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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Delaware
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Delaware
ClinicalTrials.gov Identifier:
NCT02116179
First received: April 14, 2014
Last updated: December 1, 2015
Last verified: December 2015
  Purpose

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. 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. 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. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.

Condition Intervention
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome
Hepatitis C
Behavioral: DVD Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: DVD-based HIV/HCV Intervention for Drug-Involved Latino Criminal Justice Clients

Resource links provided by NLM:


Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • Sexual risk behaviors [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Drug Use Behaviors [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: July 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DVD Intervention
DVD Intervention presented at one 90 minute group session
Behavioral: DVD Intervention
Participants will be randomly assigned, with a baseline and 3 month follow up assessments
No Intervention: Wait list Control Group
Group will get no intervention until after 90 day follow up

Detailed Description:

The specific aims for Stage1b are: (1) to pilot test and evaluate the effectiveness of the DVD-based HIV intervention by recruiting 210 Latino offenders mandated to substance abuse treatment; and (2) to evaluate both participant and interventionist acceptability of this novel DVD intervention. Participants will be recruited from a local community agency that provides outpatient substance abuse treatment services for court-mandated individuals. Eligible participants will be self-identified Latino/Hispanic, between the ages of 18 and 49, heterosexual, and all participants will be involved with the criminal justice system. Participants will be randomized into either an intervention or a wait-list control condition. The intervention consists of one DVD-based group session facilitated by an interventionist. Sexual risk, drug use, mental health, and background information will be assessed at baseline, and again at 3 months after the intervention session. At the end of the intervention session, each participant will complete an acceptability questionnaire, and the interventionist will complete a checklist to assess treatment fidelity. It is hypothesized that both sexual risk and drug use behaviors will decrease between baseline and follow-up for the intervention group compared to the control group. The project is innovative because it will develop a DVD-based, culturally-appropriate and language specific, HIV/Hepatitis C virus prevention intervention for Latino offenders. The proposed research is significant, because it is expected to produce a brief HIV/Hepatitis C virus intervention that can be implemented within the criminal justice system and targets a high risk group.

It is hypothesized that participants in the intervention condition will report significant reductions in sexual risk behaviors (e.g., unprotected sexual contact) and drug risk behaviors (e.g. sharing injection equipment, drug use while having sex) from baseline to 3 - month follow-up when compared to control group. The main analysis here is to compare the proportion (or mean) of primary outcomes for those measured at 3-month (post-intervention) to those measured at baseline (pre-intervention) between the intervention and control group. The null is that there will be no differences, and alternative hypotheses would be that the intervention group will report more of a reduction in risk behaviors than control group. These hypotheses can be tested by either repeated-measures ANCOVA or regression with the robust cluster estimator obtained after controlling for intervention condition.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • be HIV positive
  • be cognitively impaired
  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: NCT02116179

Contacts
Contact: Gladys E Ibanez, PhD 305-348-4920 gibanez@fiu.edu
Contact: Steven S Martin, MA 302-831-1564 martin@udel.edu

Locations
United States, Florida
University of Delaware Center for Drug and Alcohol Studies Recruiting
Coral Gables, Florida, United States, 33143
Contact: Gladys E Ibanez, PhD    305-348-4920    gibanez@fiu.edu   
Contact: Steven S Martin, MA    302-831-1564    martin@udel.edu   
Principal Investigator: Gladys E Ibanez, PhD         
Principal Investigator: Steven S Martin, MA         
Sponsors and Collaborators
University of Delaware
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Gladys E Ibanez, PhD Florida International University
  More Information

Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT02116179     History of Changes
Other Study ID Numbers: 5R34DA031063 
Study First Received: April 14, 2014
Last Updated: December 1, 2015
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Delaware:
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome
Hepatitis C
Hispanic
Criminal Justice

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2016