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: * 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 Type
OBSERVATIONAL
Enrollment
1,150
None; No intervention provided in this study
University of Southern California (CRS 5048)
Los Angeles, California, United States
NOT_YET_RECRUITINGDavid Geffen School of Medicine at UCLA (CRS 5112)
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity California, San Diego (CRS 4601)
San Diego, California, United States
NOT_YET_RECRUITINGUniversity of Colorado, Denver (CRS 5052)
Aurora, Colorado, United States
RECRUITINGUniversity of Florida (5051)
Jacksonville, Florida, United States
NOT_YET_RECRUITINGUniv of Miami Pediatric/Perinatal HIV/AIDS (5127)
Miami, Florida, United States
NOT_YET_RECRUITING5030, Emory University School of Medicine Clinical Research Site
Atlanta, Georgia, United States
NOT_YET_RECRUITINGLurie Children's Hospital of Chicago (CRS 4001)
Chicago, Illinois, United States
RECRUITINGJohns Hopkins University (CRS 5092)
Baltimore, Maryland, United States
NOT_YET_RECRUITINGJacobi Med. Ctr. Bronx NICHD CRS (5013)
The Bronx, New York, United States
NOT_YET_RECRUITING...and 1 more locations
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)
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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