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临床试验/NCT05991622
NCT05991622撤回2 期

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

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
入组人数
40
试验地点
1
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Preliminary Test of Combined LAI Treatment

Experimental

The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.

干预措施: Combined LAI Treatment: Cabenuva and Sublocade (Drug)

结局指标

主要结局

Acceptability

时间窗: 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

Self-report of engagement in treatment

时间窗: 6 months

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,

Recruitment rates

时间窗: 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

Feasibility/Acceptability

时间窗: 6 months

Client Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services

次要结局

  • Treatment services(6 months)
  • Overall Quality of life(6 months)
  • HIV Risk Behavior(6 months)
  • Substance use(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josiah Rich

Principal Investigator

Rhode Island Hospital

研究点 (1)

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