Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- Number of Participants With HIV Viral Suppression, Per-protocol
研究概览
简要总结
The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.
详细描述
The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care clinics. The study is an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in HIV-infected participants with untreated opioid use disorder. Each participant will be engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and enrollment procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is at least 18 years old
- •Participant has provided written informed consent and HIPAA for medical record abstraction
- •Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder
- •Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder
- •Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)
- •Willing to establish ongoing HIV care at the site if not already receiving ongoing care
- •If female, willing to take at least one evidence-based measure to avoid becoming pregnant
排除标准
- •Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:
- •Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments
- •Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview
- •Suicidal or homicidal ideation requiring immediate attention
- •Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy
- •Participant has an international normalized ratio (INR) > 1.5 or platelet count <100k
- •Participant has a known allergy or sensitivity to naloxone, naltrexone, polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol diluent
- •Anticipate undergoing surgery during study participation
- •Have chronic pain requiring ongoing pain management with opioid analgesics
- •If female, currently (at time of consent) pregnant or breastfeeding or planning on conceiving in the coming months
- •Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)
- •Received methadone of buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening
- •Have taken an investigational drug in another study within 30 days of study consent
- •Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior to consent
- •Are currently in jail, prison or have a pending legal action which may prevent an individual from completing the study
研究组 & 干预措施
XR-NTX
Extended-release naltrexone
干预措施: Naltrexone Injectable Suspension (Drug)
TAU
Treatment as usual
干预措施: Treatment as usual (Other)
结局指标
主要结局
Number of Participants With HIV Viral Suppression, Per-protocol
时间窗: 12 weeks and 24 weeks
HIV-1 RNA \<200 copies/ml
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
时间窗: 12 weeks and 24 weeks
HIV-1 RNA \<200 copies/ml
Number of Participants With HIV Viral Suppression, Complete Case
时间窗: 12 weeks and 24 weeks
HIV-1 RNA \<200 copies/ml
次要结局
- Veterans Aging Cohort Study (VACS) Index(Baseline and 24 weeks)
- CD4 Count(Baseline and 24 weeks)
- Number of Participants With Multiple Sex Partners in Past 30 Days(Baseline and 24 weeks)
- Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks(24 weeks)
- Engagement in HIV Care: Quality of Life(Baseline and 24 weeks)
- Number of Participants Who Had Unprotected Sex in Past 30 Days(Baseline and 24 weeks)
- Engagement in HIV Care: Antiretroviral Therapy Prescribed(Baseline and 24 weeks)
- Engagement in HIV Care: 100% Antiretroviral Therapy Adherence(24 weeks)
- Number of Participants Who Test Positive for Opioids at 24 Weeks(24 weeks)
- Average Number of Self-Reported Days of Opioid Use in Last 30 Days(Between baseline and 24 weeks)
研究者
P. Todd Korthuis, MD
Professor of Medicine
Oregon Health and Science University