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Carolina Alcohol and Drug Resources (CADRE)

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ClinicalTrials.gov Identifier: NCT01791179
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
HIV Behavioral: Comprehensive substance abuse services Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carolina Alcohol and Drug Resources
Actual Study Start Date : February 2013
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Substance Abuse Treatment Group Behavioral: Comprehensive substance abuse services


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: February 13, 2013    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018