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:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT02216734
Eligibility Criteria:
Inclusion Criteria:
* Pregnant mothers
* with documented HIV-1 infection attending an antenatal clinic for the current pregnancy
* Aged 18 years of age or greater
* Attending the clinic with no known intention at the time of enrolment to permanently migrate outside the catchment area of the clinic for the duration of the study follow-up period
* Estimated gestational age of 34 weeks or less at time of enrolment
* Willing to have her infant, when born, participate in the study.
* Able and willing to give informed consent to participate
Exclusion Criteria:
* Pregnant mothers with no documented HIV infection
* Under 18 years of age
* Not able or willing to give informed consent to participate
* Estimated gestational age of over 34 weeks when considered for possible enrolment
* Not residing in catchment area of clinic
* Planning to relocate out of the catchment area of the clinic for the duration of study follow-up period or longer
* Any condition that in the opinion of the investigators would interfere with adherence to study requirements. Such conditions include mental illness or active drug or alcohol use or dependence.
* Unwilling for her infant, when born, to participate in the infant component of the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02216734
Study Brief:
Protocol Section:
NCT02216734