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GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men

Primary Purpose

HIV/AIDS, Sexually Transmitted Infection, Health Behavior

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

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV prevention, Sexual health, Motivational interviewing, Information-Motivation-Behavioural skills model, Health promotion

Eligibility Criteria

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

Inclusion Criteria:

  • aged 18 years or older
  • self-identify as a man
  • self-identify as gay, bisexual, queer, same-gender-loving, or a man who has sex with men
  • report having engaged in condomless anal sex in the last 3 months
  • able to speak, read, and aurally comprehend English
  • depending on the study site, report HIV-negative or HIV-positive status

Sites / Locations

  • Health Initiative for Men
  • Regional HIV/AIDS Connection
  • Immunodeficiency Clinic - The Ottawa Hospital
  • Gay ZONE (Centretown Community Health Centre)
  • MAX Ottawa
  • AIDS Committee of Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GPS program

Arm Description

The individual GPS motivational interviewing counseling program has 4-6 sessions. Week 1: information on sexually transmitted infections and HIV disclosure laws is reviewed. Participants are introduced to the sex diary, stress exercise, and stages of change model. Week 2: a decisional balance exercise about the participant's current sexual behavior is completed and a behavioral goal is chosen. Week 3: participants explore their greatest fears and hopes about the goal, and the importance of and their confidence in achieving it. Week 4: the facilitator and participant identify triggers, automatic thoughts, counters, strategies, supports, and rewards pertaining to the pursuit of the goal and role play the new goal. 1-2 supplemental sessions may be added as needed.

Outcomes

Primary Outcome Measures

Change in the number of serodiscordant condomless anal sex acts
Participants will be asked to report the number of times they engaged in anal sex in the without a condom with a partner of opposite or unknown HIV status in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.

Secondary Outcome Measures

Change in the number of sexual partners
Participants will be asked to report the number of sexual partners they had who are HIV-positive, HIV-negative, and of unknown HIV status in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Change in the number of receptive condomless anal sex acts
Participants will be asked to report the number of times they engaged in receptive anal sex without a condom in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Change in the number of insertive condomless anal sex acts
Participants will be asked to report the number of times they engaged in insertive anal sex without a condom in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Change in HIV viral load status
HIV-positive participants will be asked to report whether they had a detectable or undetectable HIV viral load at their last viral load test as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Change in use of HIV pre-exposure prophylaxis (PrEP)
For HIV-negative participants, participants will be asked whether they use HIV PrEP as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.

Full Information

First Posted
May 25, 2017
Last Updated
March 9, 2020
Sponsor
Toronto Metropolitan University
Collaborators
Health Initiative for Men, Regional HIV/AIDS Connection, AIDS Committee of Toronto, Gay ZONE, The Ottawa Hospital, University of Victoria, University of Windsor, Ottawa Hospital Research Institute, Canadian Institutes of Health Research (CIHR), MAX Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT03186183
Brief Title
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
Official Title
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Health Initiative for Men, Regional HIV/AIDS Connection, AIDS Committee of Toronto, Gay ZONE, The Ottawa Hospital, University of Victoria, University of Windsor, Ottawa Hospital Research Institute, Canadian Institutes of Health Research (CIHR), MAX Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
GPS is a sexual health promotion and HIV prevention peer-delivered counselling program. The GPS program has 4 parts: information provision about HIV and sexually transmitted infections, motivational interviewing counselling, sexual health behavioural skills building, and linkage to care. The adaptation grant has three goals: 1) to establish a multi-region and multi-sectoral team that can deliver the revised program across a variety of settings, 2) to learn how best to deliver this program as individual counselling program and also how to adapt this program for HIV-negative MSM, and 3) to pilot the individual program in 5 settings across Ontario and British Columbia. The research team will evaluate the pilot adaptation through mixed methods, employing a quantitative questionnaire and one-on-one semi-structured interviews.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Sexually Transmitted Infection, Health Behavior
Keywords
HIV prevention, Sexual health, Motivational interviewing, Information-Motivation-Behavioural skills model, Health promotion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GPS program
Arm Type
Experimental
Arm Description
The individual GPS motivational interviewing counseling program has 4-6 sessions. Week 1: information on sexually transmitted infections and HIV disclosure laws is reviewed. Participants are introduced to the sex diary, stress exercise, and stages of change model. Week 2: a decisional balance exercise about the participant's current sexual behavior is completed and a behavioral goal is chosen. Week 3: participants explore their greatest fears and hopes about the goal, and the importance of and their confidence in achieving it. Week 4: the facilitator and participant identify triggers, automatic thoughts, counters, strategies, supports, and rewards pertaining to the pursuit of the goal and role play the new goal. 1-2 supplemental sessions may be added as needed.
Intervention Type
Behavioral
Intervention Name(s)
GPS program
Intervention Description
GPS is a sexual health promotion and HIV prevention program. It has 4 components: provision of information on HIV and sexually transmitted infections, motivational interviewing counselling, sexual health behavioural skills building, and linkage to care in the local community (e.g., referrals to medical, social service, social, mental health, and substance use programs). Among HIV-positive men who have sex with men (MSM) GPS is associated with positive health outcomes including decreased likelihood of condomless anal sex (CAS), particularly CAS with serodiscordant partners. GPS is also associated with decreased fear of being rejected for insisting on condom use and increased condom use self-efficacy.
Primary Outcome Measure Information:
Title
Change in the number of serodiscordant condomless anal sex acts
Description
Participants will be asked to report the number of times they engaged in anal sex in the without a condom with a partner of opposite or unknown HIV status in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Secondary Outcome Measure Information:
Title
Change in the number of sexual partners
Description
Participants will be asked to report the number of sexual partners they had who are HIV-positive, HIV-negative, and of unknown HIV status in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Title
Change in the number of receptive condomless anal sex acts
Description
Participants will be asked to report the number of times they engaged in receptive anal sex without a condom in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Title
Change in the number of insertive condomless anal sex acts
Description
Participants will be asked to report the number of times they engaged in insertive anal sex without a condom in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Title
Change in HIV viral load status
Description
HIV-positive participants will be asked to report whether they had a detectable or undetectable HIV viral load at their last viral load test as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up)
Title
Change in use of HIV pre-exposure prophylaxis (PrEP)
Description
For HIV-negative participants, participants will be asked whether they use HIV PrEP as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Present use (asked at baseline, post-treatment, and 3-month follow-up)
Other Pre-specified Outcome Measures:
Title
Change in loneliness
Description
Measured using the University of California, Los Angeles Loneliness Scale, which is part of the self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Present loneliness (measured at baseline, post-treatment, and 3-month follow-up)
Title
Change in sexual compulsivity
Description
Measured using the Sexual Compulsivity Scale, which is part of the self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.
Time Frame
Present sexual compulsivity (measured at baseline, post-treatment, and 3-month follow-up)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-identify as a man; transmen are welcome
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 years or older self-identify as a man self-identify as gay, bisexual, queer, same-gender-loving, or a man who has sex with men report having engaged in condomless anal sex in the last 3 months able to speak, read, and aurally comprehend English depending on the study site, report HIV-negative or HIV-positive status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor Hart, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Initiative for Men
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
Regional HIV/AIDS Connection
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 1C7
Country
Canada
Facility Name
Immunodeficiency Clinic - The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Gay ZONE (Centretown Community Health Centre)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2P 2N6
Country
Canada
Facility Name
MAX Ottawa
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
AIDS Committee of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1Y5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men

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