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Combined LAI Treatment for HIV/AIDS and Opioid Use Disorder (CHOICE Trial)
Phase < 1
Recruiting
Led By Kirsten K Langdon, Ph.D.
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore how new long-acting HIV and opioid addiction medications may be used, and how to promote their uptake. Qualitative interviews will be conducted with stakeholders to understand attitudes, barriers, and facilitators.
Who is the study for?
This trial is for individuals aged 18-65 with HIV and opioid use disorder (OUD), who can communicate in English. They must have a confirmed HIV diagnosis and meet the criteria for OUD. Participants from RIDOC should expect to be released within 6 months. Pregnant or breastfeeding individuals, or those planning pregnancy or treatment for Hepatitis B/C during the study, cannot join.
What is being tested?
The study is testing a combined long-acting injectable treatment regimen: Cabenuva (cabotegravir with rilpivirine) for HIV and Sublocade (extended-release buprenorphine) for OUD. It involves interviews with stakeholders to understand factors affecting this treatment's delivery and acceptance over one year.
What are the potential side effects?
Potential side effects of Cabenuva may include injection site reactions, fever, fatigue, headache, muscle pain; while Sublocade might cause constipation, nausea, vomiting, headache, increased liver enzymes. Side effects vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Feasibility/Acceptability
Recruitment rates
+1 moreSecondary study objectives
HIV Risk Behavior
Overall Quality of life
Substance use
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Preliminary Test of Combined LAI TreatmentExperimental Treatment1 Intervention
The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
264 Previous Clinical Trials
68,739 Total Patients Enrolled
Kirsten K Langdon, Ph.D.Principal InvestigatorRhode Island Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Hepatitis B or plan to treat Hepatitis C during the study.I have been diagnosed with HIV.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Preliminary Test of Combined LAI Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.