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

NCT03186183 | Completed

• 1 other identifier: REB 2016-282
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in the number of sexual partners

  Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)

• Change in the number of receptive condomless anal sex acts

  Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)

• Change in the number of insertive condomless anal sex acts

  Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)

• Change in HIV viral load status

  Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up)

• Change in use of HIV pre-exposure prophylaxis (PrEP)

  Present use (asked at baseline, post-treatment, and 3-month follow-up)

Other Outcomes (2)

• Change in loneliness

  Present loneliness (measured at baseline, post-treatment, and 3-month follow-up)

• Change in sexual compulsivity

  Present sexual compulsivity (measured at baseline, post-treatment, and 3-month follow-up)

Study Arms (1)

GPS program

EXPERIMENTAL

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.

Behavioral: GPS program

Interventions

GPS program 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.

GPS program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identify as a man; transmen are welcome
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Health Initiative for Men: collaborator
• Regional HIV/AIDS Connection: collaborator
• AIDS Committee of Toronto: collaborator
• Gay ZONE: collaborator
• The Ottawa Hospital: collaborator
• University of Victoria: collaborator
• University of Windsor: collaborator
• Ottawa Hospital Research Institute: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• MAX Ottawa: collaborator

Study Sites (6)

Health Initiative for Men

Vancouver, British Columbia, V6E 1M7, Canada

Location

Regional HIV/AIDS Connection

London, Ontario, N6A 1C7, Canada

Location

Immunodeficiency Clinic - The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Gay ZONE (Centretown Community Health Centre)

Ottawa, Ontario, K2P 2N6, Canada

Location

MAX Ottawa

Ottawa, Ontario, Canada

Location

AIDS Committee of Toronto

Toronto, Ontario, M4Y 1Y5, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Health Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Trevor Hart, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 14, 2017
• Study Start: September 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: July 17, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)