcare Professionals * Is of legal age or circumstance to provide independent informed consent * Is a healthcare provider who self-identifies as an obstetrician, midwife, nurse, adult or pediatric infectious disease specialist, or advance practice provider who participated in the care of at least five PPWH and/or their infants over the three years prior to entry OR * Is an ancillary healthcare professional who self-identifies as a social worker, lactation support provider, patient navigator, pharmacist, doula who participated in the care of at least five PPWH and/or their infants over the three years prior to entry Core Activity 1 Inclusion Criteria: Influential Individuals * Has been identified by a PPWH enrolled in Core Activity 1 as aware of her HIV status and contributing to her infant feeding decisions * Is of legal age or circumstance to provide independent informed consent * If preferred language is other than English, is willing to participate in interviews with an available translator. Core Activity 2 Inclusion Criteria: Pregnant and Postpartum Women with HIV and their Infant * Is of legal age or circumstance to provide independent informed consent * Is pregnant with singleton fetus with a gestational age of ≥ 28 0/7 weeks at entry OR * Gave birth to a live born, singleton infant up to 7 days prior to entry * Diagnosed with HIV prior to or during the pregnancy * Expected to be available for the duration of follow-up Core Activity 3 Inclusion Criteria: Breastfeeding Postpartum Women with HIV and their Infant * Is of legal age or circumstance to provide independent informed consent * Must be up to 7 days postpartum with live-born infant * Diagnosed with HIV prior to or during the pregnancy * Breastfed her infant for any duration Core Activity 3 Inclusion Criteria: Pilot Registry Testers * Is of legal age or circumstance to provide independent informed consent * Working at a healthcare facility that provides care for women with HIV who are breastfeeding and/or their infants Exclusion Criteria: Core Activities 1-3 * Has any condition identified during the screening period that, in the opinion of site investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

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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

    11 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

  • 5030, Emory University School of Medicine Clinical Research Site

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • David Geffen School of Medicine at UCLA (CRS 5112)

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Jacobi Med. Ctr. Bronx NICHD CRS (5013)

    NOT_YET_RECRUITING

    The Bronx, New York, 10461, United States

  • Johns Hopkins University (CRS 5092)

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lurie Children's Hospital of Chicago (CRS 4001)

    RECRUITING

    Chicago, Illinois, 60614, United States

  • St. Jude Childrens Research Hosp, Memphis (6501)

    NOT_YET_RECRUITING

    Memphis, Tennessee, 38105, United States

  • Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • University California, San Diego (CRS 4601)

    NOT_YET_RECRUITING

    San Diego, California, 92103, United States

  • University of Colorado, Denver (CRS 5052)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida (5051)

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Southern California (CRS 5048)

    NOT_YET_RECRUITING

    Los Angeles, California, 90089, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.