NCT01128920

Brief Summary

The purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 4, 2012

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

May 19, 2010

Last Update Submit

December 30, 2011

Conditions

Intravenous Drug AbuseHIV Infections

Keywords

bacterial infectionsskin infectionsHIVHepatitis Crisk reduction intervention

Outcome Measures

Primary Outcomes (4)

  • Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)

    1 month

  • Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)

    6 months

  • Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)

    1 month

  • Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)

    6 months

Secondary Outcomes (4)

  • Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)

    1 month

  • Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.

    1 month

  • Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)

    6 months

  • Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.

    6 months

Study Arms (2)

Skin and Needle Hygiene Intervention

EXPERIMENTAL
Behavioral: Skin and Needle Hygiene Intervention

Assessment-Only Condition

EXPERIMENTAL
Other: No intervention - assessment-only condition

Interventions

Skin and Needle Hygiene InterventionBEHAVIORAL

Intervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices

Skin and Needle Hygiene Intervention
No intervention - assessment-only conditionOTHER

No intervention is assigned in this condition

Assessment-Only Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • injection of heroin on at least three different days in the last week
  • injection of heroin for at least three months
  • visible track marks/puncture wounds from needles
  • positive urine screen for heroin

You may not qualify if:

  • currently exhibiting active psychotic symptoms
  • cannot complete study assessments or the intervention
  • cannot provide informed consent
  • unable to provide names and contact information for at least two verifiable locator persons who will know where to find client
  • plans to relocate from area or be jail over next six months
  • have been in a Project Safe study in the last year
  • report being pregnant or attempting to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Safe, University of Colorado

Denver, Colorado, 80506, United States

Location

MeSH Terms

Conditions

Substance Abuse, IntravenousHIV InfectionsBacterial InfectionsCellulitisHepatitis C

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBacterial Infections and MycosesSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Kristina T Phillips, Ph.D.

    University of Northern Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 24, 2010

Study Start

June 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 4, 2012

Record last verified: 2011-12

Locations

US(1)