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

NCT ID: NCT03186183

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-07-17

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.

Conditions

HIV/AIDS; Sexually Transmitted Infection; Health Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GPS program

The individual GPS motivational interviewing counseling program has 4-6 sessions.

Week 1: information on sexually transmitted infections and HIV disclosure laws is reviewed. Participants are introduced to the sex diary, stress exercise, and stages of change model.

Week 2: a decisional balance exercise about the participant's current sexual behavior is completed and a behavioral goal is chosen.

Week 3: participants explore their greatest fears and hopes about the goal, and the importance of and their confidence in achieving it.

Week 4: the facilitator and participant identify triggers, automatic thoughts, counters, strategies, supports, and rewards pertaining to the pursuit of the goal and role play the new goal.

1-2 supplemental sessions may be added as needed.

Group Type: EXPERIMENTAL

GPS program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Health Initiative for Men

UNKNOWN

Sponsor Role: collaborator

Regional HIV/AIDS Connection

UNKNOWN

Sponsor Role: collaborator

AIDS Committee of Toronto

OTHER

Sponsor Role: collaborator

Gay ZONE

UNKNOWN

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

University of Victoria

OTHER

Sponsor Role: collaborator

University of Windsor

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

MAX Ottawa

UNKNOWN

Sponsor Role: collaborator

Toronto Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Trevor Hart

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trevor Hart, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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

Countries

Canada

Other Identifiers

REB 2016-282

Identifier Type: -

Identifier Source: org_study_id