Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT07293559
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT07293559
Study Brief:
Protocol Section:
NCT07293559