Combined Injectable Treatment for HIV and OUD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Immunodeficiency Virus, Opioid Use Disorder

Intervention / Treatment
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* Drug: Combined LAI Treatment: Cabenuva and Sublocade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preliminary Test of Combined LAI Treatment<br>The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) cabenuva for HIV and extended-release buprenorphine (XR-B) sublocade for OUD. | Drug: Combined LAI Treatment: Cabenuva and Sublocade<br>* 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<br>* Other names: extended-release buprenorphine (XR-B) sublocade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| 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 | 6 months | 
| Feasibility/Acceptability | 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 | 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, | 6 months | 
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use | National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) | 6 months | 
| Substance use | NIDA-modified ASSIST - tool to identify risky substance use | 6 months | 
| Substance use | urine drug screens from the individual's electronic medical record | 6 months | 
| HIV Risk Behavior | Texas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior | 6 months | 
| 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). | 6 months | 
| 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) | 6 months |