- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02546271
A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men (GPS)
July 18, 2018 updated by: Trevor Hart, Ryerson University
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 Overview
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Self-reported female gender,
- no condomless anal sex with another male during past 3 months,
- HIV-negative
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
GPS program - an 8-week, peer-led group counselling program using motivational interviewing techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Past 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seroconcordant condonmless anal sex with a casual partner
Time Frame: Past 3 months
|
Condomless anal sex with an HIV-positive casual partner
|
Past 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Trevor A Hart, PhD, Ryerson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2009
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
September 4, 2015
First Submitted That Met QC Criteria
September 8, 2015
First Posted (Estimate)
September 10, 2015
Study Record Updates
Last Update Posted (Actual)
July 20, 2018
Last Update Submitted That Met QC Criteria
July 18, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR 194226
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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