Lactation and infant feeding practices among U.S. women living with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado, Denver (CRS 5052)
  Aurora, Colorado, United States Recruiting
• Lurie Children's Hospital of Chicago (CRS 4001)
  Chicago, Illinois, United States Recruiting
• 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 Florida (5051)
  Jacksonville, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Lisa Levy
• Email: llevy@fhi360.org
• Phone: 202-884-8480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.