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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT03431168
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV-infection (documented in medical record)
* Age ≥16 years
* Confirmed pregnancy, \<28 weeks estimated gestational age (by best obstetric estimate which may include ultrasound or fundal height and LMP)
* Live singleton pregnancy
* Receiving prenatal care at Mboppi Hospital or Mutengene Hospital
* Plan to receive follow up prenatal care and deliver at study facility
* Capable of providing written informed consent
* Able and agree to come to facility for febrile episodes or acute illness during pregnancy (with reimbursement of transportation costs).
* Agree to avoid antimalarial medications outside of study protocol.
Exclusion Criteria:
* Severe anemia (last hemoglobin \<6)
* History of severe adverse reaction to co-trimoxazole or azithromycin
* Active medical problem requiring inpatient evaluation at the time of screening
* Intention of moving far away from the facility during pregnancy or not likely to return for follow up care or delivery
* Signs or symptoms of early or active labor
* History of severe cardiac disease (including congestive heart failure, severe valvular disease or arrhythmias).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
55 Years
Study:
NCT03431168
Study Brief:
Protocol Section:
NCT03431168