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 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT04982250
Eligibility Criteria:
Inclusion Criteria:
For peer providers (qualitative data, pilot):
* Age ≥16 to 24 years\*
* Female
* Have been on PrEP for a minimum of three months
* Good adherence to PrEP (i.e., self-report take PrEP all the time)
* Willing to disclose PrEP use to their peers
* Able to identify up to 4 peers at risk of HIV infection
* Willing to participate in training with study counselors on PrEP referral and HIVST use
* Willing to refer peers to PrEP and deliver HIVSTs
* Able and willing to provide written informed consent
* Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
For peer providers (cRCT):
* Age ≥16 to 24 years\*
* Female
* Must have refilled or initiated PrEP (i.e., been dispensed PrEP)
* Not currently enrolled in an HIV study
* Able to identify up to 4 peers with recent self-reported behaviors associated with risk of HIV acquisition
* Willing to participate in training with study counselors on PrEP referral and HIVST use
* Willing to refer peers to PrEP and deliver HIVSTs
* Able and willing to provide written informed consent
* Willing to provide contact information for follow-up
* Willing to engage in all research activities including completion of questionnaires
* Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
For peer clients (pilot, RCT):
* Age ≥16 to 24 years\*
* Female
* Referred by peer (i.e., a PrEP users) to initiate PrEP
* Able and willing to provide informed consent
* NOTE: We will only enroll young women ≥16 to 17 years into the study if they are emancipated minors and thus able to legally provide consent for participation in research. Kenyan law acknowledges women ages 14 to 17 who have become pregnant as emancipated minors. The PHRD site/UW collaboration has successfully enrolled emancipated minors into a number of prior studies, including PrEP clinical trials. In addition, Kenya's national policy guidelines explicitly permit PrEP use in this age group.
Exclusion Criteria:
For peer providers (qualitative data, pilot):
* Age ≥16 or \>24 years
* Male
* Have not used PrEP for a minimum of three months
* Not willing to disclose PrEP use to their peers
* Not able to identify up to 4 peers at risk of HIV infection
* Not willing to participate in training with study counselors on PrEP referral and HIVST use
* Not willing to refer peers to PrEP and deliver HIVSTs
* Not able and willing to provide written informed consent
For peer providers (cRCT):
* Age ≥16 or \>24 years
* Male
* Have not used PrEP
* Currently enrolled in an HIV study
* Not able to identify up to 4 peers at risk of HIV infection
* Illiterate
* Not willing to participate in training with study counselors on PrEP referral and HIVST use
* Not willing to refer peers to PrEP and deliver HIVSTs
* Not able and willing to provide written informed consent
For peer clients (pilot, cRCT):
* Age ≥16 or \>24 years
* Male
* Not referred by peer (i.e., a PrEP users) to initiate PrEP
* Not able and willing to provide written informed consent
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT04982250
Study Brief:
Protocol Section:
NCT04982250