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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT06250504
Eligibility Criteria:
Inclusion Criteria:
All young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH/HIV service
Documented HIV negative test
Suitable for PrEP and/or already on PrEP
Weight \> 35 kg
Understand the required dosing schedule and HIV testing.
Aware that details can be shared with a peer navigator to support their follow-up
If pregnant or breast feeding and/or planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast feeding for CAB LA has not been established and oral daily PrEP is a safe alternative.
Exclusion Criteria:
History or presence of allergy to the study drugs or their components
Investigator assessment find them not suitable
Additional exclusion criteria for specific products:
CAB LA: Taking medication that is contraindicated (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Rifampin, rifapentine) and Severe mental health disorder, Hep B surface antigen positive, living with hepatitis C and not yet treated, or abnormal liver function tests (ALT more than two times the upper limit of normal)
DapiRing: Pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
30 Years
Study:
NCT06250504
Study Brief:
Protocol Section:
NCT06250504