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

This study is currently recruiting participants.
Verified September 2017 by Trevor Hart, Ryerson University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03186183
First Posted: June 14, 2017
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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)
Information provided by (Responsible Party):
Trevor Hart, Ryerson University
  Purpose
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.

Condition Intervention
HIV/AIDS Sexually Transmitted Infection Health Behavior Behavioral: GPS program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men

Resource links provided by NLM:


Further study details as provided by Trevor Hart, Ryerson University:

Primary Outcome Measures:
  • Change in the number of serodiscordant condomless anal sex acts [ Time Frame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up) ]
    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 [ Time Frame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up) ]
    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 [ Time Frame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up) ]
    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 [ Time Frame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up) ]
    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 [ Time Frame: Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up) ]
    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) [ Time Frame: Present use (asked at baseline, post-treatment, and 3-month follow-up) ]
    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.


Other Outcome Measures:
  • Change in loneliness [ Time Frame: Present loneliness (measured at baseline, post-treatment, and 3-month follow-up) ]
    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.

  • Change in sexual compulsivity [ Time Frame: Present sexual compulsivity (measured at baseline, post-treatment, and 3-month follow-up) ]
    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.


Estimated Enrollment: 50
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GPS program

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.

Behavioral: GPS program
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identify as a man; transmen are welcome
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186183


Contacts
Contact: Julia Vernon 416-979-5000 ext 1-2179 julia.vernon@psych.ryerson.ca
Contact: Trevor Hart, PhD 416-979-5000 ext 1-6192 trevor.hart@psych.ryerson.ca

Locations
Canada, British Columbia
Health Initiative for Men Not yet recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: Aaron Purdie    604-488-1001 ext 230    aaron@checkhimout.ca   
Principal Investigator: Nathan Lachowsky, PhD         
Canada, Ontario
Regional HIV/AIDS Connection Recruiting
London, Ontario, Canada, N6A 1C7
Contact: Christopher Sterling-Murphy    519-434-1601 ext 250    csterling-murphy@hivaidsconnection.ca   
Contact: Carin Fraser    519-434-1601 ext 228    cfraser@hivaidsconnection.ca   
Sub-Investigator: Meredith Fraser, PhD         
Sub-Investigator: Todd Coleman, PhD         
Immunodeficiency Clinic - The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Christopher Hnain    613-737-8899 ext 72424    chnain@ohri.ca   
Principal Investigator: Paul MacPherson, PhD, MD         
Gay ZONE (Centretown Community Health Centre) Recruiting
Ottawa, Ontario, Canada, K2P 2N6
Contact: Christopher Hnain    613-737-8899 ext 72424    chnain@ohri.ca   
Principal Investigator: Paul MacPherson, PhD, MD         
AIDS Committee of Toronto Recruiting
Toronto, Ontario, Canada, M4Y 1Y5
Contact: Rick Julien    416-340-8484 ext 277    rjulien@actoronto.org   
Contact: Scott Simpson    416-340-8484 ext 277    ssimpson@actoronto.org   
Sponsors and Collaborators
Ryerson University
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)
Investigators
Principal Investigator: Trevor Hart, PhD Ryerson University
  More Information

Responsible Party: Trevor Hart, Principal Investigator, Ryerson University
ClinicalTrials.gov Identifier: NCT03186183     History of Changes
Other Study ID Numbers: REB 2016-282
First Submitted: May 25, 2017
First Posted: June 14, 2017
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Trevor Hart, Ryerson University:
HIV prevention
Sexual health
Motivational interviewing
Information-Motivation-Behavioural skills model
Health promotion

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female