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

Risk Behavior Clinical Trial

— SYNBASIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859935
• Other study ID #: synbasin 2.7
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2019
• Source: Public Health Service of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Risk Behavior

Intervention

Behavioral:
• Screening and feedback
Screening via questionnaires on mental health problems and feedback on the questionnaires

Locations

Country	Name	City	State
Netherlands	STI Clinic, Public Health Service Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Public Health Service of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk behavior	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