MedTrace Logo

Combined Injectable Treatment for HIV and OUD

NCT05991622 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Combined LAI Treatment: Cabenuva and Sublocade

A preliminary test of the combined LAI treatment will be conducted with a total of 30 individuals diagnosed with HIV and OUD that meet all other study inclusion criteria. Treatment will take place primarily at TMH IC (n=30). Participants deemed fit for the study (per recommendation by TMH IC staff and subsequent medical chart review) will receive the combined LAI treatment (described below), and complete follow-up assessments at 1-, 3-, and 6-months following initiation of injectable medication. Of the 30 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. We will also elicit feedback from clinic staff and other key stakeholders regarding the delivery of the clinical protocol and other implementation factors

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Josiah D Rich, MD · Rhode Island Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-08-27
Completion
2026-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05991622 on ClinicalTrials.gov