HIV/AIDSNCT03186183
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
A study testing GPS program in people with HIV/AIDS and Sexually Transmitted Infection, run by Toronto Metropolitan University at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV/AIDS, Sexually Transmitted Infection, Health Behavior
- What is being tested?
- GPS program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Sep 2017to 17 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Regional HIV/AIDS Connection
London, Ontario, N6A 1C7
Immunodeficiency Clinic - The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Gay ZONE (Centretown Community Health Centre)
Ottawa, Ontario, K2P 2N6
MAX Ottawa
Ottawa, Ontario
AIDS Committee of Toronto
Toronto, Ontario, M4Y 1Y5
Health Initiative for Men
Vancouver, British Columbia, V6E 1M7
About this study
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
- Being tested
- GPS program
- Keywords
- HIV prevention, Sexual health, Motivational interviewing, Information-Motivation-Behavioural skills model, Health promotion
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GPS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Secondary outcomes (5)
Change in the number of sexual partners
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.
Measured: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Change in the number of receptive condomless anal sex acts
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.
Measured: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Change in the number of insertive condomless anal sex acts
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.
Measured: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
Change in HIV viral load status
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.
Measured: Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up)
Change in use of HIV pre-exposure prophylaxis (PrEP)
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.
Measured: Present use (asked at baseline, post-treatment, and 3-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Sep 2017
- Primary completion31 Mar 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Trevor Hart, Toronto Metropolitan University
- Investigators
- Trevor Hart, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186183
- Sponsor's protocol ID
- REB 2016-282
- Status last verified
- Mar 2020
- First submitted
- 25 May 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men
- ClinicalTrials.gov ID
- NCT03186183
- Acronym / sponsor ID
- REB 2016-282
- Conditions
- HIV/AIDS, Sexually Transmitted Infection, Health Behavior
- Keywords
- HIV prevention, Sexual health, Motivational interviewing, Information-Motivation-Behavioural skills model, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPS program | Experimental | Behavioral: GPS programThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPS programGPS 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. | Behavioural | GPS program |
Primary outcome
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.
5 secondary outcomes
Change in the number of sexual partners
Time frame: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)
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)
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)
Change in HIV viral load status
Time frame: Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up)
Change in use of HIV pre-exposure prophylaxis (PrEP)
Time frame: Present use (asked at baseline, post-treatment, and 3-month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trevor Hart, PhD principal investigator
Toronto Metropolitan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPS program in people with HIV/AIDS and Sexually Transmitted Infection, run by Toronto Metropolitan University at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.