Social AnxietyPhase 1NCT02045225
HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety
A Phase 1 study testing Reduction of social anxiety & substance use in gay/bi men in people with Social Anxiety and Substance Use, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Social Anxiety, Substance Use
- What is being tested?
- Reduction of social anxiety & substance use in gay/bi men
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Jun 2017
- Phase
- Phase 1
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-65 years
- male identified
- gay or bisexual identified
- experiencing social anxiety in sexual situations
- condomless anal sex with a casual (or non-monogamous) HIV-positive or unknown serostatus partner in the last 3 months
- consumption of alcohol and/or a recreational drug within 2 hours before sex or during sex within the last 3 months
Who cannot join
- younger than 18 or older than 65 years of age
- not male identified
- sexual orientation other than gay or bisexual
- no experiences of social anxiety in sexual situations
- severe mental illness
- already receiving psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An HIV Prevention Intervention for HIV-negative Men Who Have Sex With Men Via Reduction of Social Anxiety and Substance Use in Sexual Situations
Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Among MSM in Ontario, from 2001 to 2006, HIV diagnoses increased 26% (3). Given the alarmingly high HIV prevalence rates among MSM in North American cities, there is a critical need for HIV prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal situations, is a reliable risk factor for unprotected anal intercourse (UAI) among MSM (4 and 5). Social anxiety is highly modifiable via cognitive-behavioural therapy, a form of psychotherapy (6). Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM (7 and 8). As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM. This is a proposal to test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour.
Read the detailed description
The present study will provide pilot data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This pilot study will serve 3 related major objectives: 1) to provide data on the acceptability and feasibility of the intervention administered, 2) to provide pilot data testing the intervention, and 3) to provide data that will allow Dr. Hart and his team to apply to CIHR for a Phase II trial that will test the efficacy of the intervention relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations among MSM.
Participants attend 4 assessment sessions, during which they complete a series of interviews and questionnaires regarding social anxiety, substance use, and sexual risk behaviours. Participants also attend 10 sessions of counselling, where a therapist seeks to help the participant work towards reducing his anxiety in social and sexual situations and try to better manage his use of alcohol and drugs in sexual situations. The participant undergoes a baseline assessment, followed by 10 weekly counselling sessions, a post-treatment assessment, and 3- and 6-month follow-up assessments.
- Conditions
- Social Anxiety, Substance Use
- Being tested
- Reduction of social anxiety & substance use in gay/bi men
- Keywords
- social anxiety in sexual situations
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of social anxiety & substance use in gay/bi menBehavioural
The study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM built upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This study will test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour. Study objectives: 1) to provide data on the acceptability/feasibility of the intervention, 2) to provide data to test the intervention, and 3) to provide data that will allow for a RCT that will test intervention efficacy relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural therapy | Experimental | Reduction of social anxiety \& substance use in gay/bi men Receives: Behavioral: Reduction of social anxiety & substance use in gay/bi men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status
Sexual Behavior and Related Measures:
Sexual Risk Behavior and Related Assessment (self-report)
Measured: 3, 6, and 9 months following baseline assessment
Secondary outcomes (1)
Severity of social anxiety and instances substance use in sexual situations
Social Anxiety Measures:
Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Liebowitz Social Anxiety Scale (LSAS) Anxiety Disorders Interview Schedule (ADIS-DSM-IV) Brief Fear of Negative Evaluation Scale, Straightforward Items (BFNE-S)
Substance Use Measures:
The Alcohol Use Disorders Identification Test (AUDIT) Brief Michigan Alcohol Screening Test (BMAST) The Addictions Severity Index Lite (ASI-Lite)
Measured: 3, 6, and 9 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Hart, Toronto Metropolitan University
- Investigators
- Trevor A Hart, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045225
- Sponsor's protocol ID
- 201203HHP-279414-PB1ABAF146056
- Other IDs
- 201203HHP-279414
- Status last verified
- Mar 2020
- First submitted
- 24 May 2013
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Remis RS, Swantee C, Schiedel L, Liu J. Report on HIV/AIDS in Ontario. March, 2008. http://www.health.gov.on.ca/english/providers/pub/aids/reports/report_hivaids_ontario_2006.pdf.
Public Health Agency of Canada. (2010). HIV and AIDS in Canada: Surveillance report to December 31, 2009. http://www.phac-aspc.gc.ca/aids-sida/publication/index-eng.php#surveillance.
Hart TA, Heimberg RG. Social anxiety as a risk factor for unprotected intercourse among gay and bisexual male youth. AIDS Behav. 2005 Dec;9(4):505-12. doi: 10.1007/s10461-005-9021-2.
PubMed 16205961Hart TA, James CA, Purcell DW, Farber E. Social anxiety and HIV transmission risk among HIV-seropositive male patients. AIDS Patient Care STDS. 2008 Nov;22(11):879-86. doi: 10.1089/apc.2008.0085.
PubMed 19025482Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.
PubMed 18363421Semple SJ, Strathdee SA, Zians J, McQuaid J, Patterson TL. Psychosocial and behavioral correlates of anxiety symptoms in a sample of HIV-positive, methamphetamine-using men who have sex with men. AIDS Care. 2011 May;23(5):628-37. doi: 10.1080/09540121.2010.525608.
PubMed 21293993Elkington KS, Bauermeister JA, Zimmerman MA. Psychological distress, substance use, and HIV/STI risk behaviors among youth. J Youth Adolesc. 2010 May;39(5):514-27. doi: 10.1007/s10964-010-9524-7. Epub 2010 Mar 14.
PubMed 20229264
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An HIV Prevention Intervention for HIV-negative Men Who Have Sex With Men Via Reduction of Social Anxiety and Substance Use in Sexual Situations
- ClinicalTrials.gov ID
- NCT02045225
- Acronym / sponsor ID
- 201203HHP-279414-PB1ABAF146056
- Conditions
- Social Anxiety, Substance Use
- Keywords
- social anxiety in sexual situations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 24 Jan 2014 (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.
Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Among MSM in Ontario, from 2001 to 2006, HIV diagnoses increased 26% (3). Given the alarmingly high HIV prevalence rates among MSM in North American cities, there is a critical need for HIV prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal situations, is a reliable risk factor for unprotected anal intercourse (UAI) among MSM (4 and 5). Social anxiety is highly modifiable via cognitive-behavioural therapy, a form of psychotherapy (6). Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM (7 and 8). As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM. This is a proposal to test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour.
Detailed description
The present study will provide pilot data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This pilot study will serve 3 related major objectives: 1) to provide data on the acceptability and feasibility of the intervention administered, 2) to provide pilot data testing the intervention, and 3) to provide data that will allow Dr. Hart and his team to apply to CIHR for a Phase II trial that will test the efficacy of the intervention relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations among MSM.
Participants attend 4 assessment sessions, during which they complete a series of interviews and questionnaires regarding social anxiety, substance use, and sexual risk behaviours. Participants also attend 10 sessions of counselling, where a therapist seeks to help the participant work towards reducing his anxiety in social and sexual situations and try to better manage his use of alcohol and drugs in sexual situations. The participant undergoes a baseline assessment, followed by 10 weekly counselling sessions, a post-treatment assessment, and 3- and 6-month follow-up assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy | Experimental | Behavioral: Reduction of social anxiety & substance use in gay/bi menReduction of social anxiety \& substance use in gay/bi men |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-65 years
- male identified
- gay or bisexual identified
- experiencing social anxiety in sexual situations
- condomless anal sex with a casual (or non-monogamous) HIV-positive or unknown serostatus partner in the last 3 months
Key exclusion criteria (6 listed)
- younger than 18 or older than 65 years of age
- not male identified
- sexual orientation other than gay or bisexual
- no experiences of social anxiety in sexual situations
- severe mental illness
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 |
|---|---|---|
| Reduction of social anxiety & substance use in gay/bi menThe study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM built upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This study will test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour. Study objectives: 1) to provide data on the acceptability/feasibility of the intervention, 2) to provide data to test the intervention, and 3) to provide data that will allow for a RCT that will test intervention efficacy relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations. | Behavioural | Cognitive behavioural therapy |
Primary outcome
Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status
Time frame: 3, 6, and 9 months following baseline assessment
Sexual Behavior and Related Measures: Sexual Risk Behavior and Related Assessment (self-report)
1 secondary outcome
Severity of social anxiety and instances substance use in sexual situations
Time frame: 3, 6, and 9 months after baseline assessment
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 11 Mar 2020.
- BackgroundRemis RS, Swantee C, Schiedel L, Liu J. Report on HIV/AIDS in Ontario. March, 2008. http://www.health.gov.on.ca/english/providers/pub/aids/reports/report_hivaids_ontario_2006.pdf.
- BackgroundPublic Health Agency of Canada. (2010). HIV and AIDS in Canada: Surveillance report to December 31, 2009. http://www.phac-aspc.gc.ca/aids-sida/publication/index-eng.php#surveillance.
- Background: PubMed 16205961Hart TA, Heimberg RG. Social anxiety as a risk factor for unprotected intercourse among gay and bisexual male youth. AIDS Behav. 2005 Dec;9(4):505-12. doi: 10.1007/s10461-005-9021-2.
- Background: PubMed 19025482Hart TA, James CA, Purcell DW, Farber E. Social anxiety and HIV transmission risk among HIV-seropositive male patients. AIDS Patient Care STDS. 2008 Nov;22(11):879-86. doi: 10.1089/apc.2008.0085.
- Background: PubMed 18363421Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.
- Background: PubMed 21293993Semple SJ, Strathdee SA, Zians J, McQuaid J, Patterson TL. Psychosocial and behavioral correlates of anxiety symptoms in a sample of HIV-positive, methamphetamine-using men who have sex with men. AIDS Care. 2011 May;23(5):628-37. doi: 10.1080/09540121.2010.525608.
- Background: PubMed 20229264Elkington KS, Bauermeister JA, Zimmerman MA. Psychological distress, substance use, and HIV/STI risk behaviors among youth. J Youth Adolesc. 2010 May;39(5):514-27. doi: 10.1007/s10964-010-9524-7. Epub 2010 Mar 14.
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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.
Trevor A Hart, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reduction of social anxiety & substance use in gay/bi men in people with Social Anxiety and Substance Use, run by Toronto Metropolitan University at 1 site in Canada.
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 6 inclusion and 6 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 11 Mar 2020. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status (time frame: 3, 6, and 9 months following baseline assessment). 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 NCT02045225, which also lists 7 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 11 Mar 2020.