This is a revised (A1) R34 application entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, which proposes to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM). This population has the highest annual incidence of HIV and is also the least likely to have ever used PrEP. Our own data with a large cohort of YMSM indicates that while 90% have heard about PrEP and 86% meet CDC?s eligible criteria for PrEP, only 23% have ever used PrEP and 8% are currently on PrEP. In this same cohort, 26% tested positive for one or more sexually transmitted infections (STIs) and the HIV seroconversion rate was 4.3% during a 2 years period. Thus, it is very clear that there is an urgent need for interventions that specifically target PrEP uptake while also addressing a complex array of individual (e.g. substance use, depression), sociocultural (e.g., PrEP- related stigma), and structural (e.g., medication costs) barriers to PrEP uptake. Based on our own research, we are proposing an intervention that includes PrEP navigation; patient activation to reduce PrEP-related stigma and increase PrEP self-efficacy; and peer/social support. The intervention will be delivered using mobile health (mHealth) or similar technology.
The specific aims are to: 1) Conduct formative research to inform the development of a PrEP activation, navigation and support intervention, which we call PrEP2Prevent. Qualitative working/focus group data will be collected from YMSM and focus groups will be conducted with PrEP care providers/navigators; 2) Develop and then conduct usability testing of PrEP2Prevent, including both the intervention content and mHealth delivery platform; and 3) Evaluate the feasibility and acceptability of PrEP2Prevent with a racially/ethnically diverse sample of 150 YMSM (ages 16-24 years). Participants will be randomly as assigned to the intervention (PrEP2Prevent) or control (standard of care) group. Primary outcomes are feasibility and acceptability. A secondary aim is to evaluate the impact of the intervention on our targeted meditating mechanisms and proximal behavioral outcomes (e.g., PrEP stigma and self- efficacy). We will also assess participants? PrEP uptake (using verified service use and a biomarker of PrEP use) to determine if there are any trends associated with participation in the intervention. Assessments will occur at baseline and at 3- (intervention completion) and 6-months. These data will provide estimates of possible intervention effect sizes (group means, SDs) for a future RCT. Implementation research will also be conducted, drawing upon the RE-AIM framework. The proposed research is highly significant, timely and innovative. It targets an intervention for YMSM where they need it most ? i.e., on PrEP uptake. It recognizes that YMSM require tools and support to successfully navigate PrEP services, and uses mHealth to deliver the intervention. Moreover, the intervention can be used to both engage and re-engage YMSM in PrEP uptake, and it can potentially be adapted to address uptake of long-acting PrEP and antiretroviral therapy (ART).
The U.S. Department of Health and Human Services (HHS) has set a goal to end the HIV epidemic by 2030, which is well within reach given the availability of antiretrovirals that effectively prevent and treat HIV. However, 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; of particular concern are young men who have sex with men who experience multiple individual, social and structural barriers to PrEP uptake. The proposed study will develop, implement and evaluate an intervention that we call PrEP2Prevent; this intervention will address these barriers and promote PrEP uptake by providing PrEP navigation and peer/social support; increasing patient activation and reducing PrEP-related stigma; and increasing PrEP self-efficacy.
