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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186183
• Other study ID #: REB 2016-282
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 17, 2019

Study information

• Verified date: March 2020
• Source: Ryerson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 17, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• HIV/AIDS
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

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.

Locations

Country	Name	City	State
Canada	Regional HIV/AIDS Connection	London	Ontario
Canada	Gay ZONE (Centretown Community Health Centre)	Ottawa	Ontario
Canada	Immunodeficiency Clinic - The Ottawa Hospital	Ottawa	Ontario
Canada	MAX Ottawa	Ottawa	Ontario
Canada	AIDS Committee of Toronto	Toronto	Ontario
Canada	Health Initiative for Men	Vancouver	British Columbia

Sponsors (11)

Lead Sponsor	Collaborator
Ryerson University	AIDS Committee of Toronto, Canadian Institutes of Health Research (CIHR), Gay ZONE, Health Initiative for Men, MAX Ottawa, Ottawa Hospital Research Institute, Regional HIV/AIDS Connection, The Ottawa Hospital, University of Victoria, University of Windsor

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)