Substance AbuseNCT03092596
Integrated Care (iCare) at Mount Sinai to Improve Substance Use Diagnosis and Treatment Practices in HIV Clinic Settings
A study testing Patient-administered screening tool, Patient health navigator-administered screening tool and Patient health navigator-assisted linkage to treatment in people with Substance Abuse, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Patient-administered screening tool, Patient health navigator-administered screening tool and Patient health navigator-assisted linkage to treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,358 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Patient-administered screening tool, Patient health navigator-administered screening tool, Patient health navigator-assisted linkage to treatment
- Keywords
- HIV infection, drug abuse, substance use, alcohol abuse, screening, treatment, primary care, motivational interviewing
- Medical subject headings
- Substance-Related Disorders, HIV Infections, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-administered screening toolBehavioural
screener for drug and alcohol misuse - NIDA Quick Screen combined with AUDIT and DAST
Patient health navigator-administered screening toolBehavioural
patient health navigator-administered screener
Patient health navigator-assisted linkage to treatmentBehavioural
patient health navigator-assisted linkage to substance abuse treatment
| Study group | Role | What they receive |
|---|---|---|
| Patient-administered screening tool | Experimental | Patients will complete a screener for alcohol and drug misuse. Receives: Behavioral: Patient-administered screening tool |
| Patient health navigator-administered screening tool | Experimental | Patient health navigators will administer a screener for alcohol and drug misuse to patients. Receives: Behavioral: Patient health navigator-administered screening tool |
| Patient health navigator-assisted linkage to treatment | Experimental | Patient health navigators will be trained in motivational interviewing to engage patients about linkage to substance abuse treatment. Receives: Behavioral: Patient health navigator-assisted linkage to treatment |
| Treatment as usual | No intervention | Patients will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post intervention
Linkage to Substance Abuse Treatment
Proportion of patients at each HIV clinic who enroll in substance use treatment
Measured: 6 months post intervention
Secondary outcomes (3)
HIV Viral Load
HIV-related outcomes - HIV RNA
Measured: 6 months post intervention
CD4 Cell Count
HIV-related outcomes - CD4 cell count
Measured: 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
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start2 Feb 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ana Ventuneac, Icahn School of Medicine at Mount Sinai
- Investigators
- Ana Ventuneac, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092596
- Sponsor's protocol ID
- GCO 16-2634
- Other IDs
- R01DA041072
- Status last verified
- Jul 2020
- First submitted
- 22 Mar 2017
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structural Intervention to Improve Substance Abuse Diagnosis and Treatment Practices in HIV Clinic Settings
- ClinicalTrials.gov ID
- NCT03092596
- Acronym / sponsor ID
- GCO 16-2634
- Conditions
- Substance Abuse
- Keywords
- HIV infection, drug abuse, substance use, alcohol abuse, screening, treatment, primary care, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,358 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient-administered screening tool | Experimental | Behavioral: Patient-administered screening toolPatients will complete a screener for alcohol and drug misuse. |
| Patient health navigator-administered screening tool | Experimental | Behavioral: Patient health navigator-administered screening toolPatient health navigators will administer a screener for alcohol and drug misuse to patients. |
| Patient health navigator-assisted linkage to treatment | Experimental | Behavioral: Patient health navigator-assisted linkage to treatmentPatient health navigators will be trained in motivational interviewing to engage patients about linkage to substance abuse treatment. |
| Treatment as usual | No intervention | –Patients will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-administered screening toolscreener for drug and alcohol misuse - NIDA Quick Screen combined with AUDIT and DAST | Behavioural | Patient-administered screening tool |
| Patient health navigator-administered screening toolpatient health navigator-administered screener | Behavioural | Patient health navigator-administered screening tool |
| Patient health navigator-assisted linkage to treatmentpatient health navigator-assisted linkage to substance abuse treatment | Behavioural | Patient health navigator-assisted linkage to treatment |
Primary outcome
Substance Abuse Diagnosis
Time frame: 6 months post intervention
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
Time frame: 6 months post intervention
Proportion of patients at each HIV clinic who enroll in substance use treatment
3 secondary outcomes
HIV Viral Load
Time frame: 6 months post intervention
CD4 Cell Count
Time frame: 6 months post intervention
Comorbidities
Time frame: 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Ventuneac, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-administered screening tool, Patient health navigator-administered screening tool and Patient health navigator-assisted linkage to treatment in people with Substance Abuse, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance Abuse Diagnosis (time frame: 6 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.