CADRE: Carolina Alcohol and Drug Resources

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01791179
Collaborator
(none)
306
1
1
60
5.1

Study Details

Study Description

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
  • Behavioral: Comprehensive substance abuse services
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
306 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Carolina Alcohol and Drug Resources
Actual Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Oct 30, 2017
Actual Study Completion Date :
Jan 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Substance Abuse Treatment Group

Behavioral: Comprehensive substance abuse services

Outcome Measures

Primary Outcome Measures

  1. Change in substance use [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Susan S. Reif, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT01791179
Other Study ID Numbers:
  • Pro00042125
  • 1H79TI024350-01
First Posted:
Feb 13, 2013
Last Update Posted:
Feb 28, 2018
Last Verified:
Feb 1, 2018

Study Results

No Results Posted as of Feb 28, 2018