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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03186183
Enrollment
50
Registered
2017-06-14
Start date
2017-09-01
Completion date
2019-07-17
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, HIV/AIDS, Sexually Transmitted Infection

Keywords

HIV prevention, Sexual health, Motivational interviewing, Information-Motivation-Behavioural skills model, Health promotion

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.

Interventions

BEHAVIORALGPS 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.

Sponsors

Health Initiative for Men
CollaboratorUNKNOWN
Regional HIV/AIDS Connection
CollaboratorUNKNOWN
AIDS Committee of Toronto
CollaboratorOTHER
Gay ZONE
CollaboratorUNKNOWN
The Ottawa Hospital
CollaboratorOTHER
University of Victoria
CollaboratorOTHER
University of Windsor
CollaboratorOTHER
Ottawa Hospital Research Institute
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
MAX Ottawa
CollaboratorUNKNOWN
Toronto Metropolitan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the number of serodiscordant condomless anal sex actsPast 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

MeasureTime frameDescription
Change in the number of sexual partnersPast 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 the number of receptive condomless anal sex actsPast 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 actsPast 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 HIV viral load statusMost 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 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.

Other

MeasureTime frameDescription
Change in lonelinessPresent loneliness (measured at baseline, post-treatment, and 3-month follow-up)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.
Change in sexual compulsivityPresent sexual compulsivity (measured at baseline, post-treatment, and 3-month follow-up)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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026