Combined Injectable Treatment for HIV and OUD

NCT ID: NCT05991622

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2026-02-28

Brief Summary

This is study seeks to evaluate perspectives of a 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. The current study seeks to conduct a single-arm open pilot trial of a clinical protocol and implementation approach for the combined HIV/OUD LAI treatment. Participants will include patients receiving treatment at TMH IC (n=30) and clinic staff (n=5-10). Participants will complete a baseline survey, receive the combined LAI treatment, 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.

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. Through formative qualitative evaluation, our team developed the clinical protocol and implementation procedures for the combine HIV and OUD care using long-acting injectable therapies. As such, the present study is recruiting TMH IC patients (n=30) and clinical staff (n=5-10) for a single-arm open pilot trial of the clinical protocol to determine the effectiveness of implementation strategies for the combined LAI treatment. The investigators expect that, as a result of this project, the protocol will demonstrate high degrees of feasibility, acceptability, and 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.

Conditions

Human Immunodeficiency Virus; Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Combined LAI Treatment: Cabenuva and Sublocade

Intervention Type: DRUG

A preliminary test of the combined LAI treatment will be conducted with a total of 30 individuals diagnosed with HIV and OUD that meet all other study inclusion criteria. Treatment will take place primarily at TMH IC (n=30). Participants deemed fit for the study (per recommendation by TMH IC staff and subsequent medical chart review) will 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 30 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

Interventions

Combined LAI Treatment: Cabenuva and Sublocade

A preliminary test of the combined LAI treatment will be conducted with a total of 30 individuals diagnosed with HIV and OUD that meet all other study inclusion criteria. Treatment will take place primarily at TMH IC (n=30). Participants deemed fit for the study (per recommendation by TMH IC staff and subsequent medical chart review) will 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 30 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

Intervention Type: DRUG

Other Intervention Names

rilpivirine (CAB/RPV) "cabenuva"; extended-release buprenorphine (XR-B) "sublocade"

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Josiah Rich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josiah D Rich, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34DA055498

Identifier Type: NIH

Identifier Source: org_study_id

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