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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03186183
Other study ID # REB 2016-282
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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