PROJECT SUMMARY
HIV incidence is unacceptable with the availability of highly effective, evidenced-based methods of treatment
and prevention. Biomedical HIV prevention has extended beyond pill-based strategies to now include long-
acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) via cabotegravir administered by intramuscular
injection in the gluteus muscle every 8 weeks. It is heralded as a “game-changer,” but implementation of LAI-
PrEP is unjustifiably suboptimal. LAI-PrEP has high consumer demand based on priority populations’
preferences, yet few providers are currently prescribing cabotegravir for LAI-PrEP. Importantly, LAI-PrEP has
potential to reduce disparities in PrEP use among the most vulnerable based on preliminary evidence
indicating better HIV protection for Black cisgender men and transgender women who have sex with men
compared to daily oral PrEP, and long-acting antiretroviral therapy was found to be particularly effective in
helping patients with unstable housing, mental illnesses, and substance use disorder achieve HIV viral
suppression. Implementation research is needed to support further roll-out of PrEP as an umbrella prevention
strategy, yet LAI-PrEP has unique implications for clinical practice that will not easily fit within implementation
strategies for oral PrEP. A better understanding of how these specific factors impact roll-out is needed to
address enduring barriers and guide implementation considerations. As such, this proposal aims to: (1) identify
enduring barriers and facilitators to LAI-PrEP implementation in the U.S., (2) determine optimal implementation
strategies for LAI-PrEP in partnership with stakeholders, and (3) pilot an implementation strategy within two
outpatient clinics in Milwaukee, Wisconsin. To help guide this formative work, the team leverages the
Consolidated Framework for Implementation Research to understand determinants of LAI-PrEP
implementation and uses two Expert Recommendations for Implementing Change strategies rated with high
feasibility and high importance to maximize potential impact in supporting LAI-PrEP roll-out. The investigators
propose an action-oriented project using principles of community-based participatory research to engage and
collaborate with providers, community members, and stakeholders to support implementation. Preliminary
impact of LAI-PrEP implementation will be evaluated using RE-AIM, assessing Reach, Effectiveness,
Adoption, Implementation, and Maintenance via electronic medical records review, survey, and exit interviews.
Exit interviews will also determine feasibility, acceptability, and appropriateness of the implementation strategy.
This projects’ target on LAI-PrEP is timely, uses an innovative sampling approach to study providers’
perspectives, and is positioned to bring forth paradigm-shifting approaches to incorporate LAI-PrEP into clinical
practice. This proposal is led by an experienced early-stage investigator in collaboration with a multidisciplinary
investigative team, compliments research supporting oral PrEP implementation, and sets the stage for larger
scale implementation efforts to enhance integration of LAI-PrEP into clinical practice.