INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons Who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV and Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 447
- 试验地点
- 5
- 主要终点
- Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site
研究概览
简要总结
The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention - to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP).
详细描述
The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention - to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP). The intervention arm receiving health services in the mobile unit will be supported by peer navigation. An active control arm will receive peer navigation to health services available at community-based agencies. Impact (cost-effectiveness, mathematical modeling) and implementation factors (mixed methods to identify barriers and facilitators of the interventions) will contextualize findings from the efficacy analysis. The impact of the COVID-19 epidemic in the study population will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •At least 18 years of age
- •Urine test positive for recent opioid use and with evidence of recent injection drug use ("track marks")
- •Diagnosed with OUD per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
- •Able and willing to give informed consent
- •Willing to start MOUD treatment
- •Able to successfully complete an Assessment of Understanding
- •Self-reported sharing injection equipment and/or condomless sex in the last three months with partners of HIV-positive or unknown status
- •Able to provide adequate locator information
- •Confirmed HIV status, as defined in the HPTN 094 Study Specific Procedures Manual
排除标准
- •Urine testing that is not negative for methadone within 30 days prior to Enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.
- •Received MOUD in the 30 days prior to enrollment by self-report
- •Co-enrollment in any other interventional study unless approved by the Clinical Management Committee (CMC)
研究组 & 干预措施
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Harm reduction services (Behavioral)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Primary care (Other)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Peer navigation (Behavioral)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: COVID-19 testing and referral for further evaluation, care and/or treatment (Diagnostic Test)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: HIV testing (Diagnostic Test)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: Sexually transmitted infection (STI) testing and treatment (Diagnostic Test)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) (Drug)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: HIV testing (Diagnostic Test)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: HIV treatment for participants living with HIV not already in care (Drug)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: PrEP for participants without HIV (Drug)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV) (Diagnostic Test)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Testing and referral for treatment for hepatitis C virus (HCV) (Diagnostic Test)
Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
干预措施: Sexually transmitted infection (STI) testing and treatment (Diagnostic Test)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV) (Diagnostic Test)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: Testing and referral for treatment for hepatitis C virus (HCV) (Diagnostic Test)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: Harm reduction services (Behavioral)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: Peer navigation (Behavioral)
Peer navigation to connect them to health services available at community-based agencies
Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
干预措施: COVID-19 testing and referral for further evaluation, care and/or treatment (Diagnostic Test)
结局指标
主要结局
Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site
时间窗: 26 weeks
Documented current use of MOUD. At the Week 26 visit: 1. Alive 2. Retained 3. Biological evidence of MOUD (any detectable Methadone or Buprenorphine) 4. A MOUD prescription current at the week 26 visit or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)
Number and Percentage of Participants With Documented Current Use of PrEP at Week 26 by Site
时间窗: 26 weeks
Evaluate whether the intervention increases use of PrEP among people without HIV, as measured at 26 weeks, by assessing the following endpoint: • Among participants who were without HIV at enrollment: alive, retained, without HIV, with detectable PrEP drugs (Truvada or Descovy) in dried blood spot (DBS) samples, or (Cabotegravir) in plasma samples, at the Week 26 visit
次要结局
- Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site(52 weeks)
- Number and Percentage of Participants With Viral Suppression Among People Enrolled Living With HIV, at 26 and 52 Weeks by Site(26 weeks and 52 weeks)
- Number and Percentage of Participants With Documented Use of PrEP Among Participants Living Without HIV at Enrollment by Site at Week 26 and 52(26 weeks and 52 weeks)
- Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks(26 weeks and 52 weeks)
- Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and Week 52(26 weeks and 52 weeks)
- Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks(26 weeks and 52 weeks)
- Incidence Rate for Self-reported Non-fatal Overdose Events by 26 and 52 Weeks(Enrollment, 26 weeks and 52 weeks)
- Number and Percentage of Participants With Undetectable HCV RNA Among Those With Chronic HCV Infection at Enrollment(26 weeks and 52 weeks)
- Incidence Rate and CI for HCV Incidence(52 weeks)
- Number and Percentage of Participants in the Intervention Arm for Documented MOUD Use at Week 26 and 52(26 weeks and 52 weeks)
- Number and Percentage of Participants in the Control Arm With Documented MOUD Use at Week 26 and 52(26 weeks and 52 weeks)
- Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks(26 weeks and 52 weeks)
- Number and Percentage of Participants in the Control Arm for Viral Suppression at 26 and 52 Weeks(26 weeks and 52 weeks)
- Number and Percentage of Participants in the Intervention Arm With Documented Use of PrEP at 26 and 52 Weeks(26 weeks and 52 weeks)
- Number and Percentage of Participants in the Control Arm With Documented Use of PrEP at 26 and 52 Weeks(26 weeks and 52 weeks)
- Assess the Prevalence of SARS-CoV-2 Seropositivity at Baseline, 26 and 52 Weeks(Baseline, 26 weeks, and 52 weeks)