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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05393193
Eligibility Criteria:
Inclusion criteria for point-of-care infant HIV testing:
1. Mother 18 years of age or older
2. Mother willing and able to provide verbal consent for infant testing
3. Infant birth weight ≥1.5kg
4. Presence of any of the following risk factors:
\<12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time \>24 weeks gestation in pregnancy; CD4 cell count known to be \<350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)
Exclusion criteria for point-of-care infant HIV testing:
1\) Medical condition making it unlikely that the infant will survive to 24 months
Inclusion criteria for infant longitudinal treatment cohort:
1. Mother 18 years of age or older
2. Mother willing and able to provide written informed consent for study participation for herself and her infant
3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
4. Infant eligible for ART treatment in accordance with the Botswana government program
5. Infant birth weight ≥1.5 kg
Exclusion criteria for infant longitudinal treatment cohort:
1. Medical condition making it unlikely that the infant will survive to 24 months
2. Infant unable to start treatment-dose ART \< 168 hours of age
3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05393193
Study Brief:
Protocol Section:
NCT05393193