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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT04991402
Eligibility Criteria:
Inclusion Criteria:
For All Women:
* Confirmed pregnancy based on urine pregnancy test with viable gestation ≤ 18 weeks and 6 days by ultrasound
* Age 16 years or older
* No stated intention to relocate permanently outside of Cape Town through 2 years postpartum
For Women Living with HIV (WLHIV):
• Confirmed HIV infection based on medical record review and/or HIV antibody testing during antenatal care
For WLHIV continuing DTG in pregnancy (cDTG):
• Confirmed use of tenofovir 300mg + lamivudine 300mg/emtricitabine 200mg + dolutegravir 50mg (TLD) on the day of assessment
For WLHIV initiating DTG in pregnancy (iDTG):
• Planned initiation of TLD on the day of assessment or within 1 week thereafter, including women switching from efavirenz-based regimen
For women without HIV (HIV-):
• Confirmed HIV status by HIV antibody testing during antenatal care
Exclusion Criteria:
* In the opinion of the investigator, unable to provide informed consent due to mental or physical condition
* In the opinion of the investigator, unable to undertake BodPod assessment due to mental (eg, active psychosis or severe claustrophobia) or physical condition (eg, weight \>250 kg).
* Currently being treated for any form of diabetes mellitus or hypertensive disorder based on participant self-report and medical record review
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT04991402
Study Brief:
Protocol Section:
NCT04991402