Risk BehaviorSYNBASINNCT02859935
A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial
A study testing Screening and feedback in people with Risk Behavior, run by Public Health Service of Amsterdam at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior
- What is being tested?
- Screening and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2016to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MSM
- Sufficient understanding of Dutch or English and
- 2 STIs in the last 24 months or a PEP treatment for HIV negative MSM
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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?
- Conditions
- Risk Behavior
- Being tested
- Screening and feedback
- Keywords
- HIV, drug abuse, MSM, Risk behavior, Sexually transmitted diseases, Sexually transmitted infections
- Medical subject headings
- Risk-Taking, Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and feedbackBehavioural
Screening via questionnaires on mental health problems and feedback on the questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 | 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. Receives: Behavioral: Screening and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Service of Amsterdam
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Henry J.C. de Vries, Public Health Service of Amsterdam
- Investigators
- Henry de Vries, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859935
- Sponsor's protocol ID
- synbasin 2.7
- Acronym
- SYNBASIN
- Status last verified
- Jan 2019
- First submitted
- 4 Aug 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32737210Achterbergh 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.
PubMed 28587607
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02859935
- Acronym / sponsor ID
- SYNBASIN / synbasin 2.7
- Conditions
- Risk Behavior
- Keywords
- HIV, drug abuse, MSM, Risk behavior, Sexually transmitted diseases, Sexually transmitted infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Public Health Service of AmsterdamOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 | Behavioral: Screening and feedbackThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MSM
- Sufficient understanding of Dutch or English and
- 2 STIs in the last 24 months or a PEP treatment for HIV negative MSM
Key exclusion criteria (1 listed)
- Men will be excluded if they are not able to complete follow-up or otherwise deemed by clinic staff to be unsuited for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and feedbackScreening via questionnaires on mental health problems and feedback on the questionnaires | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Risk behavior
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 32737210Achterbergh 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.
- Derived from this study: PubMed 28587607Achterbergh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry de Vries, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and feedback in people with Risk Behavior, run by Public Health Service of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Help seeking behavior (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02859935, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.