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

NCT ID: NCT02859935

Last Updated: 2019-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-09-01

Brief Summary

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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

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Conditions

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Risk Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Screening and feedback

Intervention Type BEHAVIORAL

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

Interventions

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Screening and feedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Service of Amsterdam

OTHER_GOV

Sponsor Role lead

Responsible Party

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Henry J.C. de Vries

Professor MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry de Vries, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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STI Clinic, Public Health Service Amsterdam

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 32737210 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28587607 (View on PubMed)

Other Identifiers

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synbasin 2.7

Identifier Type: -

Identifier Source: org_study_id

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