Clinical trial NCT03186183: GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
Official title: GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Sexually Transmitted Infection
Health Behavior
Keywords: HIV prevention
Sexual health
Motivational interviewing
Information-Motivation-Behavioural skills model
Health promotion
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Health Initiative for Men
name: Regional HIV/AIDS Connection
name: AIDS Committee of Toronto
name: Gay ZONE
name: The Ottawa Hospital
name: University of Victoria
name: University of Windsor
name: Ottawa Hospital Research Institute
name: Canadian Institutes of Health Research (CIHR)
name: MAX Ottawa
First posted: 2017-06-14
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the number of serodiscordant condomless anal sex acts
timeFrame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Secondary outcomes:
measure: Change in the number of sexual partners
timeFrame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
measure: Change in the number of receptive condomless anal sex acts
timeFrame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
measure: Change in the number of insertive condomless anal sex acts
timeFrame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
measure: Change in HIV viral load status
timeFrame: Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up)
measure: Change in use of HIV pre-exposure prophylaxis (PrEP)
timeFrame: Present use (asked at baseline, post-treatment, and 3-month follow-up)
Other outcomes:
measure: Change in loneliness
timeFrame: Present loneliness (measured at baseline, post-treatment, and 3-month follow-up)
measure: Change in sexual compulsivity
timeFrame: Present sexual compulsivity (measured at baseline, post-treatment, and 3-month follow-up)
Locations:
city: Vancouver
country: Canada
facility: Health Initiative for Men
state: British Columbia
city: London
country: Canada
facility: Regional HIV/AIDS Connection
state: Ontario
city: Ottawa
country: Canada
facility: Immunodeficiency Clinic - The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Gay ZONE (Centretown Community Health Centre)
state: Ontario
city: Ottawa
country: Canada
facility: MAX Ottawa
state: Ontario
city: Toronto
country: Canada
facility: AIDS Committee of Toronto
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Trevor Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References: