AURORA Study-A Transformative Approach to Support PrEP Medication Persistence

NCT06072443 | Recruiting

• 1 other identifier: 220084
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

PrEP; HIV Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• EFFICACY: Retention in Care

  12-months

• SATISFACTION: Patient Experiences with PrEP

  12-months

• QUALITY OF LIFE: Patient Experiences with PrEP-related stigma

  12-months

• SATISFACTION: Patient Experiences with mobile App

  12-months

• ACCEPTABILITY: Provider Acceptability of Intervention Measure (AIM)

  12-months

Study Arms (2)

CAB-LA PrEP Cohort

Prescribed CAB-LA PrEP as standard of care or current user of CAB-LA PrEP

Behavioral: Digital Health Companion (mobile App)

Oral PrEP Cohort

Prescribed oral PrEP as standard of care or current user of oral PrEP

Behavioral: Digital Health Companion (mobile App)

Interventions

Digital Health Companion (mobile App) BEHAVIORAL

Participants will complete education modules, health literacy evaluations, and PRO assessments in the Digital Health Companion.

CAB-LA PrEP Cohort; Oral PrEP Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving HIV prevention care at WVHR.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• WV Health Right, Inc.: lead
• ViiV Healthcare: collaborator

Study Sites (1)

West Virginia Health Right

Charleston, West Virginia, 25311, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 33527117 BACKGROUND

• 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.

  PMID: 33262130 BACKGROUND

• Spinelli MA, Scott HM, Vittinghoff E, Liu AY, Gonzalez R, Morehead-Gee A, Gandhi M, Buchbinder SP. Missed Visits Associated With Future Preexposure Prophylaxis (PrEP) Discontinuation Among PrEP Users in a Municipal Primary Care Health Network. Open Forum Infect Dis. 2019 Feb 26;6(4):ofz101. doi: 10.1093/ofid/ofz101. eCollection 2019 Apr.

  PMID: 30949540 BACKGROUND

• 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.

  PMID: 30768762 BACKGROUND

• Weitzman PF, Zhou Y, Kogelman L, Rodarte S, Vicente SR, Levkoff SE. mHealth for pre-exposure prophylaxis adherence by young adult men who have sex with men. Mhealth. 2021 Jul 20;7:44. doi: 10.21037/mhealth-20-51. eCollection 2021.

  PMID: 34345621 BACKGROUND

• Garrison LE, Haberer JE. Pre-exposure Prophylaxis Uptake, Adherence, and Persistence: A Narrative Review of Interventions in the U.S. Am J Prev Med. 2021 Nov;61(5 Suppl 1):S73-S86. doi: 10.1016/j.amepre.2021.04.036.

  PMID: 34686294 BACKGROUND

• Woodcock A, Bradley C. Validation of the HIV treatment satisfaction questionnaire (HIVTSQ). Qual Life Res. 2001;10(6):517-31. doi: 10.1023/a:1013050904635.

  PMID: 11789552 BACKGROUND

• Arnould B, Gilet H, Patrick DL, Acquadro C. Item Reduction, Scoring, and First Validation of the ACCEPTance by the Patients of their Treatment (ACCEPT(c)) Questionnaire. Patient. 2017 Feb;10(1):81-92. doi: 10.1007/s40271-016-0187-7.

  PMID: 27456210 BACKGROUND

• 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.

  PMID: 32089789 BACKGROUND

• Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.

  PMID: 30984733 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Angie Settle, DNP, APRN

CONTACT

304-414-5930; ASettle@wvhealthright.org

Rhonda Francis, CPhT, Adv

CONTACT

304-414-5930; Rfrancis@wvhealthright.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: October 10, 2023
• Study Start: November 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)