## Protocol Section
### Identification Module
**NCT ID:** NCT01791179

**Acronym:** CADRE

**Brief Title:** Carolina Alcohol and Drug Resources

**Official Title:** Carolina Alcohol and Drug Resources

#### Organization Study ID Info
**ID:** Pro00042125
#### Organization
**Class:** OTHER
**Full Name:** Duke University
#### Secondary ID Infos
**ID:** 1H79TI024350-01
**Link:** https://reporter.nih.gov/quickSearch/1H79TI024350-01
**Type:** SAMHSA
### Status Module
#### Completion Date
**Date:** 2018-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2018-02-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-10-30

**Type:** ACTUAL

#### Start Date
**Date:** 2013-02

**Type:** ACTUAL

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2013-02-13
**Type:** ESTIMATED
**Study First Submit Date:** 2013-02-12
**Study First Submit QC Date:** 2013-02-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- HIV

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 306

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Comprehensive substance abuse services

**Label:** Substance Abuse Treatment Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Substance Abuse Treatment Group

**Name:** Comprehensive substance abuse services

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Change in substance use

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Change in medication adherence

**Time Frame:** 12 months

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Durham

**Country:** United States

**Facility:** Duke University

**State:** North Carolina

**Zip:** 27705

#### Overall Officials

**Official 1:**

**Affiliation:** Duke University

**Name:** Susan S. Reif, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://chpir.org

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
