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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; HIV-1-infection; Breastfeeding
• Intervention / Treatment: Other: No intervention provided in this study

Detailed Description

This is a convergent mixed-method, multisite study to identify factors in infant feeding decisions and explore infant feeding perspectives, preferences, practices and outcomes among women with HIV in the US. Feasibility and acceptability of developing a national registry of breastfeeding women with HIV in the US will also be assessed. The study sites will enroll women with HIV who are pregnant or postpartum (PPWH), healthcare providers (HCPs) and ancillary healthcare professionals (AHPs), other influential individuals who contribute to infant feeding decisions, and pilot registry testers.

The study will be comprised of three core activities:

• Core Activity 1: Will explore the multifaceted process of infant feeding decision-making, and describe clinical practice, and counseling approaches via in-depth interviews (IDIs) and surveys. IDIs will be completed with PPWH, influential people who contribute to infant feeding decisions, HCPs, and AHPs. HCPs and AHPs will also complete self-administered surveys, and site staff at each site will complete site-level surveys to inform a landscape analysis.
• Core Activity 2: Will establish an observational prospective cohort of PPWH, and their liveborn infants, to examine current infant feeding practices and outcomes and their associated costs and cost benefits.
• Core Activity 3: Will develop and pilot a national registry of breastfeeding women with HIV and assess its feasibility and acceptability among pilot registry testers.

• Study Type: Observational
• Enrollment (Estimated): 1150

Contacts and Locations

• Study Contact: Name: Lisa Levy; Phone Number: 202-884-8480; Email: llevy@fhi360.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • Not yet recruiting
      • University of Southern California (CRS 5048)
      • Contact: Yvonne Morales, LVN; Phone Number: 323-865-1561; Email: ytr@usc.edu
      • Contact: James Homans, MD; Phone Number: 213-509-9811; Email: homans@usc.edu
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • David Geffen School of Medicine at UCLA (CRS 5112)
      • Contact: Jaime Deville, MD; Phone Number: 310-825-9660; Email: jdeville@mednet.ucla.edu
    • San Diego, California, United States, 92103
      • Not yet recruiting
      • University California, San Diego (CRS 4601)
      • Contact: Megan Loughran; Phone Number: 858-534-9218; Email: meloughran@ucsd.edu
      • Principal Investigator: Stephen Spector, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado, Denver (CRS 5052)
      • Contact: Christiana Smith-Anderson, MD, PhD; Phone Number: 303-724-4483; Email: Christiana.smith@childrenscolorado.org
      • Contact: Carrie Chambers, RN, BSN; Phone Number: 720-777-4424; Email: carrie.chambers@childrenscolorado.org
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Not yet recruiting
      • University of Florida (5051)
      • Principal Investigator: Mobeen Rathore, MD
      • Contact: Demi Venturella, RN; Phone Number: 904-244-3397; Email: Demi.Venturella@jax.ufl.edu
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
      • Contact: Charles Mitchell; Phone Number: 305-243-2755; Email: cmitchel@med.miami.edu
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • 5030, Emory University School of Medicine Clinical Research Site
      • Contact: Andres Camacho-Gonzalez; Email: acamac2@emory.edu
      • Contact: LaTeshia Thomas-Seaton; Email: lseaton@emory.edu
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Recruiting
      • Lurie Children's Hospital of Chicago (CRS 4001)
      • Contact: Jennifer Jao; Phone Number: 312-227-4080; Email: JJao@luriechildrens.org
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins University (CRS 5092)
      • Contact: Allison Agwu, MD, ScM; Phone Number: 410-614-3917; Email: ageorg10@jhmi.edu
      • Contact: Amanda Haines, BSN, RN; Phone Number: 443-287-8888; Email: ahaines8@jhmi.edu
  • New York
    • The Bronx, New York, United States, 10461
      • Not yet recruiting
      • Jacobi Med. Ctr. Bronx NICHD CRS (5013)
      • Contact: Marlene Burey; Phone Number: 718-918-4783; Email: Marlene.burey@nychhc.org
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Not yet recruiting
      • St. Jude Childrens Research Hosp, Memphis (6501)
      • Contact: Katherine Knapp; Phone Number: 901-448-4774; Email: katherine.knapp@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; None; 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; None; 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; None; No intervention provided in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CA 1: Approaches to support infant feeding decisions and improve quality of care	Qualitative themes from in-depth interviews	Within 28 days and 2 years of Enrollment
CA 1: Descriptive results of current practices, burden, benefits and resources	Site surveys, provider surveys, In-depth Interviews	Monthly, through study completion, up to 5 years
CA 2: Median cost per postpartum woman with HIV and infant pair	Numerical outcome, by feeding approach	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	Numerical outcome	Through study completion, up to 5 years
CA 2: Cost per case of medical condition prevented by breastfeeding	Numerical outcome	Through study completion, up to 5 years
CA 2: Changes in scores of mental health and quality of life surveys	Numerical outcome, by infant feeding method	At 20 Weeks, At 48 Weeks
CA 2: Satisfaction with infant feeding decision and decision regret survey scores	Numerical outcome, by infant feeding method	At 20 weeks, At 48 weeks
CA 2: Infant HIV acquisition	Binary outcome, by infant feeding method	Through study completion, up to 96 weeks post birth
CA 2: Infant weight-for-age, length-for-age, head circumference-for-age (by z-score for sex)	Numerical outcome	At 20 weeks, At 48 weeks
CA 2: Score classification of each Ages and Stages developmental area	Ordinal outcome	At 20 weeks, At 48 weeks
CA 2: Plasma HIV viral load	Numerical outcome and categorical outcome	Through 48 weeks post birth, At weaning up to 96 weeks post birth
CA 2: Number of copies of HIV DNA or RNA per mL of milk	Numerical outcome	Through 48 weeks post birth, At weaning up to 96 weeks post birth

Collaborators and Investigators

• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: University of Colorado, Denver; National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Centers for Disease Control and Prevention
• Investigators: Study Chair: Lisa Abuogi, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): April 24, 2031
• Study Completion (Estimated): April 24, 2031

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: IMPAACT 2046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie results in the publication, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT)
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No