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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02148094
Eligibility Criteria:
Inclusion Criteria:
* Self-identification as a current FSW
* Age 18 and older
* Self-reported interest in and willingness to take PrEP
* Score cutoff on risk screening tool / PrEP indication tool
* HIV-negative test at time of enrollment (per testing algorithm)
* No clinical signs of acute HIV infection
* Hepatitis-B virus antigen negative (upon screening)
* Creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) (upon screening)
* Not currently taking PrEP or enrolled in another PrEP demonstration project
* Negative urine pregnancy test at time of enrollment
* Lives within the catchment area of the project site and no plans to move away from the project area in the next 16 months
Exclusion Criteria:
* Under 18
* Does not meet inclusion criteria
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02148094
Study Brief:
Protocol Section:
NCT02148094