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

Sponsor
Ryerson University (Other)
Overall Status
Completed
CT.gov ID
NCT03186183
Collaborator
Health Initiative for Men (Other), Regional HIV/AIDS Connection (Other), AIDS Committee of Toronto (Other), Gay ZONE (Other), The Ottawa Hospital (Other), University of Victoria (Other), University of Windsor (Other), Ottawa Hospital Research Institute (Other), Canadian Institutes of Health Research (CIHR) (Other), MAX Ottawa (Other)
50
6
1
22.5
8.3
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: GPS program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Jul 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in the number of serodiscordant condomless anal sex acts [Past 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 Outcome Measures

  1. Change in the number of sexual partners [Past 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.

  2. Change in the number of receptive condomless anal sex acts [Past 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.

  3. Change in the number of insertive condomless anal sex acts [Past 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.

  4. Change in HIV viral load status [Most 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.

  5. 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 Outcome Measures

  1. Change in loneliness [Present 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.

  2. Change in sexual compulsivity [Present 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Health Initiative for Men Vancouver British Columbia Canada V6E 1M7
2 Regional HIV/AIDS Connection London Ontario Canada N6A 1C7
3 Immunodeficiency Clinic - The Ottawa Hospital Ottawa Ontario Canada K1H 8L6
4 Gay ZONE (Centretown Community Health Centre) Ottawa Ontario Canada K2P 2N6
5 MAX Ottawa Ottawa Ontario Canada
6 AIDS Committee of Toronto Toronto Ontario Canada M4Y 1Y5

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Trevor Hart, PhD, Ryerson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trevor Hart, Principal Investigator, Ryerson University
ClinicalTrials.gov Identifier:
NCT03186183
Other Study ID Numbers:
  • REB 2016-282
First Posted:
Jun 14, 2017
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Trevor Hart, Principal Investigator, Ryerson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2020