AURORA Study-A Transformative Approach Utilizing Behavioral Economics, Education, and Data Science to Support Patients Initiating PrEP With Retention-in-care and Medication Persistence

The study will evaluate the extent to which real-world use of CAB-LA for PrEP in underserved populations impacts PrEP adherence, persistence, retention-in-care, and PROs compared with oral PrEP. Additionally, the study will examine the implementation of a digital health companion program that leverages education and behavioral economics to support patients on PrEP, and assess clinician perspectives as well as barriers to, and facilitators for implementation of CAB-LA in a patient-centered medical home.

Primary Objective To evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program

Secondary Objectives Evaluate retention-in-care in patients receiving CAB-LA vs oral PrEP Evaluate PROs (including PrEP Medication Satisfaction, PrEP Acceptance, P Evaluate the acceptability, appropriateness, and helpfulness of a digital health companion program for PrEP Evaluate the acceptability, barriers to, and facilitators for implementation of CAB-LA

Study Design The research project follows a hybrid effectiveness-implementation research design, with the primary aim focused on evaluation of PrEP adherence, persistence and retention-in-care with CAB-LA compared with oral PrEP, and secondary aims focused on evaluating patient-reported outcomes (PROs), implementation of a digital health intervention to support adherence and persistence, and evaluating contextual factors around implementation of CAB-LA. The proposed study will utilize a digital health intervention with behavioral health economics and patient education from PRIME and Reciprocity to evaluate the adoption and implementation of a Digital Health Companion for PrEP adherence and persistence. The implementation aims of the study will leverage the RE-AIM framework as follows: Assessment of the digital health intervention will focus primarily on individual-level dimensions of RE-AIM, including reach and effectiveness. For example, in assessing reach of the digital health intervention, participant demographics will be compared to the intended audience to evaluate the extent to which populations with high unmet needs were engaged. Conversely, assessment of the implementation of CAB-LA will focus on system-level dimensions of RE-AIM, such as qualitative assessments of barriers to and facilitators for implementation of CAB-LA. In addition, evaluation of PROs will be informed by a review of validated instruments, including HIVSTQ (HIV Treatment Satisfaction Questionnaire), SMSQ (Study Medication Satisfaction Questionnaire), I-TAQ (Injection Treatment Acceptance Questionnaire), ACCEPT (Chronic Treatment Acceptance Questionnaire), and the PrEP Stigma Scale, with survey items tailored to evaluate PrEP acceptance, satisfaction, and perceptions of PrEP-related stigma for both the CAB-LA and oral PrEP arms.

Description of Study Procedures Before any screening procedure is performed, informed consent will be obtained. Labs will be taken at baseline and months 3, 5, 7, 9, and 11 for the CAB-LA cohort and at baseline and months 3, 6, 9, and 12 for the Oral PrEP cohort. Participants will complete a baseline evaluation and be introduced to a support group at baseline. Patients will complete assessments within the Reciprocity App. Clinicians will complete assessments outside of the app. Patients in both cohorts will complete baseline demographic surveys in month 0, patient reported outcomes (PRO) data collection set 1 in months 1, 5, and 11 and PRO data collection set 2 in months 3, 9, and 12. Patients in the CAB-LA PrEP cohort will complete persistence assessments in months 1, 3, 5, 7, 9, and 11. Patients in the Oral PrEP cohort will complete persistence assessments every month from months 1 through 12. Clinic staff will complete surveys at baseline, month 6, month 12, and at the end of the study.