Combined Injectable Treatment for HIV and OUD — CHOICE  

Human Immunodeficiency Virus Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Opioid Use Disorder
• Opioid-Related Disorders

• NCT number: NCT05991622
• Study type: Interventional
• Source: Rhode Island Hospital
• Contact: Kirsten K Langdon, Ph.D.
• Phone: 401-606-4198
• Email: kirsten.langdon@lifespan.org
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2022
• Completion date: October 2024