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

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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

Study Description
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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?

Condition or disease Intervention/treatment Phase
Risk Behavior Behavioral: Screening and feedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Screening and feedback
Screening via questionnaires on mental health problems and feedback on the questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859935


Locations
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Netherlands
STI Clinic, Public Health Service Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
Public Health Service of Amsterdam
Investigators
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Principal Investigator: Henry de Vries, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Henry J.C. de Vries, Professor MD, PhD, Public Health Service of Amsterdam
ClinicalTrials.gov Identifier: NCT02859935    
Other Study ID Numbers: synbasin 2.7
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Henry J.C. de Vries, Public Health Service of Amsterdam:
HIV
drug abuse
MSM
 Risk behavior
Sexually transmitted diseases
Sexually transmitted infections