Risk BehaviorGPSNCT02546271
A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men
A study testing GPS in people with Risk Behavior, run by Toronto Metropolitan University.
Trial summary
Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive gay and bisexual men, which takes place in a group counselling format. All participants provided written informed consent at the outset of the study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Risk Behavior
- What is being tested?
- GPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Nov 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in the study, participants had to:
- identify as male,
- report engaging in condomless anal sex with another male during the past 3 months,
- self-report an HIV-positive status,
- be over the age of 18 years old, and
- be able to speak and read in English.
Who cannot join
- Self-reported female gender,
- no condomless anal sex with another male during past 3 months,
- HIV-negative
About this study
Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive gay and bisexual men, which takes place in a group counselling format. All participants provided written informed consent at the outset of the study. Eligible participants filled out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS program, participants were scheduled to attend a 1-hour session to complete the same questionnaire package. Participants received an honorarium and a list of community resources, including mental health or substance use counseling services, at the end of each assessment. Participants also participated in a program evaluation interview at the 3-month follow-up assessment.
- Conditions
- Risk Behavior
- Being tested
- GPS
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPSBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | GPS program - an 8-week, peer-led group counselling program using motivational interviewing techniques. Receives: Behavioral: GPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serodiscordant condomless anal sex with a casual partner
Condomless anal sex with an HIV-negative or unknown serostatus casual partner
Measured: Past 3 months
Secondary outcomes (1)
Seroconcordant condonmless anal sex with a casual partner
Condomless anal sex with an HIV-positive casual partner
Measured: Past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMar 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT02546271
- Sponsor's protocol ID
- CIHR 194226
- Acronym
- GPS
- Status last verified
- Jul 2018
- First submitted
- 4 Sep 2015
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hart TA, Stratton N, Coleman TA, Wilson HA, Simpson SH, Julien RE, Hoe D, Leahy B, Maxwell J, Adam BD. A Pilot Trial of a Sexual Health Counseling Intervention for HIV-Positive Gay and Bisexual Men Who Report Anal Sex without Condoms. PLoS One. 2016 Apr 7;11(4):e0152762. doi: 10.1371/journal.pone.0152762. eCollection 2016.
PubMed 27054341
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02546271
- Acronym / sponsor ID
- GPS / CIHR 194226
- Conditions
- Risk Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Sep 2015 (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.
Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive gay and bisexual men, which takes place in a group counselling format. All participants provided written informed consent at the outset of the study. Eligible participants filled out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS program, participants were scheduled to attend a 1-hour session to complete the same questionnaire package. Participants received an honorarium and a list of community resources, including mental health or substance use counseling services, at the end of each assessment. Participants also participated in a program evaluation interview at the 3-month follow-up assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: GPSGPS program - an 8-week, peer-led group counselling program using motivational interviewing techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- identify as male,
- report engaging in condomless anal sex with another male during the past 3 months,
- self-report an HIV-positive status,
- be over the age of 18 years old, and
- be able to speak and read in English.
Key exclusion criteria (3 listed)
- Self-reported female gender,
- no condomless anal sex with another male during past 3 months,
- HIV-negative
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 |
|---|---|---|
| GPS | Behavioural | Treatment Group |
Primary outcome
Serodiscordant condomless anal sex with a casual partner
Time frame: Past 3 months
Condomless anal sex with an HIV-negative or unknown serostatus casual partner
1 secondary outcome
Seroconcordant condonmless anal sex with a casual partner
Time frame: Past 3 months
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 20 Jul 2018.
- Derived from this study: PubMed 27054341Hart TA, Stratton N, Coleman TA, Wilson HA, Simpson SH, Julien RE, Hoe D, Leahy B, Maxwell J, Adam BD. A Pilot Trial of a Sexual Health Counseling Intervention for HIV-Positive Gay and Bisexual Men Who Report Anal Sex without Condoms. PLoS One. 2016 Apr 7;11(4):e0152762. doi: 10.1371/journal.pone.0152762. eCollection 2016.
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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
Questions about this trial
What is this clinical trial studying?
A study testing GPS in people with Risk Behavior, run by Toronto Metropolitan University.
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 3 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Serodiscordant condomless anal sex with a casual partner (time frame: Past 3 months). 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 NCT02546271, which also lists 1 linked publication.
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 20 Jul 2018.