Clinical trial NCT05991622: Combined Injectable Treatment for HIV and OUD
Official title: Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Human Immunodeficiency Virus
Opioid Use Disorder
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment rates
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Feasibility/Acceptability
timeFrame: 6 months
measure: Self-report of engagement in treatment
timeFrame: 6 months
measure: Feasibility/Acceptability
timeFrame: 6 months
Secondary outcomes:
measure: Substance use
timeFrame: 6 months
measure: Substance use
timeFrame: 6 months
measure: Substance use
timeFrame: 6 months
measure: HIV Risk Behavior
timeFrame: 6 months
measure: Treatment services
timeFrame: 6 months
measure: Overall Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Kirsten K Langdon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: