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Combined LAI Treatment for HIV/AIDS and Opioid Use Disorder (CHOICE Trial)

Q: Is recruitment currently open for participants in this experiment?

As indicated on clinicaltrials.gov, recruitment for this trial is still ongoing since its initial posting date of April 1st 2022 and latest update on August 7th 2023.

Q: How many individuals have signed up for this clinical research protocol?

Indeed, information sourced from clinicaltrials.gov confirms that this study was posted on April 1st 2022 and is actively recruiting subjects for participation. Currently, 40 patients are sought to be enrolled at a single medical site.

Q: What is the anticipated outcome of this research endeavor?

The principal aim of this experiment, which is scheduled to last for 6 months, is to determine the acceptability rating. Secondary objectives encompass gauging <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> risk behavior with <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Christian University's (TCU) HIV/<a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> Risk Assessment; assessing the uptake of case management, psychiatric care and peer recovery coaching using Treatment Services Review; and determining overall quality of life by administering Q-LES-Q-SF - a 16 item questionnaire that has been demonstrated to possess strong internal consistency and reliability in addition to convergent validity (80% sensitivity , 100% specificity).

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

CHOICE Trial 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.Check my eligibility

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.See study design

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.

CHOICE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Feasibility/Acceptability

Recruitment rates

+1 more

Secondary outcome measures

HIV Risk Behavior

Overall Quality of life

Substance use

+1 more

CHOICE 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,967 Total Patients Enrolled

Kirsten K Langdon, Ph.D.Principal InvestigatorRhode Island Hospital

Media Library

Preliminary Test of Combined LAI Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05991622 — Phase < 1

Opioid Use Disorder Research Study Groups: Preliminary Test of Combined LAI Treatment

Opioid Use Disorder Clinical Trial 2023: Preliminary Test of Combined LAI Treatment Highlights & Side Effects. Trial Name: NCT05991622 — Phase < 1

Preliminary Test of Combined LAI Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05991622 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently open for participants in this experiment?

"As indicated on clinicaltrials.gov, recruitment for this trial is still ongoing since its initial posting date of April 1st 2022 and latest update on August 7th 2023."

Answered by AI

How many individuals have signed up for this clinical research protocol?

"Indeed, information sourced from clinicaltrials.gov confirms that this study was posted on April 1st 2022 and is actively recruiting subjects for participation. Currently, 40 patients are sought to be enrolled at a single medical site."

Answered by AI

What is the anticipated outcome of this research endeavor?

"The principal aim of this experiment, which is scheduled to last for 6 months, is to determine the acceptability rating. Secondary objectives encompass gauging HIV risk behavior with Texas Christian University's (TCU) HIV/AIDS Risk Assessment; assessing the uptake of case management, psychiatric care and peer recovery coaching using Treatment Services Review; and determining overall quality of life by administering Q-LES-Q-SF - a 16 item questionnaire that has been demonstrated to possess strong internal consistency and reliability in addition to convergent validity (80% sensitivity , 100% specificity)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combined Injectable Treatment for HIV and OUD

Kirsten J Langdon 2022. "Combined Injectable Treatment for HIV and OUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05991622.

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