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

Study Overview
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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?

Official Title
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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

Conditions
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Risk Behavior

Intervention / Treatment
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* Behavioral: Screening and feedback


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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<br>* Screening via questionnaires on mental health problems and feedback on the questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, drug abuse, MSM, Risk behavior, Sexually transmitted diseases, Sexually transmitted infections