Transformative approach to support PrEP medication persistence
AURORA Study-A Transformative Approach Utilizing Behavioral Economics, Education, and Data Science to Support Patients Initiating PrEP With Retention-in-care and Medication Persistence
This study is testing if a long-acting injectable HIV prevention medication helps people stick to their treatment better than the daily pill, especially for those who may not have easy access to healthcare.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | WV Health Right, Inc. Academic / other |
| Locations | 1 site (Charleston, West Virginia) |
| Trial ID | NCT06072443 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of CAB-LA compared to oral PrEP in enhancing medication adherence and persistence among underserved populations. Participants will receive standard HIV prevention care and have the option to engage with a digital health companion program designed to support their adherence to PrEP. The study will assess various outcomes, including retention-in-care and patient-reported outcomes, while also exploring clinician perspectives and implementation barriers. The research employs a hybrid effectiveness-implementation design to gather comprehensive data on the real-world application of these interventions.
Who should consider this trial
Good fit: Ideal candidates include individuals initiating or currently using PrEP with CAB-LA or oral options, who have access to a smartphone.
Not a fit: Patients who are HIV positive or receiving PrEP care outside of the designated health system will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve medication adherence and retention in care for individuals at risk of HIV.
How similar studies have performed: Other studies have shown promising results with similar digital health interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Initiation of or current user of PrEP with CAB-LA, daily FTC/TDF, or daily FTC/TAF prescribed in accordance with the WVHR standard of care practices (based practices on CDC PrEP 2021 Clinical Practice Guidelines) by a licensed HCP * PrEP dispensed by WVHR pharmacy * Access to a smart phone Exclusion Criteria: * Receiving HIV PrEP care outside of WVHR * Positive HIV diagnosis * Contraindication to oral or injectable PrEP therapy * Receiving oral bridging therapy prior to injectable PrEP therapy
Where this trial is running
Charleston, West Virginia
- West Virginia Health Right — Charleston, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Angie Settle, DNP, APRN
- Email: ASettle@wvhealthright.org
- Phone: 304-414-5930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.