NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Rhode Island Hospital
Conditions: Human Immunodeficiency Virus, Opioid Use Disorder
Interventions: Combined LAI Treatment: Cabenuva and Sublocade
Countries: United States
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.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Exclusion Criteria: * 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
- Providence, Rhode Island, United States