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

Primary Purpose

Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DVD Intervention
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Hepatitis C, Hispanic, Criminal Justice

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Delaware Center for Drug and Alcohol Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DVD Intervention

Wait list Control Group

Arm Description

DVD Intervention presented at one 90 minute group session

Group will get no intervention until after 90 day follow up

Outcomes

Primary Outcome Measures

Sexual risk behaviors

Secondary Outcome Measures

Drug Use Behaviors

Full Information

First Posted
April 14, 2014
Last Updated
October 19, 2016
Sponsor
University of Delaware
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02116179
Brief Title
DVD-based HIV/HCV Prevention Intervention for Drug-Involved Latino Criminal Justice Clients
Official Title
DVD-based HIV/HCV Intervention for Drug-Involved Latino Criminal Justice Clients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Hepatitis C
Keywords
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Hepatitis C, Hispanic, Criminal Justice

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVD Intervention
Arm Type
Experimental
Arm Description
DVD Intervention presented at one 90 minute group session
Arm Title
Wait list Control Group
Arm Type
No Intervention
Arm Description
Group will get no intervention until after 90 day follow up
Intervention Type
Behavioral
Intervention Name(s)
DVD Intervention
Intervention Description
Participants will be randomly assigned, with a baseline and 3 month follow up assessments
Primary Outcome Measure Information:
Title
Sexual risk behaviors
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Drug Use Behaviors
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gladys E Ibanez, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware Center for Drug and Alcohol Studies
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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