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:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT03133728
Eligibility Criteria:
Inclusion criteria include IYCs:
1. 0 days (at birth) - 17 months of age;
2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;
3. The IYC must be born to mothers who:
1. attended ≥1 ANC visits without HIV testing; or
2. delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or
3. were documented as HIV-infected but never initiated ART; or
4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or
5. have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or
6. IYC not tested 6 weeks after cessation of breastfeeding.
4. With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).
Exclusion criteria include IYCs:
1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
2. Already known to be HIV-infected / receiving ART.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
17 Months
Study:
NCT03133728
Study Brief:
Protocol Section:
NCT03133728