Carolina Alcohol and Drug Resources (CADRE)
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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: Open Label Primary Purpose: Treatment |
| Official Title: | Carolina Alcohol and Drug Resources |
- 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).
- 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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01791179
| Contact: Susan S Reif, PhD | 704 258-7111 | susan.reif@duke.edu | |
| Contact: Sara LeGrand, PhD | 919 438-0448 | sara.legrand@duke.edu |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | Susan S. Reif, PhD | Duke University |
More Information
Additional Information:
| 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: | April 12, 2016 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on September 30, 2016