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NCT05281393Completed

PrEP2Prevent An Online PrEP Navigation and Activation Intervention

PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, Trans and Non-Binary Youth (PrEP2Prevent HIV)

Source: ClinicalTrials.gov · Last updated 9 Feb 2024

Brief summary (registry, in English)

* 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

Status (registry)
Completed
Study type
Interventional
Enrollment
150 (actual)
First submitted
6 Jan 2022
Start date
28 Jan 2021
Primary completion date
20 Jun 2023
Lead sponsor
Children's Hospital Los Angeles
Diseases
HIV
NCT number
NCT05281393

What you commit to

  • Study type: Interventional
  • Participants enrolled: 150
  • From 28 Jan 2021 to the primary completion date, 20 Jun 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 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
  • 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.

Other illness

  • is a person living with HIV
  • is a person living with HIV (self-reported)

Age

  • under 18 years of age
    • Phase 1B and Phase 2:
  • is younger than or older than 16- to 26-years
  • is younger than or older than 16- to 26-years

Other

  • Not a PrEP provider or navigator serving YMSM from healthcare and community-based organizations located in Los Angeles County
  • not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
  • 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
  • for Phase 2 only, participants will be excluded if they participated in the Phase 1B focus groups
    • Phase 3:
  • not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
  • 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
  • does not have daily access to an iOS/Android smartphone and/or tablet with internet access

Who the study is looking for

  • 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
  • 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.
  • 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

Criteria the registry did not label

  • Phase 1A:

Age in the registry: 16 years to 26 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital Los Angeles
Coordinator of this site? Confirm its status		Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.