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

January 18, 2019 updated by: Henry J.C. de Vries, Public Health Service of Amsterdam

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • STI Clinic, Public Health Service Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Service of Amsterdam

Investigators

  • Principal Investigator: Henry de Vries, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • synbasin 2.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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