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

A Structural Intervention to Improve Substance Abuse Diagnosis and Treatment Practices in HIV Clinic Settings

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.

Study Overview

• Status: Completed
• Conditions: Substance Abuse
• Intervention / Treatment: Behavioral: Patient-administered screening tool; Behavioral: Patient health navigator-administered screening tool; Behavioral: Patient health navigator-assisted linkage to treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 3358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-administered screening tool; Patients will complete a screener for alcohol and drug misuse.	Behavioral: Patient-administered screening tool; screener for drug and alcohol misuse - NIDA Quick Screen combined with AUDIT and DAST
Experimental: Patient health navigator-administered screening tool; Patient health navigators will administer a screener for alcohol and drug misuse to patients.	Behavioral: Patient health navigator-administered screening tool; patient health navigator-administered screener
Experimental: Patient health navigator-assisted linkage to treatment; Patient health navigators will be trained in motivational interviewing to engage patients about linkage to substance abuse treatment.	Behavioral: Patient health navigator-assisted linkage to treatment; patient health navigator-assisted linkage to substance abuse treatment
No Intervention: Treatment as usual; Patients will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months post intervention
Linkage to Substance Abuse Treatment	Proportion of patients at each HIV clinic who enroll in substance use treatment	6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Viral Load	HIV-related outcomes - HIV RNA	6 months post intervention
CD4 Cell Count	HIV-related outcomes - CD4 cell count	6 months post intervention
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	6 months post intervention

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ana Ventuneac, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: treatment; primary care; screening; motivational interviewing; HIV infection; substance use; drug abuse; alcohol abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: GCO 16-2634; R01DA041072 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No