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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT04774666
Eligibility Criteria:
Inclusion Criteria for Index parent/caregivers:
* HIV-positive diagnosis
* 18 years old or older
* Emancipated minors (15-17 years of age) with eligible children
Inclusion Criteria for eligible children:
* Biological children (of an index parent/caregiver) 18 months - 14 years of age with an unknown HIV status
* Non-biological children living in the same household as the index parent/caregivers where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased)
* Biological children (of an index parent/caregiver) 18 months - 14 years of age, as well as non-biological children living in the same household as the index parent/caregiver where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with a known previous HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that there is reason to suspect a new exposure
Inclusion criteria for participation in survey after completion of care giver-assisted oral fluid-based HIV screening:
• Adult index parents who complete the oral-based HIV screening with at least one eligible child, regardless of screening result.
Exclusion Criteria for Index parent/caregivers:
* Adults answering "yes" to any of the first three intimate partner violence (IPV) risk assessment questions
* Adults answering "yes", "maybe" or I don't know" to the fourth IPV question
* Those unable to provide independent informed consent due to mental disability or other limitations (as deemed by study staff)
Exclusion Criteria for eligible children:
* Children \<18 months of age
* Children 18 months - 14 years of age with a known HIV-positive status
* Biological children (of an index parent/caregiver) 18 months - 14 years of age where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with previous known HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that they have no reason to suspect a new exposure
* Non-biological children living in the same household as the index parent/caregiver age where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with previous known HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that they have no reason to suspect a new exposure
* Children still breastfeeding
* Children with cessation of breastfeeding \< 3 months
Exclusion criteria for participation in survey after completion of oral-based HIV screening:
• Adult index parent/caregivers who do not complete the oral-based HIV screening with at least one eligible child
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04774666
Study Brief:
Protocol Section:
NCT04774666