HIV-1-infectionUPLIFTNCT07293559
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
An observational study of HIV-1-infection and Breastfeeding, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Breastfeeding, Pregnancy Related
- How many people
- 1,150 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Feb 2026to 24 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
5030, Emory University School of Medicine Clinical Research Site
Atlanta, Georgia, 30322
Andres Camacho-Gonzalez, acamac2@emory.edu
LaTeshia Thomas-Seaton, lseaton@emory.edu
- Recruiting
University of Colorado, Denver (CRS 5052)
Aurora, Colorado, 80045
Christiana Smith-Anderson, MD, PhD, 303-724-4483, Christiana.smith@childrenscolorado.org
Carrie Chambers, RN, BSN, 720-777-4424, carrie.chambers@childrenscolorado.org
- Not yet recruiting
Johns Hopkins University (CRS 5092)
Baltimore, Maryland, 21287
Allison Agwu, MD, ScM, 410-614-3917, ageorg10@jhmi.edu
Amanda Haines, BSN, RN, 443-287-8888, Ahaines8@jhmi.edu
- Recruiting
Lurie Children's Hospital of Chicago (CRS 4001)
Chicago, Illinois, 60614
Jennifer Jao, 312-227-4080, JJao@luriechildrens.org
- Not yet recruiting
University of Florida (5051)
Jacksonville, Florida, 32209
Demi Venturella, RN, 904-244-3397, Demi.Venturella@jax.ufl.edu
Mobeen Rathore, MD
- Not yet recruiting
University of Southern California (CRS 5048)
Los Angeles, California, 90089
James Homans, MD, 213-509-9811, homans@usc.edu
Yvonne Morales, LVN, 323-865-1561, ytr@usc.edu
- Not yet recruiting
David Geffen School of Medicine at UCLA (CRS 5112)
Los Angeles, California, 90095
Jaime Deville, MD, 310-825-9660, jdeville@mednet.ucla.edu
- Not yet recruiting
St. Jude Childrens Research Hosp, Memphis (6501)
Memphis, Tennessee, 38105
Katherine Knapp, 901-448-4774, katherine.knapp@stjude.org
- Not yet recruiting
Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
Miami, Florida, 33136
Charles Mitchell, 305-243-2755, cmitchel@med.miami.edu
- Not yet recruiting
University California, San Diego (CRS 4601)
San Diego, California, 92103
Megan Loughran, 858-534-9218, meloughran@ucsd.edu
Stephen Spector, MD
- Not yet recruiting
Jacobi Med. Ctr. Bronx NICHD CRS (5013)
The Bronx, New York, 10461
Marlene Burey, 718-918-4783, Marlene.burey@nychhc.org
About this study
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.
Read the 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.
- Conditions
- HIV-1-infection, Breastfeeding, Pregnancy Related
- Being tested
- No intervention provided in this study
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention provided in this studyOther
None; No intervention provided in this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No intervention provided in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
CA 1: Factors influencing infant feeding decision
Qualitative themes from in-depth interviews
Measured: 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
Measured: Monthly, through study completion, up until 5 years
CA 2: Infant feeding method chosen
Binary outcome
Measured: At 48 weeks post birth
CA 2: Breastfeeding initiation among those who intended to breastfeed
Binary outcome
Measured: At 48 weeks post birth
CA 2: Duration of breastfeeding among PPWH who breastfeed
Numerical outcome
Measured: Through 96 weeks post birth
CA 2: Completion of intended duration of breastfeeding
Binary outcome
Measured: 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
Measured: At 48 weeks post birth
CA 2: Breast milk samples with detectable HIV DNA or RNA
Binary outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 3 years
Secondary outcomes (12)
CA 1: Approaches to support infant feeding decisions and improve quality of care
Qualitative themes from in-depth interviews
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, up to 5 years
CA 2: Cost per case of medical condition prevented by breastfeeding
Numerical outcome
Measured: 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
Measured: At 20 Weeks, At 48 Weeks
CA 2: Satisfaction with infant feeding decision and decision regret survey scores
Numerical outcome, by infant feeding method
Measured: At 20 weeks, At 48 weeks
CA 2: Infant HIV acquisition
Binary outcome, by infant feeding method
Measured: 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
Measured: At 20 weeks, At 48 weeks
CA 2: Score classification of each Ages and Stages developmental area
Ordinal outcome
Measured: At 20 weeks, At 48 weeks
CA 2: Plasma HIV viral load
Numerical outcome and categorical outcome
Measured: 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
Measured: Through 48 weeks post birth, At weaning up to 96 weeks post birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start24 Feb 2026
- Primary completion24 Apr 2031 (estimated)
- Study completion24 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- University of Colorado, Denver, Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Lisa Abuogi, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293559
- Sponsor's protocol ID
- IMPAACT 2046
- Acronym
- UPLIFT
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Publications
Smith C, Barr EA, Hampanda K, Trumbull M, Wu H, McKinney J, Buisson S, Hoffmann C, Brown C, Hutchinson AB, Amico KR, Asiodu IV, McFarland EJ, Lampe MA, Cholli PA, Varechtchouk O, Esber A, Kourtis AP, Abuogi L. Understanding practices of lactation and infant feeding together with women with HIV: the UPLIFT observational study protocol. Front Reprod Health. 2026 Jul 8;8:1856899. doi: 10.3389/frph.2026.1856899. eCollection 2026.
PubMed 42488399
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
- ClinicalTrials.gov ID
- NCT07293559
- Acronym / sponsor ID
- UPLIFT / IMPAACT 2046
- Conditions
- HIV-1-infection, Breastfeeding, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- University of Colorado, Denver, Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 24 Apr 2031 (estimated)
- Study completion
- 24 Apr 2031 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core Activity 1 | – | Other: No intervention provided in this studyThis 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 | – | Other: No intervention provided in this studyThis 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 | – | Other: No intervention provided in this studyThis core activity aims to pilot and assess the feasibility and acceptability of a national registry of breastfeeding women with HIV in the US. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention provided in this studyNone; No intervention provided in this study | Other | Core Activity 1, Core Activity 2, Core Activity 3 |
Primary outcome
CA 1: Factors influencing infant feeding decision
Time frame: Within 28 days and 2 years of Enrollment
Qualitative themes from in-depth interviews
CA 1: Infants born to women with HIV who receive any breast milk
Time frame: Monthly, through study completion, up until 5 years
Binomial outcome from site level surveys
CA 2: Infant feeding method chosen
Time frame: At 48 weeks post birth
Binary outcome
CA 2: Breastfeeding initiation among those who intended to breastfeed
Time frame: At 48 weeks post birth
Binary outcome
CA 2: Duration of breastfeeding among PPWH who breastfeed
Time frame: Through 96 weeks post birth
Numerical outcome
CA 2: Completion of intended duration of breastfeeding
Time frame: Through 96 weeks post birth
Binary outcome
CA 2: Mixed method analysis of infant feeding practices from in-depth interviews and survey data
Time frame: At 48 weeks post birth
Descriptive joint display table, with qualitative key themes and quantitative findings
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
Binary outcome
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
Numerical outcome
CA 3: Data completed in registry
Time frame: Through study completion, an average of 3 years
Binary outcome; whether specified percentage of data is completed in registry
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
Numerical outcome
CA 3: Completion of two visit entries for at least three eligible participants
Time frame: Through study completion, an average of 3 years
Binary outcome; whether sites complete entries
12 secondary outcomes
CA 1: Approaches to support infant feeding decisions and improve quality of care
Time frame: Within 28 days and 2 years of Enrollment
CA 1: Descriptive results of current practices, burden, benefits and resources
Time frame: Monthly, through study completion, up to 5 years
CA 2: Median cost per postpartum woman with HIV and infant pair
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
Time frame: Through study completion, up to 5 years
CA 2: Cost per case of medical condition prevented by breastfeeding
Time frame: Through study completion, up to 5 years
CA 2: Changes in scores of mental health and quality of life surveys
Time frame: At 20 Weeks, At 48 Weeks
CA 2: Satisfaction with infant feeding decision and decision regret survey scores
Time frame: At 20 weeks, At 48 weeks
CA 2: Infant HIV acquisition
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)
Time frame: At 20 weeks, At 48 weeks
CA 2: Score classification of each Ages and Stages developmental area
Time frame: At 20 weeks, At 48 weeks
CA 2: Plasma HIV viral load
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
Time frame: Through 48 weeks post birth, At weaning up to 96 weeks post birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42488399Smith C, Barr EA, Hampanda K, Trumbull M, Wu H, McKinney J, Buisson S, Hoffmann C, Brown C, Hutchinson AB, Amico KR, Asiodu IV, McFarland EJ, Lampe MA, Cholli PA, Varechtchouk O, Esber A, Kourtis AP, Abuogi L. Understanding practices of lactation and infant feeding together with women with HIV: the UPLIFT observational study protocol. Front Reprod Health. 2026 Jul 8;8:1856899. doi: 10.3389/frph.2026.1856899. eCollection 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Abuogi study chair
University of Colorado, Denver
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Breastfeeding, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Levy (202-884-8480, llevy@fhi360.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CA 1: Factors influencing infant feeding decision (time frame: Within 28 days and 2 years of Enrollment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07293559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.