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A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial (SYNBASIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859935
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Henry J.C. de Vries, Public Health Service of Amsterdam

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date January 22, 2019
Actual Study Start Date  ICMJE September 1, 2016
Actual Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
Help seeking behavior [ Time Frame: one year ]
Does a personalised behaviour intervention comprising of targeted in depth screening on mental health problems and drug use and linkage to care increase help seeking behaviour among MSM who are at high risk for STIs and HIV.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
Risk behavior [ Time Frame: one year ]
Does a behaviour intervention comprising of targeted in depth screening on mental health problems and drug use and linkage to care decrease STI prevalence and risky sex (i.e. condom use/ number of partners/ number of unsafe partners/ amount anal sex/ recreational drug use/ stop visiting the STI clinic).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial
Official Title  ICMJE A SYNdemic BASed Co-located Linkage to Care INtervention for Men Who Have Sex With Men With High Risk Behavior: Design of a Randomized Controlled Trial
Brief Summary The purpose of this randomized controlled intervention study at the STI outpatient clinic of Amsterdam is to answer the following questions : Does a personalised behaviour intervention comprising of targeted in-depth screening on mental health problems and drug use and, in case identified, subsequent linkage to care increase help seeking behaviour, and decrease risk behaviour in MSM who are at high risk for STIs and HIV?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Risk Behavior
Intervention  ICMJE Behavioral: Screening and feedback
Screening via questionnaires on mental health problems and feedback on the questionnaires
Study Arms  ICMJE
  • No Intervention: Control group
    The control group will receive standard care - 3 monthly STI screening, motivational interviewing and counselling. Both groups will get questionnaires on mental health problems: ADHD, depression, anxiety disorder, alexithymia and sex and drug addiction.
  • Intervention group
    The intervention group will receive -besides standard care- additional questionnaires depending on their baseline questionnaires and in case of an indication for mental health problems, feedback and referral to relevant mental health and addiction care will be provided.
    Intervention: Behavioral: Screening and feedback
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 4, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2018
Actual Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • MSM
  • Sufficient understanding of Dutch or English and
  • 2 STIs in the last 24 months or a PEP treatment for HIV negative MSM

Exclusion Criteria:

  • Men will be excluded if they are not able to complete follow-up or otherwise deemed by clinic staff to be unsuited for participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02859935
Other Study ID Numbers  ICMJE synbasin 2.7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Henry J.C. de Vries, Public Health Service of Amsterdam
Study Sponsor  ICMJE Public Health Service of Amsterdam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry de Vries, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Public Health Service of Amsterdam
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP