Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05281393
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 \[ART\]).
Study:
NCT05281393
Study Brief:
Protocol Section:
NCT05281393