DVD-based HIV/HCV Prevention Intervention for Drug-Involved Latino Criminal Justice Clients

NCT02116179 | Completed DMC

• 1 other identifier: 5R34DA031063
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention. They study hypothesis are the following:

1. 1.participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group;
2. 2.participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group;
3. 3.participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.

Conditions

Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Hepatitis C

Keywords

Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Hepatitis C; Hispanic; Criminal Justice

Outcome Measures

Primary Outcomes (1)

• Sexual risk behaviors

  90 days

Secondary Outcomes (1)

• Drug Use Behaviors

  90 days

Study Arms (2)

DVD Intervention

EXPERIMENTAL

DVD Intervention presented at one 90 minute group session

Behavioral: DVD Intervention

Wait list Control Group

NO INTERVENTION

Group will get no intervention until after 90 day follow up

Interventions

DVD Intervention BEHAVIORAL

Participants will be randomly assigned, with a baseline and 3 month follow up assessments

DVD Intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• must be between 18 - 49 years of age
• self-identify as Hispanic or Latino
• be involved in the criminal justice system
• report a history of drug use
• be in an outpatient substance abuse program
• self-identify as heterosexual

You may not qualify if:

• be HIV positive
• be cognitively impaired

Sponsors & Collaborators

• University of Delaware: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Delaware Center for Drug and Alcohol Studies

Coral Gables, Florida, 33143, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Gladys E Ibanez, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)