Having Ever Injected DrugsSHPNCT02234167
The Swedish Prison Program is an Intervention Prevention Program Targeting Injecting Drug Users Risk Behaviours and Infectious Diseases
A study testing Risk behaviour and infectious diseases in people with Having Ever Injected Drugs, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU) with primary and secondary health interventions with regards to injecting and sexual risk behaviours and infectious diseases such as… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Having Ever Injected Drugs
- What is being tested?
- Risk behaviour and infectious diseases
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Apr 2002to 31 Dec 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Defined as an injecting drug user, in the prison and probation service and agree to anonymously participate
Who cannot join
- Being defined as a non-drug user, non-injecting drug user
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Svenska Häktesprogrammet, Prevention, Risk Behaviour and Infectious Diseases Among IDU.
The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU) with primary and secondary health interventions with regards to injecting and sexual risk behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted infections (STI).
The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk behaviour and disease outcome among IDUs over time.
Read the detailed description
Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.
- Conditions
- Having Ever Injected Drugs
- Being tested
- Risk behaviour and infectious diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk behaviour and infectious diseasesBehavioural
Also called biological and behavioural
through counselling, testing vaccination
| Study group | Role | What they receive |
|---|---|---|
| Risk behaviour and infectious diseases | Other | .(among IDU) Receives: Behavioral: Risk behaviour and infectious diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with injection risk behaviour
Have you received already used injection equipment from someone last 12 months Have you lent (away) already used injection equipment to someone last 12 months Have you shared solution and/or filter with someone last 12 months Number of people shared needles with last month Number of injections last month Number of Hepatitis C positive Number of HIV positive Number of Hepatitis B positive Number of respondenst positive for sexually transmitted infections
Measured: 2002-2012
Secondary outcomes (1)
Number of participants with infectious diseases
HIV, HCV, HBV and STI
Measured: 2002-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startApr 2002
- Primary completionDec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Having Ever Injected DrugsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Sweden, Swedish Prison and Probation Service, Linkoeping University
- Responsible party
- Principal investigator, Niklas Karlsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234167
- Sponsor's protocol ID
- Swedish Prison Program
- Acronym
- SHP
- Status last verified
- Sep 2020
- First submitted
- 4 Apr 2014
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karlsson N, Santacatterina M, Kall K, Hagerstrand M, Wallin S, Berglund T, Ekstrom AM. Risk behaviour determinants among people who inject drugs in Stockholm, Sweden over a 10-year period, from 2002 to 2012. Harm Reduct J. 2017 Aug 16;14(1):57. doi: 10.1186/s12954-017-0184-8.
PubMed 28814336
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Svenska Häktesprogrammet, Prevention, Risk Behaviour and Infectious Diseases Among IDU.
- ClinicalTrials.gov ID
- NCT02234167
- Acronym / sponsor ID
- SHP / Swedish Prison Program
- Conditions
- Having Ever Injected Drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Public Health Agency of Sweden, Swedish Prison and Probation Service, Linkoeping University
- Study start
- Apr 2002
- Primary completion
- Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 9 Sep 2014 (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 the Swedish Prison Program which started back in 1987 and up until 2009 was called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU) with primary and secondary health interventions with regards to injecting and sexual risk behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted infections (STI).
The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk behaviour and disease outcome among IDUs over time.
Detailed description
Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk behaviour and infectious diseases | Other | Behavioral: Risk behaviour and infectious diseases.(among IDU) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Defined as an injecting drug user, in the prison and probation service and agree to anonymously participate
Key exclusion criteria (1 listed)
- Being defined as a non-drug user, non-injecting drug user
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 |
|---|---|---|
| Risk behaviour and infectious diseasesAlso: biological and behaviouralthrough counselling, testing vaccination | Behavioural | Risk behaviour and infectious diseases |
Primary outcome
Number of participants with injection risk behaviour
Time frame: 2002-2012
Have you received already used injection equipment from someone last 12 months Have you lent (away) already used injection equipment to someone last 12 months Have you shared solution and/or filter with someone last 12 months Number of people shared needles with last month Number of injections last month Number of Hepatitis C positive Number of HIV positive Number of Hepatitis B positive Number of respondenst positive for sexually transmitted infections
1 secondary outcome
Number of participants with infectious diseases
Time frame: 2002-2012
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 17 Sep 2020.
- Derived from this study: PubMed 28814336Karlsson N, Santacatterina M, Kall K, Hagerstrand M, Wallin S, Berglund T, Ekstrom AM. Risk behaviour determinants among people who inject drugs in Stockholm, Sweden over a 10-year period, from 2002 to 2012. Harm Reduct J. 2017 Aug 16;14(1):57. doi: 10.1186/s12954-017-0184-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk behaviour and infectious diseases in people with Having Ever Injected Drugs, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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 17 Sep 2020. 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 Sweden. 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?
Number of participants with injection risk behaviour (time frame: 2002-2012). 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 NCT02234167, which also lists 1 linked publication.
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 17 Sep 2020.