Intravenous Drug AbuseNCT01128920
Reducing Health Problems Associated With Injection Drug Use
A study testing Skin and Needle Hygiene Intervention in people with Intravenous Drug Abuse and HIV Infections, run by University of Northern Colorado at 1 site in United States.
Trial summary
The purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intravenous Drug Abuse, HIV Infections
- What is being tested?
- Skin and Needle Hygiene Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Project Safe, University of Colorado
Denver, Colorado, 80506
About this study
Official title: Reduction of Medical Complications 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.
Read the detailed description
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.
- Conditions
- Intravenous Drug Abuse, HIV Infections
- Being tested
- Skin and Needle Hygiene Intervention, No intervention - assessment-only condition
- Keywords
- bacterial infections, skin infections, HIV, Hepatitis C, risk reduction intervention
- Medical subject headings
- Substance Abuse, Intravenous, HIV Infections, Bacterial Infections, Cellulitis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin and Needle Hygiene InterventionBehavioural
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 conditionOther
No intervention is assigned in this condition
| Study group | Role | What they receive |
|---|---|---|
| Skin and Needle Hygiene Intervention | Experimental | Not described Receives: Behavioral: Skin and Needle Hygiene Intervention |
| Assessment-Only Condition | Experimental | Not described Receives: Other: No intervention - assessment-only condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
Measured: 1 month
Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
Measured: 6 months
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Measured: 1 month
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Measured: 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)
Measured: 1 month
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Measured: 1 month
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Measured: 6 months
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Butler Hospital
- Responsible party
- Principal investigator, Kristina Phillips, University of Northern Colorado
- Investigators
- Kristina T Phillips, Ph.D., Principal investigator, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128920
- Sponsor's protocol ID
- DA026773-01
- Status last verified
- Dec 2011
- First submitted
- 19 May 2010
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Medical Complications Associated With Injection Drug Use
- ClinicalTrials.gov ID
- NCT01128920
- Acronym / sponsor ID
- DA026773-01
- Conditions
- Intravenous Drug Abuse, HIV Infections
- Keywords
- bacterial infections, skin infections, HIV, Hepatitis C, risk reduction intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Butler Hospital
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin and Needle Hygiene Intervention | Experimental | Behavioral: Skin and Needle Hygiene Intervention |
| Assessment-Only Condition | Experimental | Other: No intervention - assessment-only condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin and Needle Hygiene InterventionIntervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices | Behavioural | Skin and Needle Hygiene Intervention |
| No intervention - assessment-only conditionNo intervention is assigned in this condition | Other | Assessment-Only Condition |
Primary outcome
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
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
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Time frame: 1 month
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Time frame: 6 months
4 secondary outcomes
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Time frame: 1 month
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Time frame: 1 month
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Time frame: 6 months
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
Related trials for Intravenous Drug Abuse
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RecruitingObservational study
A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs
Drug Abuse, Intravenous, Substance Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina T Phillips, Ph.D. principal investigator
University of Northern Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin and Needle Hygiene Intervention in people with Intravenous Drug Abuse and HIV Infections, run by University of Northern Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2012; AzTrials last refreshed its copy on 30 Oct 2026.