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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT04846569
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older
2. HIV positive status (based on clinic records)
3. Confirmed pregnant (based on clinic records) and estimated to be 23-34 weeks gestation (clinic records or self-report)
4. Currently prescribed ART
5. Planning on remaining a resident of Cape Town for at least 6 months postpartum
6. Ability to speak isiXhosa or English
7. Able to provide informed consent
Exclusion Criteria:
* Failure to meet any of the inclusion criteria
* Significant pre-existing psychiatric comorbidity at enrolment that may impact ability to consent according to the judgement of study personnel (including cognitive impairment or known psychotic disorder) Note: mothers will not be withdrawn from the study following foetal complications or death
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04846569
Study Brief:
Protocol Section:
NCT04846569