A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial (SYNBASIN)
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|ClinicalTrials.gov Identifier: NCT02859935|
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : January 22, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Risk Behavior||Behavioral: Screening and feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||September 1, 2018|
|Actual Study Completion Date :||September 1, 2018|
No Intervention: 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.
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
Screening via questionnaires on mental health problems and feedback on the questionnaires
- Help seeking behavior [ Time Frame: one year ]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.
- Risk behavior [ Time Frame: one year ]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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Sufficient understanding of Dutch or English and
- 2 STIs in the last 24 months or a PEP treatment for HIV negative MSM
- Men will be excluded if they are not able to complete follow-up or otherwise deemed by clinic staff to be unsuited for participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859935
|STI Clinic, Public Health Service Amsterdam|
|Principal Investigator:||Henry de Vries, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Responsible Party:||Henry J.C. de Vries, Professor MD, PhD, Public Health Service of Amsterdam|
|Other Study ID Numbers:||
|First Posted:||August 9, 2016 Key Record Dates|
|Last Update Posted:||January 22, 2019|
|Last Verified:||January 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Sexually transmitted diseases
Sexually transmitted infections