Recruiting

PrEP

Sponsor:

WV Health Right, Inc.

Code:

NCT06072443

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Digital Health Companion (mobile App)

Study Details

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

Study ID

NCT06072443

Start date

Nov 30, 2023

Status verified date

Jun, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

105 participants

Anticipated

Interventions and Outcome Measures

Arms

CAB-LA PrEP Cohort

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

Oral PrEP Cohort

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

Interventions

Digital Health Companion (mobile App)

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

Primary outcome measure

  • EFFICACY: Medication Adherence [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Angie Settle, DNP, APRN

304-414-5930ASettle@wvhealthright.org

Rhonda Francis, CPhT, Adv

304-414-5930Rfrancis@wvhealthright.org

Locations

West Virginia Health Right

Recruiting

Charleston, West Virginia, United States, 25311

Contacts

Rhonda Francis

305-414-5930

More Information

Sponsor

WV Health Right, Inc.

Last update posted

Jun 25, 2024

Last verified

Jun, 2024

Keywords

  • PrEP
  • HIV Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by WV Health Right, Inc. on 2024-06-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.