An observational study in HIV-1-infection, Breastfeeding and Pregnancy Related, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Recruiting at 11 sites in United States. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Observational
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.
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:
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 1,150 is above the median of 158 across 207 observational studies indexed under Breast Feeding.
Browse Breast Feeding studies →International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Core Activity 1 Inclusion Criteria: Pregnant and Postpartum Women with
Belongs to one of the following five categories:
Core Activity 1 Inclusion Criteria: Healthcare Providers and Ancillary Healthcare Professionals
Core Activity 1 Inclusion Criteria: Influential Individuals
Core Activity 2 Inclusion Criteria: Pregnant and Postpartum Women with HIV and their Infant
Core Activity 3 Inclusion Criteria: Breastfeeding Postpartum Women with HIV and their Infant
Core Activity 3 Inclusion Criteria: Pilot Registry Testers
Exclusion Criteria: Core Activities 1-3
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
CA 1: Factors influencing infant feeding decision
Qualitative themes from in-depth interviews
Time frame: 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
Time frame: Monthly, through study completion, up until 5 years
CA 2: Infant feeding method chosen
Binary outcome
Time frame: At 48 weeks post birth
CA 2: Breastfeeding initiation among those who intended to breastfeed
Binary outcome
Time frame: At 48 weeks post birth
CA 2: Duration of breastfeeding among PPWH who breastfeed
Numerical outcome
Time frame: Through 96 weeks post birth
CA 2: Completion of intended duration of breastfeeding
Binary outcome
Time frame: 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
Time frame: At 48 weeks post birth
CA 2: Breast milk samples with detectable HIV DNA or RNA
Binary outcome
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
Numerical outcome
Time frame: 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
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
Numerical outcome
Time frame: 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
Time frame: Through study completion, an average of 3 years
CA 1: Approaches to support infant feeding decisions and improve quality of care
Qualitative themes from in-depth interviews
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, up to 5 years
CA 2: Cost per case of medical condition prevented by breastfeeding
Numerical outcome
Time frame: 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
Time frame: At 20 Weeks, At 48 Weeks
CA 2: Satisfaction with infant feeding decision and decision regret survey scores
Numerical outcome, by infant feeding method
Time frame: At 20 weeks, At 48 weeks
CA 2: Infant HIV acquisition
Binary outcome, by infant feeding method
Time frame: 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
Time frame: At 20 weeks, At 48 weeks
CA 2: Score classification of each Ages and Stages developmental area
Ordinal outcome
Time frame: At 20 weeks, At 48 weeks
CA 2: Plasma HIV viral load
Numerical outcome and categorical outcome
Time frame: 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
Time frame: Through 48 weeks post birth, At weaning up to 96 weeks post birth
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: 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.
Started Feb 2026 (actual). Primary completion is estimated for Apr 2031, 62 months after the start.
Of 86 non-industry observational studies under Breast Feeding, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's planned 62 months is above that.
Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 19 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group