Clinical trial NCT05281393: PrEP2Prevent An Online PrEP Navigation and Activation Intervention
Official title: PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, Trans and Non-Binary Youth (PrEP2Prevent HIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: PrEP
Mobile Health
LGBTQ
Transgender
Adolescent
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Florida State University
First posted: 2022-03-16
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: PREVENTION

Brief 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

Detailed description: The U.S. Department of Health and Human Services (HHS) has set a goal to end the HIV epidemic by the year 2030, which is well within reach given the availability of antiretrovirals that effectively prevent and treat HIV. But success can only be achieved if targeted approaches are implemented with at-risk populations to address known barriers of engagement along the pre-exposure prophylaxis (PrEP) and HIV care continua. In response, obtained funding from NIH, using the R34 mechanism, with the goal of the research being to develop and pilot test a PrEP activation, navigation and support intervention for YMSM, including young Black and Latino YMSM (B-YMSM, L-YMSM), who not only have the highest annual incidence of HIV but who are also the least likely to have ever used PrEP. There is very clear evidence demonstrating that while YMSM have high levels of knowledge about and intentions to use PrEP, few have ever used PrEP. Our own research demonstrate the urgent need for interventions that specifically target PrEP uptake while also addressing a complex array of individual (e.g., side effect concerns, substance use, depression), sociocultural (e.g., internalized homophobia, PrEP-related stigma), and structural (e.g., access to care, medication costs) barriers to PrEP uptake. Our research also demonstrates that such an intervention should include four components: 1) inclusion of PrEP and other service navigation; 2) provision of skills to address patient activation, reduce PrEP-related stigma, and increase PrEP self-efficacy; 3) peer/social support; and 4) utilize a mobile health (mHealth) platform or similar technology that supports both in-person and virtual intervention delivery (text and live video chat). Based on these findings, the investigators propose to conduct research with the following specific aims

Specific Aim 1: Conduct formative research to inform the development of a PrEP activation, navigation and support intervention, which the investigators call PrEP2Prevent. Qualitative data will be collected using structured guides from working/focus groups with YMSM, Trans, and gender non-conforming youth and during Key Informant Interviews (KII) with existing PrEP care providers/navigators. These data will inform intervention content and activation/navigation services.

Specific Aim 2: Develop and then conduct usability testing of PrEP2Prevent, including both the intervention content and mHealth delivery platform. Data from Aim 1 will inform the content and structure of intervention components to be included. During intervention development, two rounds of usability testing will be conducted with 8-10 YMSM, Trans, and gender non-conforming youth to ensure features are usable and the content is understood. Internal beta testing will be performed to assess for full technical functionality.

Specific Aim 3: Evaluate the feasibility, acceptability and preliminary efficacy of PrEP2Prevent with a racially/ethnically diverse sample of 150 (50 Non-Hispanic Whites, 50 Blacks/African American, 50 Latino/Hispanic) YMSM, Trans, gender non-conforming youth, ages 16-26 years. Participants will be randomly assigned in a 1:1 ratio to the intervention app (PrEP2Prevent) or control app (standard of care). Primary outcomes are feasibility, acceptability and preliminary efficacy. Feasibility data will include sources and rates of recruitment/retention, barriers and facilitators to recruitment/retention, engagement with PrEP navigator both in-person and via mHealth platform, as well as paradata on the mHealth platform use (e.g., number of log-ins, time spent, chatroom/text-based discussions). Acceptability will be assessed using a survey with validated measures at intervention completion. Preliminary efficacy will include linkage to PrEP services and PrEP uptake, these data will be collected at baseline and at 3- and 6-months following completion of the intervention. Mediators/moderators will include PrEP self-efficacy, PrEP stigma, and patient activation. The findings from this research will inform further refinements to the intervention and provide estimates of possible intervention effect sizes (group means, SDs) for a future randomized controlled trial (RCT). The funded research is highly significant, timely and innovative. Its innovation lies in the fact that it: a) targets an intervention for YMSM where it is most needed - e.g., on PrEP uptake; b) recognizes that YMSM require tools and support to successfully navigate PrEP services; and c) uses mHealth to deliver the intervention. Moreover, the intervention can be used for both engagement and re-engagement in PrEP uptake for YMSM who cycle in and out of PrEP care. Further, the intervention is potentially easily adaptable and transferable to address other critical PrEP and HIV needs (e.g., uptake of long-acting PrEP and antiretroviral therapy \[ART\]).

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.

Primary outcomes:
measure: Formative Research - PrEP Provider and Navigator Interviews
timeFrame: 90 minute one time interview
measure: Formative Research - Youth Working Groups
timeFrame: 4 week duration
measure: Pre-Pilot Mobile App Usability Testing
timeFrame: 4 week duration
measure: Patient Navigation Feasibility
timeFrame: 6 Months
measure: Patient Navigation Acceptability
timeFrame: 6 Months
measure: PrEP Uptake
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Michele D Kipke, PhD
role: PRINCIPAL_INVESTIGATOR
References: