NCT07293559 · International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
(UPLIFT)
What this study is about
IMPAACT 2046/UPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational group of participants 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- San Diego, California
- Aurora, Colorado
- Jacksonville, Florida
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- The Bronx, New York
- Memphis, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations