HIV and HCV Intervention In Drug Treatment Settings - 1 | NCT00102349

Studies
HIV and HCV Intervention In Drug Treatment Settings - 1

NCT00102349

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

706

Phase

Phase 3

Conditions

Behavior Therapy

Interventions

Behavior Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Jan 27, 2005

First Submission Date that Met QC Criteria

Jan 27, 2005

First Posted Date

Jan 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Name	Class
Oregon Health and Science University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test two strategies to reduce the risk of contracting Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in patients undergoing drug detoxification.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

706

Name	Type	Description	Arm Group Labels	Other Names
Behavior Therapy	Behavioral

Measure	Description	Time Frame
HIV/HCV injection risk behaviors

Eligibility Module

Eligibility Criteria

Volunteers will be IV drug users already enrolled in drug detoxification treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Booth, Ph.D.	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver Health & Hosp Authority		Denver	Colorado	80204 4507	United States
Island Grove RTC

Intervention Browse Module

MeSH Terms

ID	Term
D001521	Behavior Therapy

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided