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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05281393
Eligibility Criteria:
Phase 1A:
Inclusion criteria:
* PrEP providers serving YMSM from healthcare and community-based organizations located in Los Angeles County or PrEP Navigators similarly employed by healthcare and community-based organizations that deliver PrEP services to YMSM.
* \>18 years of age
Exclusion criteria:
* Not a PrEP provider or navigator serving YMSM from healthcare and community-based organizations located in Los Angeles County
* under 18 years of age
Phase 1B and Phase 2:
Inclusion criteria:
* 16-26 years old
* cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
* identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
* identify as White/Caucasian, Black/African American, Latinx, Asian-Pacific Islander, Indigenous, Native American or mixed-race
* living in the Los Angeles metro area
* have daily access to an iOS/Android smartphone and/or tablet with internet access
* know their HIV status and are HIV negative at time of enrollment.
Exclusion Criteria:
* is younger than or older than 16- to 26-years
* not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
* does not identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
* does not identify as White/Caucasian, Black/African American, Latinx, Asian-Pacific Islander, Indigenous, Native American or mixed-race
* does not report living in the Los Angeles metro area
* is non-English speaking
* does not have daily access to an iOS/Android smartphone and/or tablet with internet access
* is a person living with HIV
* for Phase 2 only, participants will be excluded if they participated in the Phase 1B focus groups
Phase 3:
Inclusion criteria:
* 16-26 years old
* cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
* identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
* identify as White/Caucasian, Black/African American, Hispanic/Latino/Latinx, or mixed-race
* living in the Los Angeles metro area
* have daily access to an iOS/Android smartphone and/or tablet with internet access
* report having insertive and/or receptive anal sex in the previous 6 months or report a positive STI result in the previous 6 months
* not currently on PrEP and no plan to start/restart PrEP in the following 7 days
* not currently enrolled in another HIV prevention study
Exclusion criteria:
* is younger than or older than 16- to 26-years
* not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
* does not identify as gay, bisexual, or some other same-sex identity, and/or does not report having had sex with anyone with a penis during the previous 12 months
* does not identify as White/Caucasian, Black/African American, Hispanic/Latino/Latinx, or mixed-race
* does not report living in the Los Angeles metro area
* is non-English speaking
* is a person living with HIV (self-reported)
* does not report insertive and/or receptive anal sex in the previous 6 months or does not report a positive STI result in the previous 6 months
* does not have daily access to an iOS/Android smartphone and/or tablet with internet access
* is currently on PrEP or has plans to start/restart PrEP in the following 7 days; and 11) is currently enrolled in another HIV prevention study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
26 Years
Study:
NCT05281393
Study Brief:
Protocol Section:
NCT05281393