CompletedNot Applicable

PrEP2Prevent An Online PrEP Navigation and Activation Intervention

United States150 participantsStarted 2021-01-28

Plain-language summary

* The goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, is to develop and test a method for supporting access to an HIV prevention medication called Pre-Exposure Prophylaxis (PrEP) in young men who have sex with men and young transgender and non-binary individuals. The main questions it aims to answer are: * What are some of the experiences and barriers providers have seen regarding this population accessing PrEP * Using information gathered from PrEP providers and navigators, develop a mobile health platform and PrEP related content that will be tested by members of the population to see if the features are usable and the content is understandable. * Enroll 150 study participants to see if utilizing the mobile health platform and receiving supportive sessions related to motivation and barriers to accessing PrEP is achievable. * Participants will * Be given access to the mobile health Platform called PrEPresent, which provides them with access to prevention related content, the ability to schedule with a patient navigator and create customizable goals * Complete a baseline, 3 month and 6 month assessment about personal health, health history and technology, along with a PrEP adherence rapid urine test * Complete up to 4 sessions to assist participants in the intervention group with discussing any barriers to accessing PrEP

Who can participate

Age range

16 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Americ…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Formative Research - PrEP Provider and Navigator Interviews

Timeframe: 90 minute one time interview

Formative Research - Youth Working Groups

Timeframe: 4 week duration

Pre-Pilot Mobile App Usability Testing

Timeframe: 4 week duration

Patient Navigation Feasibility

Timeframe: 6 Months

Patient Navigation Acceptability

Timeframe: 6 Months

PrEP Uptake

Timeframe: 6 Months

Trial details

NCT IDNCT05281393

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-20

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range

16 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Formative Research - PrEP Provider and Navigator Interviews

Timeframe: 90 minute one time interview

Formative Research - Youth Working Groups

Timeframe: 4 week duration

Pre-Pilot Mobile App Usability Testing

Timeframe: 4 week duration

Patient Navigation Feasibility

Timeframe: 6 Months

Patient Navigation Acceptability

Timeframe: 6 Months

PrEP Uptake

Timeframe: 6 Months