Hepatitis CHep-NetNCT02474043
A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin
A study testing Hep-Net Intervention in people with Hepatitis C, run by University of Wisconsin, Madison.
Trial summary
The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral intervention for promoting screening for hepatitis C and reducing risky behavior for people who inject drugs (PWID). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hep-Net Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over
- English-speaking
- Reports injection of illicit drugs in the past month
Who cannot join
- Unable to provide informed consent due to cognitive impairment
- Unwilling to provide personal locator information and consent to be contacted for follow-up after 3 months.
- Currently known to be pregnant
About this study
The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral intervention for promoting screening for hepatitis C and reducing risky behavior for people who inject drugs (PWID).
Read the detailed description
People who inject drugs (PWID) are at high risk for hepatitis C virus (HCV) infection if they share contaminated injection equipment with others. Many are infected but are unaware of it, making it likely they will transmit the virus to others if they share contaminated injecting equipment. Problems related to hepatitis C can be avoided if people know their status by getting tested and referred to treatment.
In this study, the investigators will recruit eligible PWID in several cities in Wisconsin using a social networks strategy, in which clients who receive services at a syringe exchange program are asked to refer peers who also inject drugs to participate in the study. All participants will undergo a baseline computerized risk assessment that elicits information about hepatitis C status, previous testing, transmission risk behaviors, and overdose risk. Participants will then be randomly-assigned to receive either standard risk reduction counseling from a prevention specialist, or computerized tailored risk reduction messages that are specific to their reported risk behaviors, attitudes and beliefs. A follow-up assessment will be completed after 3 months to evaluate changes in behavioral risk and intention to undergo HCV screening. A database will be searched to determine which participants returned for HCV screening within 12 months of enrollment, and of those, which ones tested positive for HCV.
- Conditions
- Hepatitis C
- Being tested
- Hep-Net Intervention, Usual Care
- Keywords
- Injection drug use
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hep-Net InterventionBehavioural
The Hep-Net Intervention is a web-based questionnaire and tailored feedback system designed to increase readiness to change with respect to several behaviors. The behaviors include (1) reducing or quitting drug use; (2) using sterile equipment every time one injects drugs; (3) undergoing screening for hepatitis C; (4) receiving training to use naloxone to prevent death due to opioid overdose.
Usual CareBehavioural
Clients receive health education and risk reduction counseling from a trained prevention specialist.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Standard health education and prevention counseling by trained staff Receives: Behavioral: Usual Care |
| Hep-Net Intervention | Experimental | Computerized tailored behavioral intervention Receives: Behavioral: Hep-Net Intervention; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for hepatitis C infection
Participants will be followed for 12 months to determine whether they undergo repeated screening for hepatitis C
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- AIDS Resource Center of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Ryan Westergaard, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474043
- Sponsor's protocol ID
- 2013-1360
- Acronym
- Hep-Net
- Status last verified
- Jan 2019
- First submitted
- 15 Jun 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hochstatter KR, Hull SJ, Sethi AK, Burns ME, Mundt MP, Westergaard RP. Promoting Safe Injection Practices, Substance Use Reduction, Hepatitis C Testing, and Overdose Prevention Among Syringe Service Program Clients Using a Computer-Tailored Intervention: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Sep 29;22(9):e19703. doi: 10.2196/19703.
PubMed 32990630Westergaard RP, Hull SJ, Merkow A, Stephens LK, Hochstatter KR, Olson-Streed HK, Baker LM, Hess TM. Computerized Tailored Interventions to Enhance Prevention and Screening for Hepatitis C Virus Among People Who Inject Drugs: Protocol for a Randomized Pilot Study. JMIR Res Protoc. 2016 Jan 22;5(1):e15. doi: 10.2196/resprot.4830.
PubMed 26800903
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin
- ClinicalTrials.gov ID
- NCT02474043
- Acronym / sponsor ID
- Hep-Net / 2013-1360
- Conditions
- Hepatitis C
- Keywords
- Injection drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- AIDS Resource Center of Wisconsin
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jun 2015 (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 goal of this study is to evaluate the effectiveness of a brief, computerized behavioral intervention for promoting screening for hepatitis C and reducing risky behavior for people who inject drugs (PWID).
Detailed description
People who inject drugs (PWID) are at high risk for hepatitis C virus (HCV) infection if they share contaminated injection equipment with others. Many are infected but are unaware of it, making it likely they will transmit the virus to others if they share contaminated injecting equipment. Problems related to hepatitis C can be avoided if people know their status by getting tested and referred to treatment.
In this study, the investigators will recruit eligible PWID in several cities in Wisconsin using a social networks strategy, in which clients who receive services at a syringe exchange program are asked to refer peers who also inject drugs to participate in the study. All participants will undergo a baseline computerized risk assessment that elicits information about hepatitis C status, previous testing, transmission risk behaviors, and overdose risk. Participants will then be randomly-assigned to receive either standard risk reduction counseling from a prevention specialist, or computerized tailored risk reduction messages that are specific to their reported risk behaviors, attitudes and beliefs. A follow-up assessment will be completed after 3 months to evaluate changes in behavioral risk and intention to undergo HCV screening. A database will be searched to determine which participants returned for HCV screening within 12 months of enrollment, and of those, which ones tested positive for HCV.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual CareStandard health education and prevention counseling by trained staff |
| Hep-Net Intervention | Experimental | Behavioral: Hep-Net Intervention, Behavioral: Usual CareComputerized tailored behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over
- English-speaking
- Reports injection of illicit drugs in the past month
Key exclusion criteria (3 listed)
- Unable to provide informed consent due to cognitive impairment
- Unwilling to provide personal locator information and consent to be contacted for follow-up after 3 months.
- Currently known to be pregnant
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 |
|---|---|---|
| Hep-Net InterventionThe Hep-Net Intervention is a web-based questionnaire and tailored feedback system designed to increase readiness to change with respect to several behaviors. The behaviors include (1) reducing or quitting drug use; (2) using sterile equipment every time one injects drugs; (3) undergoing screening for hepatitis C; (4) receiving training to use naloxone to prevent death due to opioid overdose. | Behavioural | Hep-Net Intervention |
| Usual CareClients receive health education and risk reduction counseling from a trained prevention specialist. | Behavioural | Hep-Net Intervention, Usual care |
Primary outcome
Screening for hepatitis C infection
Time frame: 12 months
Participants will be followed for 12 months to determine whether they undergo repeated screening for hepatitis C
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 11 Jan 2019.
- Derived from this study: PubMed 32990630Hochstatter KR, Hull SJ, Sethi AK, Burns ME, Mundt MP, Westergaard RP. Promoting Safe Injection Practices, Substance Use Reduction, Hepatitis C Testing, and Overdose Prevention Among Syringe Service Program Clients Using a Computer-Tailored Intervention: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Sep 29;22(9):e19703. doi: 10.2196/19703.
- Derived from this study: PubMed 26800903Westergaard RP, Hull SJ, Merkow A, Stephens LK, Hochstatter KR, Olson-Streed HK, Baker LM, Hess TM. Computerized Tailored Interventions to Enhance Prevention and Screening for Hepatitis C Virus Among People Who Inject Drugs: Protocol for a Randomized Pilot Study. JMIR Res Protoc. 2016 Jan 22;5(1):e15. doi: 10.2196/resprot.4830.
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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.
Ryan Westergaard, MD, PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Hep-Net Intervention in people with Hepatitis C, run by University of Wisconsin, Madison.
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 3 inclusion and 3 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Screening for hepatitis C infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474043, which also lists 2 linked publications.
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 11 Jan 2019.