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Completed

NCT Number: NCT01128920

Reducing Health Problems Associated With Injection Drug Use

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

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Key information

Conditions

Intravenous Drug Abuse Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Cellulitis Chemically-Induced Disorders Communicable Diseases Connective Tissue Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Liver Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases, Infectious Skin and Connective Tissue Diseases Substance Abuse, Intravenous Substance-Related Disorders Suppuration Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Safe, University of Colorado

Denver, Colorado, 80506, United States

About this study

Injection drug use (IDU) is a major public health problem that is associated with a host of medical complications, including blood-borne viral disease (e.g., HIV, Hepatitis C) and bacterial infections (e.g., skin abscesses, endocarditis), that often result from high-risk drug injection practices. There are no current interventions designed to reduce bacterial infections among IDUs, despite high rates of infection.

The objective of this study is to develop and test the efficacy of a skin and needle hygiene intervention for IDUs to reduce practices associated with bacterial and viral infections. In the first phase of the study, focus group interviews were conducted to determine key areas of emphasis for an intervention with this population. An initial intervention was developed, pilot tested, and refined. The final 2-session intervention combines psychoeducation, skill-building, and motivational interviewing.

Following refinement of the intervention, a small randomized controlled trial (n = 60; 30 in each group) to examine the efficacy of the intervention compared to an assessment-only condition will be conducted. The goals of this two-year study are to: 1) reduce high-risk injection practices among active IDUs that lead to bacterial and viral infections, 2) improve skin and needle cleaning behavioral skills, and 3) increase skin cleaning prior to injection and reduce subcutaneous/intramuscular injection.

In addition to examining these goals over a six-month period, the acceptability and feasibility of the intervention will be examined.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

Skin and Needle Hygiene Intervention

Behavioral

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

No intervention - assessment-only condition

Other

No intervention is assigned in this condition

Primary outcomes

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

    Time frame: 1 month

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

    Time frame: 6 months

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

    Time frame: 1 month

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Northern Colorado

Other

Collaborators

  • Butler Hospital
  • University of Colorado, Denver

Registry information

Official study title

Reduction of Medical Complications Associated With Injection Drug Use

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 24, 2010
Registry last updated
Jan 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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