ACTIVE_NOT_RECRUITING

Combined Injectable Treatment for HIV and OUD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder

Quick Facts

Study Start:2022-04-01
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05991622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-65 years of age
  2. * HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay
  3. * Current diagnosis of OUD according to DSM-5
  4. * Able to understand and speak English and to provide written and verbal informed consent
  1. * Currently pregnant, breastfeeding, planning to become pregnant or breastfeed during the study period
  2. * Coinfection of Hepatitis B or plans to get treated for Hepatitis C during the study period

Contacts and Locations

Principal Investigator

Josiah D Rich, MD
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Josiah D Rich, MD, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Human Immunodeficiency Virus
  • Opioid Use Disorder