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

Not Applicable

Completed

• Conditions: HIV/AIDS; Sexually Transmitted Infection; Health Behavior

• Registration Number: NCT03186183
• Lead Sponsor: Toronto Metropolitan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Study Start: 2017-09-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-07-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in the number of serodiscordant condomless anal sex acts	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

Name	Time	Method
Change in the number of sexual partners	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 HIV viral load status	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 the number of receptive condomless anal sex acts	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	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 use of HIV pre-exposure prophylaxis (PrEP)	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.

Trial Locations

Locations (6)

Health Initiative for Men; 🇨🇦 Vancouver, British Columbia, Canada

Regional HIV/AIDS Connection; 🇨🇦 London, Ontario, Canada

Immunodeficiency Clinic - The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Gay ZONE (Centretown Community Health Centre); 🇨🇦 Ottawa, Ontario, Canada

MAX Ottawa; 🇨🇦 Ottawa, Ontario, Canada

AIDS Committee of Toronto; 🇨🇦 Toronto, Ontario, Canada