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Carolina Alcohol and Drug Resources (CADRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01791179
First received: February 12, 2013
Last updated: March 27, 2014
Last verified: March 2014
  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
Primary Purpose: Treatment
Official Title: Carolina Alcohol and Drug Resources

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in substance use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 690
Study Start Date: February 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Substance Abuse Treatment Group Behavioral: Comprehensive substance abuse services

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791179

Contacts
Contact: Susan S Reif, PhD 704 258-7111 susan.reif@duke.edu
Contact: Sara LeGrand, PhD 919 438-0448 sara.legrand@duke.edu

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Susan S. Reif, PhD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01791179     History of Changes
Other Study ID Numbers: Pro00042125, 1H79TI024350-01
Study First Received: February 12, 2013
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2014