Carolina Alcohol and Drug Resources (CADRE)

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01791179

First Posted: February 13, 2013

Last Update Posted: May 11, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Duke University

Purpose

Substance abuse is highly prevalent among individuals with HIV and associated with negative outcomes including poorer medication adherence and HIV risk behavior. The primary aim of this project is to address substance abuse among individuals with or at high-risk for HIV by enhancing and expanding the substance abuse services provided in the formerly Substance Abuse and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug Expansion Team (CADET) program, which offered comprehensive substance abuse care for individuals with HIV living primarily in the Durham NC area. Services will be enhanced by adding peer outreach and navigation services to improve treatment engagement and participation and expanded to replicate the enhanced CADET service model in Charlotte NC.

The target population for this project is minority individuals, primarily African-Americans, with HIV or at high-risk for HIV with a particular focus on minority men who have sex with men (MSM)s. The program will provide up to 18 months of comprehensive services for approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance treatment engagement 2) individual and group substance abuse treatment using evidence-based models 3) ongoing recovery groups for individuals who have completed the intensive substance abuse treatment phase and 4) linkage to needed services such as case management, psychiatric care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and treatment services for minority MSM of unknown HIV status to increase access and utilization of substance use services and identify HIV and Hepatitis status.

The study evaluation will involve analysis of participant survey data gathered at baseline, 6, 12, 18 months of study participation to determine the effect of the comprehensive substance abuse care services on outcomes for individuals with HIV including substance use, mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV services. The study will also determine the effect of the comprehensive substance use program on substance abuse, mental health, and risk behavior outcomes for minority MSM who are not HIV-positive.

Condition	Intervention
HIV	Behavioral: Comprehensive substance abuse services


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Carolina Alcohol and Drug Resources

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Change in substance use [ Time Frame: 12 months ]
Substance use information will be collected at baseline, 6, and 12 months through surveys using standardized substance use measures including the Addiction Severity Index (ASI).

Secondary Outcome Measures:

Change in medication adherence [ Time Frame: 12 months ]
HIV medication adherence data will be collected at baseline, 6, and 12 months through surveys using standardized adherence measures in the visual analog scale and CASE adherence measure.


Study Start Date:	February 2013
Estimated Study Completion Date:	October 30, 2018
Estimated Primary Completion Date:	October 30, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Substance Abuse Treatment Group	Behavioral: Comprehensive substance abuse services

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-positive or minority MSM
substance abuse
18 or over

Exclusion Criteria:

Under 18
cognitive impairment that would preclude participation in substance abuse treatment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791179

Locations


United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Investigators


Principal Investigator:	Susan S. Reif, PhD	Duke University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01791179 History of Changes
Other Study ID Numbers:	Pro00042125 1H79TI024350-01 ( U.S. SAMHSA Grant/Contract )
First Submitted:	February 12, 2013
First Posted:	February 13, 2013
Last Update Posted:	May 11, 2017
Last Verified:	April 2017

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