Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,150
- 试验地点
- 11
- 主要终点
- CA 2: Breastfeeding initiation among those who intended to breastfeed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: No intervention provided in this study (Other)
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.
干预措施: No intervention provided in this study (Other)
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.
干预措施: No intervention provided in this study (Other)
结局指标
主要结局
CA 2: Breastfeeding initiation among those who intended to breastfeed
时间窗: At 48 weeks post birth
Binary outcome
CA 2: Duration of breastfeeding among PPWH who breastfeed
时间窗: Through 96 weeks post birth
Numerical outcome
CA 2: Completion of intended duration of breastfeeding
时间窗: Through 96 weeks post birth
Binary outcome
CA 1: Infants born to women with HIV who receive any breast milk
时间窗: Monthly, through study completion, up until 5 years
Binomial outcome from site level surveys
CA 2: Infant feeding method chosen
时间窗: At 48 weeks post birth
Binary outcome
CA 1: Factors influencing infant feeding decision
时间窗: Within 28 days and 2 years of Enrollment
Qualitative themes from in-depth interviews
CA 2: Mixed method analysis of infant feeding practices from in-depth interviews and survey data
时间窗: 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
时间窗: 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
时间窗: Through 48 weeks post birth; At weaning up to 96 weeks post birth
Numerical outcome
CA 3: Data completed in registry
时间窗: 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
时间窗: Through study completion, an average of 3 years
Numerical outcome
CA 3: Completion of two visit entries for at least three eligible participants
时间窗: Through study completion, an average of 3 years
Binary outcome; whether sites complete entries
次要结局
- CA 1: Approaches to support infant feeding decisions and improve quality of care(Within 28 days and 2 years of Enrollment)
- CA 1: Descriptive results of current practices, burden, benefits and resources(Monthly, through study completion, up to 5 years)
- CA 2: Median cost per postpartum woman with HIV and infant pair(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(Through study completion, up to 5 years)
- CA 2: Cost per case of medical condition prevented by breastfeeding(Through study completion, up to 5 years)
- CA 2: Changes in scores of mental health and quality of life surveys(At 20 Weeks, At 48 Weeks)
- CA 2: Satisfaction with infant feeding decision and decision regret survey scores(At 20 weeks, At 48 weeks)
- CA 2: Infant HIV acquisition(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)(At 20 weeks, At 48 weeks)
- CA 2: Score classification of each Ages and Stages developmental area(At 20 weeks, At 48 weeks)
- CA 2: Plasma HIV viral load(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(Through 48 weeks post birth, At weaning up to 96 weeks post birth)