Recruiting

Observational Study

Sponsor:

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Code:

NCT07293559

Conditions

HIV-1-infection

Breastfeeding

Pregnancy Related

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

No intervention provided in this study

Study Details

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

HIV-1-infection

Breastfeeding

Pregnancy Related

Study ID

NCT07293559

Start date

Feb 24, 2026

Status verified date

Mar, 2026

Completion date

Apr 24, 2031

Anticipated

Primary completion date

Apr 24, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

1150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

No intervention provided in this study

None; No intervention provided in this study

Primary outcome measure

  • CA 1: Factors influencing infant feeding decision [ Time Frame: Within 28 days and 2 years of Enrollment ]
  • CA 1: Infants born to women with HIV who receive any breast milk [ Time Frame: Monthly, through study completion, up until 5 years ]
  • CA 2: Infant feeding method chosen [ Time Frame: At 48 weeks post birth ]
  • CA 2: Breastfeeding initiation among those who intended to breastfeed [ Time Frame: At 48 weeks post birth ]
  • CA 2: Duration of breastfeeding among PPWH who breastfeed [ Time Frame: Through 96 weeks post birth ]
  • CA 2: Completion of intended duration of breastfeeding [ Time Frame: Through 96 weeks post birth ]
  • CA 2: Mixed method analysis of infant feeding practices from in-depth interviews and survey data [ Time Frame: At 48 weeks post birth ]
  • CA 2: Breast milk samples with detectable HIV DNA or RNA [ Time Frame: Through 48 weeks post birth; At weaning up to 96 weeks post birth ]
  • CA 2: Viral load measured in different breast milk compartments [ Time Frame: Through 48 weeks post birth; At weaning up to 96 weeks post birth ]
  • CA 3: Data completed in registry [ Time Frame: 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 [ Time Frame: Through study completion, an average of 3 years ]
  • CA 3: Completion of two visit entries for at least three eligible participants [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts and Locations

Central contacts

Lisa Levy

202-884-8480llevy@fhi360.org

Locations

University of Colorado, Denver (CRS 5052)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Christiana Smith-Anderson, MD, PhD

303-724-4483Christiana.smith@childrenscolorado.org

Carrie Chambers, RN, BSN

720-777-4424carrie.chambers@childrenscolorado.org

Lurie Children's Hospital of Chicago (CRS 4001)

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Jennifer Jao

312-227-4080JJao@luriechildrens.org

More Information

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by International Maternal Pediatric Adolescent AIDS Clinical Trials Group on 2026-03-27.