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HIV and breastfeeding: new study seeks answers for moms
NCT ID NCT07293559
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
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About 1,150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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.
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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Genom att skicka in godkänner du våra Användarvillkor
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
11 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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5030, Emory University School of Medicine Clinical Research Site
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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David Geffen School of Medicine at UCLA (CRS 5112)
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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Jacobi Med. Ctr. Bronx NICHD CRS (5013)
NOT_YET_RECRUITINGThe Bronx, New York, 10461, United States
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Johns Hopkins University (CRS 5092)
NOT_YET_RECRUITINGBaltimore, Maryland, 21287, United States
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Lurie Children's Hospital of Chicago (CRS 4001)
RECRUITINGChicago, Illinois, 60614, United States
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St. Jude Childrens Research Hosp, Memphis (6501)
NOT_YET_RECRUITINGMemphis, Tennessee, 38105, United States
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Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
NOT_YET_RECRUITINGMiami, Florida, 33136, United States
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University California, San Diego (CRS 4601)
NOT_YET_RECRUITINGSan Diego, California, 92103, United States
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University of Colorado, Denver (CRS 5052)
RECRUITINGAurora, Colorado, 80045, United States
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University of Florida (5051)
NOT_YET_RECRUITINGJacksonville, Florida, 32209, United States
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University of Southern California (CRS 5048)
NOT_YET_RECRUITINGLos Angeles, California, 90089, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a cancer drug flush out hidden HIV?
- Can two antibodies and a cancer drug free people with HIV from daily pills?
- Can Mom's workout shape Baby's heart health?
- Can a TB infection leave a mark on the placenta?
- Do unsuppressed HIV infections fuel new cases in ethiopia?
- Can a wearable sensor read breast fullness and milk flow?