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NCT03092596 · ClinicalTrials.gov registry record · NA

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

A NA study of Substance Abuse, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
3,358
Enrollment target
1
Study location

NCT03092596 is a NA study of Substance Abuse that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 3,358 participants, below the 5,202-participant average among 58 other Substance Abuse trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03092596, a NA study of Substance Abuse, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
3,358 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • BEHAVIORAL Patient-administered screening tool
  • BEHAVIORAL Patient health navigator-administered screening tool
  • BEHAVIORAL Patient health navigator-assisted linkage to treatment

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 3,358 participants
Start Date 2017-02-02
Est. Completion 2020-06-30
Phase NA

What the Registry Record Tells You About NCT03092596

The ClinicalTrials.gov registry entry for NCT03092596 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3,358 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,202-participant average among 58 other Substance Abuse trials with a reported enrollment target (35% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Substance Abuse appearing as the primary indexed condition, and to 3 interventions - of which Patient-administered screening tool is the first listed.

NCT03092596 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03092596 about?

NCT03092596 is a clinical study titled "Integrated Care (iCare) at Mount Sinai to Improve Substance Use 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 ...

What is the current status of trial NCT03092596?

This trial is currently completed. It is a NA study. The enrollment target is 3,358 participants. The study started on 2017-02-02. Estimated completion is 2020-06-30.

What conditions does trial NCT03092596 study?

This clinical trial studies the following conditions: Substance Abuse.

What interventions are being tested in trial NCT03092596?

The interventions under investigation include: Patient-administered screening tool (BEHAVIORAL), Patient health navigator-administered screening tool (BEHAVIORAL), Patient health navigator-assisted linkage to treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT03092596?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03092596 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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