drugset / Trial / NCT05991622

Combined Injectable Treatment for HIV and OUD

NCT05991622

Phase 2 Withdrawn Rhode Island Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is study seeks to evaluate perspectives of a combined injectable treatment for HIV and OUD. Specifically, with the development of new long-acting medications such as cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine (XR-B) there is a need to better understand factors that influence the delivery and uptake of this type of treatment. The current study seeks to conduct a single-arm open pilot trial of a clinical protocol and implementation approach for the combined HIV/OUD LAI treatment. Participants will include patients receiving treatment at TMH IC (n=30) and clinic staff (n=5-10). Participants will complete a baseline survey, receive the combined LAI treatment, and complete follow-up assessments at 1-, 3-, and 6-months following initiation of injectable medication. Of the 40 participants, 25 will be purposefully selected to engage in qualitative interviews to assess the strengths and limitations of the clinical protocol and combined treatment as well as describe their reasons for LAI uptake or discontinuation.

Timeline

Start
2022-04-01
Primary completion
2025-08-27
Completion
2026-02-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified
Subject Cabotegravir Small molecule
Subject Rilpivirine Small molecule