Combined Injectable Treatment for HIV and OUD

Withdrawn before enrolling · Phase 2

Conditions studied: Human Immunodeficiency Virus, Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT05991622

Run by

Rhode Island Hospital

People needed

0

Starts

2022-04-01

Expected to finish

2026-02-13

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-65 years of age
• HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay
• Current diagnosis of OUD according to DSM-5
• Able to understand and speak English and to provide written and verbal informed consent

You may not qualify if…

• Currently pregnant, breastfeeding, planning to become pregnant or breastfeed during the study period
• Coinfection of Hepatitis B or plans to get treated for Hepatitis C during the study period

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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