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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Health Behavior; Sexually Transmitted Infection
• Intervention / Treatment: Behavioral: GPS program

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6E 1M7
      • Health Initiative for Men
  • Ontario
    • London, Ontario, Canada, N6A 1C7
      • Regional HIV/AIDS Connection
    • Ottawa, Ontario, Canada, K1H 8L6
      • Immunodeficiency Clinic - The Ottawa Hospital
    • Ottawa, Ontario, Canada, K2P 2N6
      • Gay ZONE (Centretown Community Health Centre)
    • Ottawa, Ontario, Canada
      • MAX Ottawa
    • Toronto, Ontario, Canada, M4Y 1Y5
      • AIDS Committee of Toronto

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
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.	Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
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.	Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
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.	Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up)
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.	Present use (asked at baseline, post-treatment, and 3-month follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in loneliness	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.	Present loneliness (measured at baseline, post-treatment, and 3-month follow-up)
Change in sexual compulsivity	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.	Present sexual compulsivity (measured at baseline, post-treatment, and 3-month follow-up)

Collaborators and Investigators

• Sponsor: Ryerson University
• Collaborators: Canadian Institutes of Health Research (CIHR); Ottawa Hospital Research Institute; The Ottawa Hospital; University of Victoria; University of Windsor; Health Initiative for Men; Regional HIV/AIDS Connection; AIDS Committee of Toronto; Gay ZONE; MAX Ottawa
• Investigators: Principal Investigator: Trevor Hart, PhD, Ryerson University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): July 17, 2019

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Health promotion; Motivational interviewing; HIV prevention; Sexual health; Information-Motivation-Behavioural skills model
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: REB 2016-282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No