Lactation and infant feeding practices among U.S. women living with HIV
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
See how pregnant and postpartum women with HIV in the United States make infant feeding choices and what outcomes their infants experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1150 (estimated) |
| Sex | All |
| Sponsor | International Maternal Pediatric Adolescent AIDS Clinical Trials Group Research network |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT07293559 on ClinicalTrials.gov |
What this trial studies
This multisite, convergent mixed-methods project combines in-depth interviews, surveys, and a prospective observational cohort to document infant feeding preferences, practices, and outcomes among women with HIV. Qualitative interviews will be conducted with pregnant and postpartum women with HIV, their influencers, and healthcare providers, while providers and sites complete surveys to map counseling practices. A longitudinal cohort of mother–infant pairs will track feeding behaviors and clinical and cost outcomes over time. The study will also pilot a national registry of breastfeeding women with HIV to test feasibility and acceptability.
Who should consider this trial
Good fit: Pregnant or postpartum women with documented HIV who meet the study timing criteria (pregnant at 28 0/7–37 6/7 weeks or postpartum with a liveborn infant born after February 28, 2023, in the specified postpartum feeding categories) and who can provide informed consent are ideal candidates.
Not a fit: People who do not live in the study catchment areas, who fall outside the specified pregnancy/postpartum windows, or who seek an interventional treatment are unlikely to benefit directly from this observational project.
Why it matters
Potential benefit: If successful, the work could improve counseling, clinical guidance, and support resources for mothers with HIV who are making infant feeding decisions.
How similar studies have performed: Similar mixed-methods and cohort approaches have produced useful data internationally, but a multisite U.S. cohort and a pilot national registry for breastfeeding women with HIV remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 10 other locations
- University of Southern California (CRS 5048) — Los Angeles, California, United States (Not_yet_recruiting)
- David Geffen School of Medicine at UCLA (CRS 5112) — Los Angeles, California, United States (Not_yet_recruiting)
- University California, San Diego (CRS 4601) — San Diego, California, United States (Not_yet_recruiting)
- University of Colorado, Denver (CRS 5052) — Aurora, Colorado, United States (Recruiting)
- University of Florida (5051) — Jacksonville, Florida, United States (Not_yet_recruiting)
- Univ of Miami Pediatric/Perinatal HIV/AIDS (5127) — Miami, Florida, United States (Not_yet_recruiting)
- 5030, Emory University School of Medicine Clinical Research Site — Atlanta, Georgia, United States (Not_yet_recruiting)
- Lurie Children's Hospital of Chicago (CRS 4001) — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University (CRS 5092) — Baltimore, Maryland, United States (Not_yet_recruiting)
- Jacobi Med. Ctr. Bronx NICHD CRS (5013) — The Bronx, New York, United States (Not_yet_recruiting)
- St. Jude Childrens Research Hosp, Memphis (6501) — Memphis, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Lisa Levy
- Email: llevy@fhi360.org
- Phone: 202-884-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.