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).