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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT04044235
Eligibility Criteria:
Inclusion Criteria:
Eligibility criteria for the cross-sectional study
* Female
* Consent to be counselled and tested for HIV
* Between 18 and 24 years old
* Ongoing HIV risk according to the risk Assessment guide
* Participated in the cross-sectional screening study or meets the eligibility criteria for the cross-sectional study
* Willing to provide written informed consent to participate in the HIV incidence study
* Accesses services at a mobile or fixed clinic in the defined catchment area
* Not planning to relocate in the next 12 months Eligibility criteria for the prospective PrEP for AGYW
* Participated in the cross-sectional study
* HIV-negative
* Answers yes to any two questions from the PrEP screening tool
* Willing and able to adhere to daily PrEP
* Willing to provide written informed consent to participate in the PrEP study
* Accesses services at a mobile or fixed clinic in the defined catchment area
* Not planning to relocate in the next 12 months
Eligibility criteria for focus group discussions for PrEP providers
* Provided PrEP for at least 3 months
* Trained nurse
* Orientated in PrEP and study procedures
Exclusion Criteria:
Exclusion criteria for the prospective HIV incidence phase
• HIV positive
Exclusion criteria for PrEP for AGYW
* Under 18 years or older than 24 years at enrollment (including AGYW aged 24 years at enrolment)
* Breastfeeding women
* Already taking oral or injectable PrEP through another study
* Current or past history of renal or liver disease
* Clients on multi-drug resistant tuberculosis (MDR-TB) medications
* Signs of acute HIV infection. The client would be asked to return after 3 months for a re-evaluation
* FSW \<35kg
* Known allergy to tenofovir disoproxil fumarate (TDF) and/or emtricitabine (FTC);
* Unwilling or unable to return for 3-monthly HIV testing, counselling and safety monitoring visits or planning to relocate to another geographic area during the period of the study.
* Blood creatinine clearance (Cr Cl) \<60ml/min
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT04044235
Study Brief:
Protocol Section:
NCT04044235