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A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men (GPS)

Primary Purpose

Risk Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GPS
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Risk Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

In order to be eligible to participate in the study, participants had to:

  1. identify as male,
  2. report engaging in condomless anal sex with another male during the past 3 months,
  3. self-report an HIV-positive status,
  4. be over the age of 18 years old, and
  5. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

    GPS program - an 8-week, peer-led group counselling program using motivational interviewing techniques.

    Outcomes

    Primary Outcome Measures

    Serodiscordant condomless anal sex with a casual partner
    Condomless anal sex with an HIV-negative or unknown serostatus casual partner

    Secondary Outcome Measures

    Seroconcordant condonmless anal sex with a casual partner
    Condomless anal sex with an HIV-positive casual partner

    Full Information

    First Posted
    September 4, 2015
    Last Updated
    July 18, 2018
    Sponsor
    Toronto Metropolitan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02546271
    Brief Title
    A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men
    Acronym
    GPS
    Official Title
    A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (Actual)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Toronto Metropolitan University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Risk Behavior

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    GPS program - an 8-week, peer-led group counselling program using motivational interviewing techniques.
    Intervention Type
    Behavioral
    Intervention Name(s)
    GPS
    Primary Outcome Measure Information:
    Title
    Serodiscordant condomless anal sex with a casual partner
    Description
    Condomless anal sex with an HIV-negative or unknown serostatus casual partner
    Time Frame
    Past 3 months
    Secondary Outcome Measure Information:
    Title
    Seroconcordant condonmless anal sex with a casual partner
    Description
    Condomless anal sex with an HIV-positive casual partner
    Time Frame
    Past 3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Trevor A Hart, PhD
    Organizational Affiliation
    Toronto Metropolitan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27054341
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://gaypozsex.org
    Description
    Program website

    Learn more about this trial

    A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men

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