NCT02234167

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

Longer than P75 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

April 1, 2002

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

11.7 years

First QC Date

April 4, 2014

Last Update Submit

September 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2002-2012

Secondary Outcomes (1)

  • Number of participants with infectious diseases

    2002-2012

Study Arms (1)

Risk behaviour and infectious diseases

OTHER

.(among IDU)

Behavioral: Risk behaviour and infectious diseases

Interventions

through counselling, testing vaccination

Also known as: biological and behavioural
Risk behaviour and infectious diseases

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Defined as an injecting drug user, in the prison and probation service and agree to anonymously participate

You may not qualify if:

  • Being defined as a non-drug user, non-injecting drug user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SHP

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Biological Products

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

April 4, 2014

First Posted

September 9, 2014

Study Start

April 1, 2002

Primary Completion

December 1, 2013

Study Completion

December 31, 2013

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations