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NOT YET RECRUITING
NCT07895823
PHASE4

Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care. Participants: 40 adult men and women living with HIV will be enrolled Procedures (methods): This is a pilot, open-label study to evaluate the acceptability, feasibility, and virologic impact of field-based LA-CAB-RPV for PWH who are out of care. This study will enroll 40 participants who accept field-based LA-CAB-RPV, targeting \>50% who reside in rural or semi-rural counties. Participants will be followed for 7 months, with duration of follow-up selected based on the FDA approved every 2 month LA-CAB-RPV injection schedule for virally suppressed patients, aligning with the 5th injection for an every two-month cycle

Official title: IGHID 12616 - Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy (RELAI) - The RELAI Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2027-01

Completion Date

2028-09

Last Updated

2026-10-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

Field-based LA-CAB/RPV

Participants will receive their first does of long-acting cabotegravir 600 mg and rilpivirine 900 mg by separate intramuscular gluteal injections on Day 0 in a secure, community-based location of their choosing (such as their home). Additional field-based injections will be available at Week 4, and then every 2 months at Weeks 12, 20, and 28, though participants can instead choose to receive injections in the clinic instead.

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States