- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05991622
Combined Injectable Treatment for HIV and OUD (CHOICE)
August 7, 2023 updated by: Kirsten J Langdon, Rhode Island Hospital
Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kirsten K Langdon, Ph.D.
- Phone Number: 401-606-4198
- Email: kirsten.langdon@lifespan.org
Study Contact Backup
- Name: Kirsten J Langdon, Ph.D.
- Phone Number: 401-606-4198
- Email: kirsten.langdon@lifespan.org
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Kirsten Langdon
- Phone Number: 401-606-4198
- Email: kirsten.langdon@lifespan.org
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Preliminary Test of Combined LAI Treatment
The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rates
Time Frame: 6 months
|
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
|
6 months
|
Acceptability
Time Frame: 6 months
|
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
|
6 months
|
Feasibility/Acceptability
Time Frame: 6 months
|
Client Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services
|
6 months
|
Self-report of engagement in treatment
Time Frame: 6 months
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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,
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6 months
|
Feasibility/Acceptability
Time Frame: 6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substance use
Time Frame: 6 months
|
National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)
|
6 months
|
Substance use
Time Frame: 6 months
|
NIDA-modified ASSIST - tool to identify risky substance use
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6 months
|
Substance use
Time Frame: 6 months
|
urine drug screens from the individual's electronic medical record
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6 months
|
HIV Risk Behavior
Time Frame: 6 months
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Texas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior
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6 months
|
Treatment services
Time Frame: 6 months
|
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).
|
6 months
|
Overall Quality of life
Time Frame: 6 months
|
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)
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kirsten K Langdon, Ph.D., 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 Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
July 26, 2023
First Submitted That Met QC Criteria
August 7, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Narcotic-Related Disorders
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Rilpivirine
- Cabotegravir, rilpivirine drug combination
Other Study ID Numbers
- 1R34DA055498 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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