search
Back to results

Combined Injectable Treatment for HIV and OUD (CHOICE)

Primary Purpose

Human Immunodeficiency Virus, Opioid Use Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Combined LAI Treatment: Cabenuva and Sublocade
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Participants recruited through RIDOC will have an additional requirement of anticipated release from jail/prison within 6 months. 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

Sites / Locations

  • Rhode Island HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preliminary Test of Combined LAI Treatment

Arm Description

The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.

Outcomes

Primary Outcome Measures

Recruitment rates
percent of patients interested in the treatment, patient eligibility rate, consent rate, rate of recruitment, percent of participants who initiate injectables, follow-up completion rate (through 6 months), and reasons for refusal
Acceptability
study dropout rate (those who were lost to follow-up) and rate of discontinuation of injectables (those who decided to transition back to oral/sublingual regimen) as indices of
Feasibility/Acceptability
Client Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services
Self-report of engagement in treatment
Treatment Effectiveness Assessment : elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains -- substance use, health, lifestyle, community,
Feasibility/Acceptability
Qualitative interviews to explore the acceptability and feasibility of the intervention format (e.g. processes and procedures, access to support services, tolerability of medication) and how the intervention could be strengthened, identifying areas needing refinement or improvement for future iterations.

Secondary Outcome Measures

Substance use
National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)
Substance use
NIDA-modified ASSIST - tool to identify risky substance use
Substance use
urine drug screens from the individual's electronic medical record
HIV Risk Behavior
Texas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior
Treatment services
Treatment Services Review will be used to assess receipt of case management, psychiatric, peer recovery coaching, and other treatment services, including utilization of other medications for OUD (e.g., if a participant has transitioned to Methadone).
Overall Quality of life
Q-LES-Q-SF, a psychometrically sound shorter version of the original Q-LES-Q. It consists of a self-reported 16-item questionnaire that has shown internal consistency, rest-retest reliability, and convergent and criterion validity (80% sensitivity, 100% specificity)

Full Information

First Posted
July 26, 2023
Last Updated
August 7, 2023
Sponsor
Rhode Island Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05991622
Brief Title
Combined Injectable Treatment for HIV and OUD
Acronym
CHOICE
Official Title
Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a one-year study that seeks to evaluate perspectives of 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. Therefore, this study will conduct qualitative (1:1) interviews with 32-45 key stakeholders to assess interest, knowledge, attitudes, barriers, and facilitators to integrated injectable treatment. Our team will utilize qualitative findings to inform clinical strategies to promote uptake and maintenance of long-acting injectable medications for HIV and OUD.
Detailed Description
Treatment services for HIV and OUD have historically been delivered across multiple settings leading to fragmented and uncoordinated care. Models of behavior change suggest that addressing multiple health conditions simultaneously through integrated, evidence-based, interventions has the potential to overcome traditional barriers to optimize engagement and improve clinical outcomes. Consistent with this perspective, numerous studies have documented that receipt of opioid agonist treatment, in the context of HIV care, is associated with ART adherence and decreased HIV viral loads. Recent pharmacological advancements have led to the development of novel long-acting, injectable, medications for HIV [cabotegravir co-administered with rilpivirine (CAB/RPV)] and OUD (extended-release buprenorphine). These therapies have the potential to dramatically improve adherence, lead to better control of both diseases, and reduce mortality rates for this vulnerable population. However, currently, little is known about 1) the perceived acceptability/feasibility of combining HIV and OUD treatment into a single point of care; and 2) how best to deliver integrated, monthly injectable, treatment for HIV and OUD to facilitate future implementation. The long-term goal of this line of research is to disseminate an efficacious, integrated, injectable treatment program for HIV and OUD. The objective of this application is to develop, through formative evaluation, clinical strategies that promote best practices for combined HIV and OUD care using long-acting injectable therapies. In-depth, individual, interviews will be conducted with patients with a history of HIV and OUD as well as clinical content experts to assess interest, knowledge, attitudes, barriers, and facilitators to uptake of integrated injectable treatment. The investigators expect that, as a result of this project, the investigators will have developed a clinical protocol, with high degrees of feasibility and acceptability, to promote uptake of long-acting injectable medications for HIV and OUD. This work will serve as the foundation for a future NIH Hybrid Type 1 Effectiveness-Implementation study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Opioid Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preliminary Test of Combined LAI Treatment
Arm Type
Experimental
Arm Description
The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.
Intervention Type
Drug
Intervention Name(s)
Combined LAI Treatment: Cabenuva and Sublocade
Other Intervention Name(s)
rilpivirine (CAB/RPV) "cabenuva", extended-release buprenorphine (XR-B) "sublocade"
Intervention Description
A preliminary test of the combined LAI treatment will be conducted with a total of 40 individuals diagnosed with HIV and OUD that meet all other study inclusion criteria. Treatment will take place primarily at TMH IC (n=30), however, about one-quarter of participants will undergo the pilot test at the RIDOC (n=10). Participants will complete a baseline interview, receive the combined LAI treatment (described below), 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. We will also elicit feedback from clinic staff and other key stakeholders regarding the delivery of the clinical protocol and other implementation factors
Primary Outcome Measure Information:
Title
Recruitment rates
Description
percent of patients interested in the treatment, patient eligibility rate, consent rate, rate of recruitment, percent of participants who initiate injectables, follow-up completion rate (through 6 months), and reasons for refusal
Time Frame
6 months
Title
Acceptability
Description
study dropout rate (those who were lost to follow-up) and rate of discontinuation of injectables (those who decided to transition back to oral/sublingual regimen) as indices of
Time Frame
6 months
Title
Feasibility/Acceptability
Description
Client Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services
Time Frame
6 months
Title
Self-report of engagement in treatment
Description
Treatment Effectiveness Assessment : elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains -- substance use, health, lifestyle, community,
Time Frame
6 months
Title
Feasibility/Acceptability
Description
Qualitative interviews to explore the acceptability and feasibility of the intervention format (e.g. processes and procedures, access to support services, tolerability of medication) and how the intervention could be strengthened, identifying areas needing refinement or improvement for future iterations.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Substance use
Description
National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)
Time Frame
6 months
Title
Substance use
Description
NIDA-modified ASSIST - tool to identify risky substance use
Time Frame
6 months
Title
Substance use
Description
urine drug screens from the individual's electronic medical record
Time Frame
6 months
Title
HIV Risk Behavior
Description
Texas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior
Time Frame
6 months
Title
Treatment services
Description
Treatment Services Review will be used to assess receipt of case management, psychiatric, peer recovery coaching, and other treatment services, including utilization of other medications for OUD (e.g., if a participant has transitioned to Methadone).
Time Frame
6 months
Title
Overall Quality of life
Description
Q-LES-Q-SF, a psychometrically sound shorter version of the original Q-LES-Q. It consists of a self-reported 16-item questionnaire that has shown internal consistency, rest-retest reliability, and convergent and criterion validity (80% sensitivity, 100% specificity)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Participants recruited through RIDOC will have an additional requirement of anticipated release from jail/prison within 6 months. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten K Langdon, Ph.D.
Phone
401-606-4198
Email
kirsten.langdon@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten J Langdon, Ph.D.
Phone
401-606-4198
Email
kirsten.langdon@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten K Langdon, Ph.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Langdon
Phone
401-606-4198
Email
kirsten.langdon@lifespan.org

12. IPD Sharing Statement

Learn more about this trial

Combined Injectable Treatment for HIV and OUD

We'll reach out to this number within 24 hrs