NCT02859935

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration 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

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

August 4, 2016

Last Update Submit

January 18, 2019

Conditions

Risk Behavior

Keywords

HIVdrug abuseMSMRisk behaviorSexually transmitted diseasesSexually transmitted infections

Outcome Measures

Primary Outcomes (1)

  • Help seeking behavior

    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 Outcomes (1)

  • Risk behavior

    one year

Study Arms (2)

Control group

NO INTERVENTION

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

OTHER

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

Interventions

Screening and feedbackBEHAVIORAL

Screening via questionnaires on mental health problems and feedback on the questionnaires

Intervention group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Men will be excluded if they are not able to complete follow-up or otherwise deemed by clinic staff to be unsuited for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

STI Clinic, Public Health Service Amsterdam

Amsterdam, Netherlands

Location

Related Publications (2)

  • Achterbergh RCA, van Rooijen MS, van den Brink W, Boyd A, de Vries HJC. Enhancing help-seeking behaviour among men who have sex with men at risk for sexually transmitted infections: the syn.bas.in randomised controlled trial. Sex Transm Infect. 2021 Feb;97(1):11-17. doi: 10.1136/sextrans-2020-054438. Epub 2020 Jul 31.

    PMID: 32737210DERIVED

  • Achterbergh RCA, van der Helm JJ, van den Brink W, de Vries HJC. Design of a syndemic based intervention to facilitate care for men who have sex with men with high risk behaviour: the syn.bas.in randomized controlled trial. BMC Infect Dis. 2017 Jun 6;17(1):398. doi: 10.1186/s12879-017-2474-x.

    PMID: 28587607DERIVED

MeSH Terms

Conditions

Risk-TakingSubstance-Related DisordersSexually Transmitted Diseases

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

BehaviorChemically-Induced DisordersMental DisordersCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Henry de Vries, MD, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MD, PhD

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)