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

Public Health Service of Amsterdam

Status: Completed

Conditions: Risk Behavior

Treatments: Behavioral: Screening and feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02859935

synbasin 2.7

Details and patient eligibility

About

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?

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Screening and feedback