ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT03186183
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : July 20, 2018
Sponsor:
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
Information provided by (Responsible Party):
Trevor Hart, Ryerson University

May 25, 2017
June 14, 2017
July 20, 2018
September 1, 2017
March 31, 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03186183 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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.
Same as current
 
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HIV/AIDS
  • Sexually Transmitted Infection
  • Health Behavior
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.
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.

Intervention: Behavioral: GPS program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Same as current
March 31, 2019
March 31, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Self-identify as a man; transmen are welcome
18 Years and older   (Adult, Older Adult)
No
Contact: Samer Lazkani 416-979-5000 ext 1-2179 samer.lazkani@psych.ryerson.ca
Contact: Trevor Hart, PhD 416-979-5000 ext 1-6192 trevor.hart@psych.ryerson.ca
Canada
 
 
NCT03186183
REB 2016-282
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Trevor Hart, Ryerson University
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)
  • MAX Ottawa
Principal Investigator: Trevor Hart, PhD Ryerson University
Ryerson University
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP