Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States

NCT07293559 | Recruiting DMC

• 1 other identifier: IMPAACT 2046
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 11

Brief Summary

IMPAACT 2046/UPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and their families in the United States. It will employ both qualitative and quantitative research methods to address existing knowledge gaps and to understand the clinical, behavioral, and social factors influencing infant feeding decisions. As part of the study's mixed method approach, a longitudinal cohort study of mothers and their infants will be established. The study also aims to pilot a national registry of breastfeeding women living with HIV in the United States.

Conditions

Breastfeeding; HIV-1-infection; Pregnancy Related

Outcome Measures

Primary Outcomes (12)

• CA 1: Factors influencing infant feeding decision

  Qualitative themes from in-depth interviews

  Within 28 days and 2 years of Enrollment

• CA 1: Infants born to women with HIV who receive any breast milk

  Binomial outcome from site level surveys

  Monthly, through study completion, up until 5 years

• CA 2: Infant feeding method chosen

  Binary outcome

  At 48 weeks post birth

• CA 2: Breastfeeding initiation among those who intended to breastfeed

  Binary outcome

  At 48 weeks post birth

• CA 2: Duration of breastfeeding among PPWH who breastfeed

  Numerical outcome

  Through 96 weeks post birth

• CA 2: Completion of intended duration of breastfeeding

  Binary outcome

  Through 96 weeks post birth

• CA 2: Mixed method analysis of infant feeding practices from in-depth interviews and survey data

  Descriptive joint display table, with qualitative key themes and quantitative findings

  At 48 weeks post birth

• CA 2: Breast milk samples with detectable HIV DNA or RNA

  Binary outcome

  Through 48 weeks post birth; At weaning up to 96 weeks post birth

• CA 2: Viral load measured in different breast milk compartments

  Numerical outcome

  Through 48 weeks post birth; At weaning up to 96 weeks post birth

• CA 3: Data completed in registry

  Binary outcome; whether specified percentage of data is completed in registry

  Through study completion, an average of 3 years

• CA 3: Median score on Feasibility of Intervention Measure, Acceptability of Intervention Measure and Appropriateness of Intervention Measures

  Numerical outcome

  Through study completion, an average of 3 years

• CA 3: Completion of two visit entries for at least three eligible participants

  Binary outcome; whether sites complete entries

  Through study completion, an average of 3 years

Secondary Outcomes (12)

• CA 1: Approaches to support infant feeding decisions and improve quality of care

  Within 28 days and 2 years of Enrollment

• CA 1: Descriptive results of current practices, burden, benefits and resources

  Monthly, through study completion, up to 5 years

• CA 2: Median cost per postpartum woman with HIV and infant pair

  Through study completion, up to 5 years

• CA 2: Cost effectiveness ratio presented as cost per quality adjusted life year saved in breastfeeding mother/infant pair

  Through study completion, up to 5 years

• CA 2: Cost per case of medical condition prevented by breastfeeding

  Through study completion, up to 5 years

Study Arms (3)

Core Activity 1

This core activity aims to explore current site-level infant feeding practices and infant feeding decision-making and preferences at selected sites in the US.

Other: No intervention provided in this study

Core Activity 2

This core activity aims to examine infant feeding practices and outcomes among women with HIV at selected sites in the US and to describe the financial implications of different infant feeding choices.

Other: No intervention provided in this study

Core Activity 3

This core activity aims to pilot and assess the feasibility and acceptability of a national registry of breastfeeding women with HIV in the US.

Other: No intervention provided in this study

Interventions

No intervention provided in this study OTHER

None; No intervention provided in this study

Core Activity 1; Core Activity 2; Core Activity 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: collaborator
• Centers for Disease Control and Prevention: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead

Study Sites (11)

University of Southern California (CRS 5048)

Los Angeles, California, 90089, United States

NOT YET RECRUITING

David Geffen School of Medicine at UCLA (CRS 5112)

Los Angeles, California, 90095, United States

NOT YET RECRUITING

University California, San Diego (CRS 4601)

San Diego, California, 92103, United States

NOT YET RECRUITING

University of Colorado, Denver (CRS 5052)

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida (5051)

Jacksonville, Florida, 32209, United States

NOT YET RECRUITING

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

Miami, Florida, 33136, United States

NOT YET RECRUITING

5030, Emory University School of Medicine Clinical Research Site

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Lurie Children's Hospital of Chicago (CRS 4001)

Chicago, Illinois, 60614, United States

RECRUITING

Johns Hopkins University (CRS 5092)

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Jacobi Med. Ctr. Bronx NICHD CRS (5013)

The Bronx, New York, 10461, United States

NOT YET RECRUITING

St. Jude Childrens Research Hosp, Memphis (6501)

Memphis, Tennessee, 38105, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Core Activity 2 participants will be asked whether they agree to storage and future research testing of breastmilk specimens. Human genetic testing of leftover specimens is optional and may be declined.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lisa Abuogi

  University of Colorado, Denver

  STUDY CHAIR

Central Study Contacts

Lisa Levy

CONTACT

202-884-8480; llevy@fhi360.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 19, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): April 24, 2031
• Study Completion (Estimated): April 24, 2031
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT)
• Access Criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network and CDC. * For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network and CDC. * By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Locations

US (11)