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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02755350
Eligibility Criteria:
Inclusion Criteria:
* Self-reported interest in and willingness to take PrEP
* Score cut-off on PrEP screening tool
* HIV- negative test at time of enrollment (per testing algorithm)
* No clinical symptoms of acute HIV infection including fever, lymphadenopathy, pharyngitis, skin rash, myalgias/arthralgias.
* Hepatitis-B virus antigen negative (upon screening)
* Creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) (upon screening)
* Not breastfeeding
* Not currently taking PrEP or enrolled in another PrEP demonstration project
* Willingness to visit the project site of choice for follow up visits throughout the project period
* Knowledge of spoken English or Kiswahili
* Is in good general health and does not report a medical condition which may make their participation unsafe.
* Is not currently taking post exposure prophylaxis (PEP).
* Willing to provide contact information and be contacted by project staff between visits for follow up and support.
* Able to summarise the purpose of the demonstration project and their role as participants.
* Sexually active - having had sex in the last 3 months
Specific eligibility criteria for each project population are as follows:
* MSM: Age 18 and above; Self-reported anal sex with a man
* FSW: Age 18 and above; Self-identification as a sex worker;
* Young Women: Aged 15-29 ;Among young women aged 15-17, a test of understanding will also be administered to further determine their eligibility.
Exclusion Criteria:
* HIV positive
* Breastfeeding
* HIV positive
* Women above 29 years
* Those who fail test of understanding
* Those who do not meet the score cut-off on PrEP screening tool
* Not sexually active
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT02755350
Study Brief:
Protocol Section:
NCT02755350