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
2 other identifiers
interventional
3,358
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2017
CompletedFirst Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 31, 2020
July 1, 2020
3.4 years
March 22, 2017
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
HIV Viral Load
6 months post intervention
CD4 Cell Count
6 months post intervention
Comorbidities
6 months post intervention
Study Arms (4)
Patient-administered screening tool
EXPERIMENTALPatients will complete a screener for alcohol and drug misuse.
Patient health navigator-administered screening tool
EXPERIMENTALPatient health navigators will administer a screener for alcohol and drug misuse to patients.
Patient health navigator-assisted linkage to treatment
EXPERIMENTALPatient health navigators will be trained in motivational interviewing to engage patients about linkage to substance abuse treatment.
Treatment as usual
NO INTERVENTIONPatients will receive standard care.
Interventions
screener for drug and alcohol misuse - NIDA Quick Screen combined with AUDIT and DAST
patient health navigator-administered screener
patient health navigator-assisted linkage to substance abuse treatment
Eligibility Criteria
You may qualify if:
- Registered as a patient at the Institute for Advanced Medicine at Mount Sinai
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Ventuneac, PhD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 22, 2017
First Posted
March 28, 2017
Study Start
February 2, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
July 31, 2020
Record last verified: 2020-07