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Integrated Care (iCare) at Mount Sinai to Improve Substance Use Diagnosis and Treatment Practices in HIV Clinic Settings
NCT03092596 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 3,358 participants |
| Start Date | 2017-02-02 |
| Est. Completion | 2020-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03092596
The ClinicalTrials.gov registry entry for NCT03092596 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,358 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03092596 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03092596?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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