PrEP2Prevent An Online PrEP Navigation and Activation Intervention

NCT05281393 | Completed DMC

• 1 other identifier: CHLA-20-00596
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections

Keywords

PrEP; Mobile Health; LGBTQ; Transgender; Adolescent

Outcome Measures

Primary Outcomes (6)

• Formative Research - PrEP Provider and Navigator Interviews

  16 qualitative interviews with PrEP Providers and Navigators will be recorded and transcribed. Using existing theory or prior research, researchers will begin by identifying key concepts or variables as initial coding categories. MAXQDA will provide support in the coding and the ability to better understand and identify emergent themes and conceptual frameworks through network maps. These maps may include: 1) components most relevant for an intervention; 2) effective strategies for activation, motivation and engagement; 3) attitudes and challenges related to PrEP; 4) differences in needs, challenges and expectations across ethnic groups; and/or 5) most relevant/important mHealth features. The maps will then be analyzed to identify the relationships between constructs related to the PrEP cascade and relevant components of an online PrEP navigation model.

  90 minute one time interview

• Formative Research - Youth Working Groups

  Two working groups, each with 6-10 racial/ethnically diverse YMSM, Trans, and gender non-conforming youth will be conducted. Working groups will meet weekly (or bi-weekly) for up to four sessions. Participants will be guided in discussions on a variety of topics, including 1) experiences with perceptions of PrEP; 2) understanding how YMSM, Trans, and gender non-conforming youth access care; 3) factors that impact uptake of and use to PrEP; 4) risk perceptions and health as a priority; 5) preferred modality (mobile app, web-based, online chat/video) and frequency of navigation activities; and 6) strategies to increase patient activation self-efficacy, advocacy, motivations). A baseline survey about personal health, health history and technology will be given to participants before their first session. At the end of each session, a satisfaction survey will be given to participants to fill out.

  4 week duration

• Pre-Pilot Mobile App Usability Testing

  Recruitment of 8-10 racial/ethnically diverse YMSM, Trans, and gender non-conforming youth. Study participants will participate in one online focus group session to download and review the app, one virtual session with the live PrEP Navigator in either chat or video conference format, and a one-on-one exit interview with a research staff member about their app feedback. Participants will also be asked to fill out Pre-Test and Post-Test survey measures to assess app feedback and general usability. Members of the working groups will be invited to use PreP2Prevent over a 2-week period acting in the role of participants. Beta testing will allow for a full assessment of both the technical functionality of the mHealth platform, and will help finalize pilot test procedures. This will include engaging with the peer navigator in two "mock" navigation sessions (one text-based and one video-based).

  4 week duration

• Patient Navigation Feasibility

  Source: Study logs, Post-navigation satisfaction survey Description: # navigation sessions attended/missed, delivery modality (in-person, text, video); # contacts navigator made to schedule each session, # referrals made/attended. Feasibility defined as at least 50% of individuals attending on average \>2 sessions over the 3-month intervention period and a mean post-navigation satisfaction survey score of 4 or higher.

  6 Months

• Patient Navigation Acceptability

  Source: In-app survey Description: A brief satisfaction assessment (5 questions) will be administered at the end of each navigation session to identify challenges experienced by the participant, the most and least helpful aspects of the session, challenges using the system, satisfaction with information provided, and any additional needs the participant had that the navigator was not able to address.

  6 Months

• PrEP Uptake

  Source: Self report Description: PrEP usage quantitative measures at 3 and 6 months Source: Ursure Description: Point-of-care rapid urine test of tenofovir as a biological marker of recent (within 48 hours) PrEP use

  6 Months

Study Arms (2)

Control

NO INTERVENTION

Access to mobile health platform for resources and information about PrEP

Experimental

EXPERIMENTAL

Access to mobile health platform for resources and information about PrEP plus sessions with peer health support navigator, social app interactions, goal setting capabilities

Behavioral: PrEPresent

Interventions

PrEPresent BEHAVIORAL

PrEP2Prevent is being done in several phases (parts) to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM), trans youth and non-binary youth in Los Angeles. It targets an intervention for these young people where they need it most - on PrEP uptake. PrEP stands for pre-exposure prophylaxis.

Also known as: PrEP2Prevent

Experimental

Eligibility Criteria

• Age: 16 Years - 26 Years
• Gender Eligibility Details: Cismale, Transgender, non-binary
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.
• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Florida State University: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (1)

• Stocks JB, Calvetti S, Rosso MT, Slay L, Kipke M, Puentes M, Hightow-Weidman LB. Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 29;12:e50866. doi: 10.2196/50866.

  PMID: 37773616 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Michele D Kipke, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: March 16, 2022
• Study Start: January 28, 2021
• Primary Completion: June 20, 2023
• Study Completion: January 3, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: 8/1/2023-7/31/2026
• Access Criteria: Describe how to access this data. Email requests can be submitted to the Senior Programs Manager Lindsay Slay at lslay@chla.usc.edu or PI Michele Kipke at mkipke@chla.usc.edu. Templates will be provided for the publication plan and data use agreement.

Locations

US (1)