HIV Infections Clinical Trial
Official title:
AURORA Study-A Transformative Approach Utilizing Behavioral Economics, Education, and Data Science to Support Patients Initiating PrEP With Retention-in-care and Medication Persistence
NCT number | NCT06072443 |
Other study ID # | 220084 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 30, 2023 |
Est. completion date | June 30, 2025 |
This study is designed to test the hypothesis that, compared to oral PrEP, use of CAB-LA in underserved populations in a real-world setting supported by a digital health companion program will be associated with greater medication adherence, persistence, retention-in-care, and improved PROs. Patients in the study will receive current standard care for HIV prevention and be offered enrollment in the digital health companion program. Goal of the study is to evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Initiation 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 |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia Health Right | Charleston | West Virginia |
Lead Sponsor | Collaborator |
---|---|
WV Health Right, Inc. | ViiV Healthcare |
United States,
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Huang YA, Tao G, Smith DK, Hoover KW. Persistence With Human Immunodeficiency Virus Pre-exposure Prophylaxis in the United States, 2012-2017. Clin Infect Dis. 2021 Feb 1;72(3):379-385. doi: 10.1093/cid/ciaa037. — View Citation
Keyes J, Crouse EC, DeJesus E, Rolle CP. Determinants of pre-exposure prophylaxis (PrEP) persistence in a high-risk population in Central Florida. J Investig Med. 2021 Feb;69(2):397-401. doi: 10.1136/jim-2020-001352. Epub 2020 Dec 1. — View Citation
Klein H, Washington TA. The Pre-Exposure Prophylaxis (PrEP) Stigma Scale: Preliminary findings from a pilot study. Int Public Health J. 2019;11(2):185-195. — View Citation
Krakower D, Maloney KM, Powell VE, Levine K, Grasso C, Melbourne K, Marcus JL, Mayer KH. Patterns and clinical consequences of discontinuing HIV preexposure prophylaxis during primary care. J Int AIDS Soc. 2019 Feb;22(2):e25250. doi: 10.1002/jia2.25250. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EFFICACY: Medication Adherence | Medication adherence will be calculated as the percentage of patients adherent to PrEP at months 3 and at the end of the study. The adherence percentages will be assessed by using WV Pharmacy dispensement data for the CAB-LA and Oral PrEP cohorts. Adherence will be assessed by calculating the medication possession ratio for Oral PrEP to quantify the number of oral PrEP doses missed and the percentage of participants who missed one or more injections or received injections outside the 7 day window for the target date of their CAB-LA injection. The final calculation will represent the percentage of patients in each cohort who were adherent to all prescribed PrEP doses. | 12-months | |
Secondary | EFFICACY: Retention in Care | Retention in care will be calculated in patients receiving CAB-LA vs oral PrEP as the percentage of patients with an electronic medical record documented clinic visit within 30 days of their scheduled visit at months 3, 9 and 12 for the Oral PrEP cohort and at months 3, 9, and 11 for the CAB-LA cohort. The final calculation will represent the percentage of patients in each cohort who completed all scheduled clinic visits. | 12-months | |
Secondary | SATISFACTION: Patient Experiences with PrEP | Patient experiences with PrEP medications will be assessed through a questionnaire with patients selecting from a 5-point scale ranging "very dissatisfied" to "very satisfied" in 6 question domains. Percentages of patient reported satisfaction will be compared between Oral PrEP and CAB-LA cohorts. | 12-months | |
Secondary | QUALITY OF LIFE: Patient Experiences with PrEP-related stigma | Patient experiences with PrEP-related stigma will be assessed through a questionnaire with patients selecting from a 5-point scale ranging "completely disagree" to "completely agree" in 11 question domains. Percentages of patient reported agreement will be compared between Oral PrEP and CAB-LA cohorts. | 12-months | |
Secondary | SATISFACTION: Patient Experiences with mobile App | Patient experiences with mobile App will be assessed through a questionnaire with patients selecting from a 5-point scale ranging "5=completely disagree" to "1= completely agree" in 4 question domains. Percentages of patient reported agreement will be compared between Oral PrEP and CAB-LA cohorts. | 12-months | |
Secondary | ACCEPTABILITY: Provider Acceptability of Intervention Measure (AIM) | Provider experiences with mobile App intervention will be assessed through a questionnaire with providers selecting from a 5-point scale ranging "5=completely disagree" to "1= completely agree" in 4 question domains. Percentages of provider reported agreement will be calculated into percentages for each answer choice. | 12-months | |
Secondary | ACCEPTABILITY: Provider Intervention Appropriateness Measure (IAM) | Provider experiences with CAB-LA care will be assessed through a questionnaire with providers selecting from a 5-point scale ranging "5=completely disagree" to "1= completely agree" in 4 question domains. Percentages of provider reported agreement will be calculated into percentages for each answer choice. | 12-months | |
Secondary | FEASIBILITY: Provider Feasibility of Intervention Measure (FIM) | Provider experiences with feasibility of CAB-LA care will be assessed through a questionnaire with providers selecting from a 5-point scale ranging "5=completely disagree" to "1= completely agree" in 4 question domains. Percentages of provider reported agreement will be calculated into percentages for each answer choice. | 12-months |
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