Combined Injectable Treatment for HIV and OUD
Key facts
- Who runs it
- Rhode Island Hospital
- Where
- Providence, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 1 Apr 2022
- Ended
- 13 Feb 2026
- Type of study
- Interventional
- Treatments tested
- Combined LAI Treatment: Cabenuva and Sublocade
- Record updated
- 18 February 2026
- Why it stopped
- The study was initiated but no participants were enrolled.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Coinfection of Hepatitis B or plans to get treated for Hepatitis C during the study period
- Currently pregnant, breastfeeding, planning to become pregnant or breastfeed during the study period
Where in United States
- Rhode Island HospitalProvidence, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Preliminary Test of Combined LAI TreatmentTreatment being tested
The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.
Treatment: Combined LAI Treatment: Cabenuva and Sublocade
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder
- Record updated
- 18 February 2026