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Completed

NCT Number: NCT03186183

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Health Initiative for Men, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in the number of serodiscordant condomless anal sex acts

    Time frame: 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 outcomes

  1. Change in the number of sexual partners

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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 outcomes

  1. Change in loneliness

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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