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Integrated Care (iCare) at Mount Sinai to Improve Substance Use Diagnosis and Treatment Practices in HIV Clinic Settings

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-administered screening tool
Patient health navigator-administered screening tool
Patient health navigator-assisted linkage to treatment
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring HIV infection, drug abuse, substance use, alcohol abuse, screening, treatment, primary care, motivational interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Registered as a patient at the Institute for Advanced Medicine at Mount Sinai
  • 18 years of age or older
  • HIV-infected
  • Report alcohol use at hazardous levels or drug use in the past year
  • Ability to provide informed consent

Exclusion Criteria:

  • None

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Patient-administered screening tool

Patient health navigator-administered screening tool

Patient health navigator-assisted linkage to treatment

Treatment as usual

Arm Description

Patients will complete a screener for alcohol and drug misuse.

Patient health navigators will administer a screener for alcohol and drug misuse to patients.

Patient health navigators will be trained in motivational interviewing to engage patients about linkage to substance abuse treatment.

Patients will receive standard care.

Outcomes

Primary Outcome Measures

Substance Abuse Diagnosis
Proportion of patients with an alcohol or drug use diagnosis at each HIV clinic compared to proportion of patients who enroll in substance use treatment
Linkage to Substance Abuse Treatment
Proportion of patients at each HIV clinic who enroll in substance use treatment

Secondary Outcome Measures

HIV Viral Load
HIV-related outcomes - HIV RNA
CD4 Cell Count
HIV-related outcomes - CD4 cell count
Comorbidities
Number of other health indicators and comorbidities related to heart disease, diabetes mellitus, kidney disease, liver disease, osteoporosis, malignancies, cognitive disorders and chronic obstructive pulmonary disease

Full Information

First Posted
March 22, 2017
Last Updated
July 29, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03092596
Brief Title
Integrated Care (iCare) at Mount Sinai to Improve Substance Use Diagnosis and Treatment Practices in HIV Clinic Settings
Official Title
A Structural Intervention to Improve Substance Abuse Diagnosis and Treatment Practices in HIV Clinic Settings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Substance abuse and dependence is highly prevalent among people living with HIV and significantly exacerbates morbidity and mortality and accelerates HIV disease progression. Antiretroviral therapy (ART) has been the single most important treatment for slowing disease progression. ART adherence and HIV primary care are affected by a complex array of factors in the context of lives impacted by socioeconomic, psychological, and health challenges. Drugs and alcohol play a major role in non-adherence, engagement in care, and poor health outcomes among HIV-infected persons. While evidence is unequivocal that substance use treatment improves health outcomes, systems of care for the detection and treatment of substance abuse and dependence remain fragmented. Integrated approaches are key to the delivery of optimal care. Pragmatic or effectiveness trials can provide the best evidence about clinical practice to inform practitioners and policy makes about the most clinically and cost effective treatment to inform dissemination on a wider scale at the organizational and public health levels. The goal of this trial is to develop and test a comprehensive, integrated program to detect and reduce substance abuse and in turn, to improve ART adherence and HIV, substance use and associated health outcomes among HIV-infected patients. This trial will test the effectiveness of the intervention using a stepped wedge trial design to sequentially implement a screening tool and training of patient health navigators at HIV clinics in NYC.
Detailed Description
The goal of this research study is to develop an organizational-level intervention to enhance the adoption of screening for and treatment of substance use disorders among HIV-positive patients receiving care at the Institute for Advanced Medicine HIV primary care clinics. The primary research question is: What is the impact of a brief substance abuse screener and treatment referral process on substance use and HIV-related health outcomes among HIV-infected patients attending HIV care clinics? The study team will achieve four specific aims: Aim 1: Develop an intervention to integrate substance abuse treatment with HIV care in a consortium of HIV clinics in New York City. The principal investigator will conduct formative research and utilize the study team's findings about existing systems and approaches utilized at the Mount Sinai Health System to: 1) incorporate a brief screening tool to identify patients in need of further assessment or treatment for substance abuse; and 2) train patient health navigators (PHNs) in motivational interviewing (MI) to engage patients for substance abuse treatment. Aim 2: Test the effectiveness of the intervention using a stepped wedge trial design to sequentially implement a screening tool and training of PHNs at the IAM HIV clinics. The primary goal is to test the effectiveness of intervention components versus treatment as usual (TAU) in identifying HIV infected persons with a substance use disorder and in linking them to substance abuse treatment. Secondary goals include examining the intersection among problematic substance use, HIV medication adherence, and HIV-related and other comorbid conditions. Aim 3. Develop optimized technologies within the electronic health record (EHR) system used at the HIV clinics and integrate these with existing substance-use treatment mobile applications to retain patients in recovery and relapse prevention. This will specifically entail use of a MyChart mobile patient portal in an Office of the National Coordinator for Health Information Technology (ONC) certified EHRs (Epic, Epic Systems Corporation, Verona, WI). The Affordable Care Act (ACA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act place strong emphasis on the widespread adoption and implementation of EHR systems. Aim 4: Assess the cost-effectiveness of implementing this organizational-level intervention. In order to enhance the likelihood of widespread implementation, the study team will conduct analyses to assess the cost-effectiveness of implementing the intervention components versus TAU alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
HIV infection, drug abuse, substance use, alcohol abuse, screening, treatment, primary care, motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-administered screening tool
Arm Type
Experimental
Arm Description
Patients will complete a screener for alcohol and drug misuse.
Arm Title
Patient health navigator-administered screening tool
Arm Type
Experimental
Arm Description
Patient health navigators will administer a screener for alcohol and drug misuse to patients.
Arm Title
Patient health navigator-assisted linkage to treatment
Arm Type
Experimental
Arm Description
Patient health navigators will be trained in motivational interviewing to engage patients about linkage to substance abuse treatment.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Patients will receive standard care.
Intervention Type
Behavioral
Intervention Name(s)
Patient-administered screening tool
Intervention Description
screener for drug and alcohol misuse - NIDA Quick Screen combined with AUDIT and DAST
Intervention Type
Behavioral
Intervention Name(s)
Patient health navigator-administered screening tool
Intervention Description
patient health navigator-administered screener
Intervention Type
Behavioral
Intervention Name(s)
Patient health navigator-assisted linkage to treatment
Intervention Description
patient health navigator-assisted linkage to substance abuse treatment
Primary Outcome Measure Information:
Title
Substance Abuse Diagnosis
Description
Proportion of patients with an alcohol or drug use diagnosis at each HIV clinic compared to proportion of patients who enroll in substance use treatment
Time Frame
6 months post intervention
Title
Linkage to Substance Abuse Treatment
Description
Proportion of patients at each HIV clinic who enroll in substance use treatment
Time Frame
6 months post intervention
Secondary Outcome Measure Information:
Title
HIV Viral Load
Description
HIV-related outcomes - HIV RNA
Time Frame
6 months post intervention
Title
CD4 Cell Count
Description
HIV-related outcomes - CD4 cell count
Time Frame
6 months post intervention
Title
Comorbidities
Description
Number of other health indicators and comorbidities related to heart disease, diabetes mellitus, kidney disease, liver disease, osteoporosis, malignancies, cognitive disorders and chronic obstructive pulmonary disease
Time Frame
6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Registered as a patient at the Institute for Advanced Medicine at Mount Sinai 18 years of age or older HIV-infected Report alcohol use at hazardous levels or drug use in the past year Ability to provide informed consent Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Ventuneac, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Integrated Care (iCare) at Mount Sinai to Improve Substance Use Diagnosis and Treatment Practices in HIV Clinic Settings

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