Pre-Exposure Prophylaxis (PrEP)NCT06710171
Filling Gaps in the HIV Pre-exposure Prophylaxis Cascade Through Counseling
A study testing Counseling and List of resources in people with Pre-Exposure Prophylaxis (PrEP) and Counseling, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This study s objective is to test the acceptability and feasibility of a guide to facilitate counseling about HIV prevention, focusing on HIV pre-exposure prophylaxis (PrEP). PrEP is a medication taken by HIV-negative persons to avoid an HIV infection. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis (PrEP), Counseling, Sexual and Gender Minorities
- What is being tested?
- Counseling and List of resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2025to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Eligible participants at the provider level ('provider-participants') will be nurses, nurse practitioners, counselors and physicians working at sexual health clinics, public health clinics and primary care practices, with or without experience giving PrEP counseling.
1A. Inclusion criteria for provider-participants:
- For practicing health-care professionals, hold a valid license to practice in Ontario (this includes resident physicians)
- Anticipate encountering a minimum of five PrEP-eligible GBM and TGNC eligible for PrEP in the three months after enrolling in the study 1B. Exclusion criteria for provider-participants
- Anticipate to stop working at their current practice site before the end of the study 2A. Inclusion criteria for user-participants
- Be \> 19 years of age
- Self-identify as a gender different from cisgender woman
- Be presenting to their provider for sexual health/HIV testing or any other services
- Not having used PrEP in the three months prior to enrollment
- Having clinical indication for PrEP as per the Canadian PrEP guideline (i.e.: -
- Report having condomless anal sex with a man in the preceding 6 months plus any of the following: syphilis in the past year, rectal gonorrhea, LGV or chlamydia in the past year, use of PEP at least twice, ongoing sexual relationship with a person living with HIV with detectable viral load, or HIRI-MSM score \> 11 if available). 2B. Exclusion criteria for user-participants
- User-participants who have already received an invitation to participate in the study and declined will not be included since that means they would have received the intervention or the control in the past.
- Users who request getting on PrEP due to high self-perceived risk despite not meeting the clinical criteria specified above, will not be included.
- Not being able to communicate in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oscar Javier Pico Espinosa, MD MSPH PHD contact
Canada1 site
Options Lab
Toronto, Ontario, M5B 1T8
Katherine Griffin, Manager, 416-864-6060 ext. 77476, katherine.griffin@unityhealth.to
Darrell H.S. Tan, MD, FRCPC, PHD
About this study
Official title: Filling Gaps in the PrEP Cascade: User-centered Counseling About HIV Pre-exposure Prophylaxis and Linkage to Care for Gay, Bisexual and Other Men Who Have Sex with Men
This study s objective is to test the acceptability and feasibility of a guide to facilitate counseling about HIV prevention, focusing on HIV pre-exposure prophylaxis (PrEP). PrEP is a medication taken by HIV-negative persons to avoid an HIV infection.
Healthcare providers (including but not limited to physicians and nurses) who see gay, bisexual and other men who have sex with men (GBM) will be randomly assigned to completing a short online training versus continuing their usual activities.
Read more
The online training consists of modules containing brief information about PrEP, and about how to address concerns and difficulties that GBM face to get PrEP and to take care of their sexual health.
The investigators will ask healthcare providers to answer questionnaires before and after the research activities take place, and a member of the research team will interview some of them at the end.
Every time a healthcare provider has a counseling session with a GBM, they will facilitate putting a research coordinator in touch with the person receiving the counseling. Those GBM will also be asked to fill out questionnaires.
These activities will take place in the province of Ontario, Canada.
Read the detailed description
Our research questions are: (1) Is a training program for PrEP acceptable for healthcare providers, measured by perceived advantage of applying the recommendations learned in the program, compared to current practice? (2) Is a training program for PrEP feasible for healthcare providers, measured by intention to continue applying the recommendations after the study conclusion? And (3) What is the anticipated effectiveness of a training program at increasing the proportion of PrEP-eligible GBM and TGNC who start PrEP within one month of a counseling session with a healthcare provider, compared to passive referral to existing resources?
In this open-label cluster randomized pilot trial, the investigators will randomize consenting providers to undergo an online self-paced training on brief user-centered PrEP counseling vs only receiving a list of available resources. The goal is to enroll a range of different healthcare provider types working in both urban and suburban settings, and in different work settings. Recruitment of user-participants will be facilitated by participating providers, but done by a research coordinator.
Randomization and inclusion of provider-participants is expected to start in October 2024 and will continue through February 2025. Data collection (questionnaires and interviews) will continue beyond that period for provider-participants, as well as for user-participants whose enrolment occurs during the specified recruitment dates.
The qualitative component will explore implementation considerations from the perspective of provider-participants. The investigators will do focus groups (of approximately one hour, variable size) and offer the possibility of doing individuals interviews (of approximately 30-45 minutes) if they cannot attend the focus groups.
In the analysis stage, counts and proportions will be used to describe categorical and dichotomous variables. Mean and standard deviations or median and interquartile range will be used to describe continuous normally and non-normally distributed variables respectively. For the anticipated effectiveness outcome, the intra-cluster correlation coefficient (ICC) among patient-participants will be calculated. For that purpose, our analysis will be a generalized linear mixed model (GLMM) with logit link to estimate the effect of using the training program on the probability of user-participants starting (or re-starting) PrEP, while accounting for clustering of user-participants within the respective providers.
- Being tested
- Counseling, List of resources
- Keywords
- gay, men who have sex with men, bisexual, HIV PrEP, Pre-exposure prophylaxis, primary care, counseling, pilot trial, HIV prevention, sexual health
- Medical subject headings
- Coitus, Homosexuality, Bisexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
The intervention consists of using a theory-informed approach to user-centered brief counselling about PrEP uptake, designed specifically to help busy front-line providers in public health, sexual health and primary care settings advance clients along the PrEP cascade (specifically, supporting clients who meet evidence-based criteria for PrEP in accepting provider recommendations to use it) and provide linkage to care for related conditions.
The intervention will be delivered to GBM through participating healthcare providers who would have completed an online training designed by the research team.
List of resourcesOther
This list includes webpages which contain generic information about GBMs sexual health, PrEP, mental health, information about province-wide info lines for the general public about sexual health and/or educational resources for providers.
| Study group | Role | What they receive |
|---|---|---|
| Online training about counseling GBM about HIV prevention with a focus on PrEP | Active comparator | The intervention at the user level will consist of brief counseling by the participating provider about PrEP and tailored linkage to available information resources or services. This will be delivered through healthcare providers in the intervention arm, who would have completed a 60-minute online training designed by the research team.
The intervention consists of using a theory-informed approach to user-centered brief counselling about PrEP uptake, designed specifically to help busy front-line providers in public health, sexual health and primary care settings advance clients along the PrEP cascade (specifically, supporting clients who meet evidence-based criteria for PrEP in accepting provider recommendations to use it) and provide linkage to care for related conditions. Receives: Behavioral: Counseling; Other: List of resources |
| Care as usual | Other | Care as usual plus a list of available community resources related to HIV prevention and/or sexual health relevant to GBM Receives: Other: List of resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Proportion of provider-participants who indicate they believe using the recommendations of the training program is no different, somewhat better or significantly better than their current practice, measured with a Likert scale.
Measured: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained using qualitative interviews (to take place within a month after the 3-month follow up)
Secondary outcomes (5)
Feasibility - trialability
Proportion of provider-participants who indicate they are somewhat likely or very likely to use the recommendations of the training program in the future, measured with a Likert scale
Measured: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained from of qualitative interviews, which will take place within one month after the 3-month follow up.
Feasibility - complexity
Ease of use of the training package (using a Likert scale). Answering somewhat easy or very easy.
Measured: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained from of qualitative interviews, which will take place within one month after the 3-month follow up.
Feasibility - recruitment
Number of providers consenting to participate during the planned enrollment period (October to January)
Measured: Measured at baseline
Feasibility - retention
Proportion of provider-participants retained in the study after three months, out of provider-participants who start the training
Measured: At the 3-month follow up of participating healthcare providers
Anticipated effectiveness
Proportion of user-participants who start (or re-start) PrEP within one month after the initial encounter
Measured: At the patient level, after each counseling session and at the 1 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 posted29 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure Prophylaxis (PrEP)Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized pilot trial: healthcare providers will be randomized to either of the two arms and their clients; will then answer questionnaires.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darrell H.S. Tan, MD, FRCPC, PHD, Principal investigator, St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710171
- Sponsor's protocol ID
- 23-177
- Other IDs
- EFP-1129-BNG
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be stored at St. Michael\'s hospital, a research and teaching site which hosts trainees at different levels working in various research projects. Data collected in this study will be used to support various research activities (abstracts, publications, presentations) by the research team and future trainees.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Filling Gaps in the PrEP Cascade: User-centered Counseling About HIV Pre-exposure Prophylaxis and Linkage to Care for Gay, Bisexual and Other Men Who Have Sex with Men
- ClinicalTrials.gov ID
- NCT06710171
- Acronym / sponsor ID
- 23-177
- Keywords
- gay, men who have sex with men, bisexual, HIV PrEP, Pre-exposure prophylaxis, primary care, counseling, pilot trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Nov 2024 (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.
This study s objective is to test the acceptability and feasibility of a guide to facilitate counseling about HIV prevention, focusing on HIV pre-exposure prophylaxis (PrEP). PrEP is a medication taken by HIV-negative persons to avoid an HIV infection.
Healthcare providers (including but not limited to physicians and nurses) who see gay, bisexual and other men who have sex with men (GBM) will be randomly assigned to completing a short online training versus continuing their usual activities.
The online training consists of modules containing brief information about PrEP, and about how to address concerns and difficulties that GBM face to get PrEP and to take care of their sexual health.
The investigators will ask healthcare providers to answer questionnaires before and after the research activities take place, and a member of the research team will interview some of them at the end.
Every time a healthcare provider has a counseling session with a GBM, they will facilitate putting a research coordinator in touch with the person receiving the counseling. Those GBM will also be asked to fill out questionnaires.
These activities will take place in the province of Ontario, Canada.
Detailed description
Our research questions are: (1) Is a training program for PrEP acceptable for healthcare providers, measured by perceived advantage of applying the recommendations learned in the program, compared to current practice? (2) Is a training program for PrEP feasible for healthcare providers, measured by intention to continue applying the recommendations after the study conclusion? And (3) What is the anticipated effectiveness of a training program at increasing the proportion of PrEP-eligible GBM and TGNC who start PrEP within one month of a counseling session with a healthcare provider, compared to passive referral to existing resources?
In this open-label cluster randomized pilot trial, the investigators will randomize consenting providers to undergo an online self-paced training on brief user-centered PrEP counseling vs only receiving a list of available resources. The goal is to enroll a range of different healthcare provider types working in both urban and suburban settings, and in different work settings. Recruitment of user-participants will be facilitated by participating providers, but done by a research coordinator.
Randomization and inclusion of provider-participants is expected to start in October 2024 and will continue through February 2025. Data collection (questionnaires and interviews) will continue beyond that period for provider-participants, as well as for user-participants whose enrolment occurs during the specified recruitment dates.
The qualitative component will explore implementation considerations from the perspective of provider-participants. The investigators will do focus groups (of approximately one hour, variable size) and offer the possibility of doing individuals interviews (of approximately 30-45 minutes) if they cannot attend the focus groups.
In the analysis stage, counts and proportions will be used to describe categorical and dichotomous variables. Mean and standard deviations or median and interquartile range will be used to describe continuous normally and non-normally distributed variables respectively. For the anticipated effectiveness outcome, the intra-cluster correlation coefficient (ICC) among patient-participants will be calculated. For that purpose, our analysis will be a generalized linear mixed model (GLMM) with logit link to estimate the effect of using the training program on the probability of user-participants starting (or re-starting) PrEP, while accounting for clustering of user-participants within the respective providers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized pilot trial: healthcare providers will be randomized to either of the two arms and their clients; will then answer questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Online training about counseling GBM about HIV prevention with a focus on PrEP | Active comparator | Behavioral: Counseling, Other: List of resourcesThe intervention at the user level will consist of brief counseling by the participating provider about PrEP and tailored linkage to available information resources or services. This will be delivered through healthcare providers in the intervention arm, who would have completed a 60-minute online training designed by the research team. The intervention consists of using a theory-informed approach to user-centered brief counselling about PrEP uptake, designed specifically to help busy front-line providers in public health, sexual health and primary care settings advance clients along the PrEP cascade (specifically, supporting clients who meet evidence-based criteria for PrEP in accepting provider recommendations to use it) and provide linkage to care for related conditions. |
| Care as usual | Other | Other: List of resourcesCare as usual plus a list of available community resources related to HIV prevention and/or sexual health relevant to GBM |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CounselingThe intervention consists of using a theory-informed approach to user-centered brief counselling about PrEP uptake, designed specifically to help busy front-line providers in public health, sexual health and primary care settings advance clients along the PrEP cascade (specifically, supporting clients who meet evidence-based criteria for PrEP in accepting provider recommendations to use it) and provide linkage to care for related conditions. The intervention will be delivered to GBM through participating healthcare providers who would have completed an online training designed by the research team. | Behavioural | Online training about counseling GBM about HIV prevention with a focus on PrEP |
| List of resourcesThis list includes webpages which contain generic information about GBMs sexual health, PrEP, mental health, information about province-wide info lines for the general public about sexual health and/or educational resources for providers. | Other | Care as usual, Online training about counseling GBM about HIV prevention with a focus on PrEP |
Primary outcome
Acceptability
Time frame: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained using qualitative interviews (to take place within a month after the 3-month follow up)
Proportion of provider-participants who indicate they believe using the recommendations of the training program is no different, somewhat better or significantly better than their current practice, measured with a Likert scale.
5 secondary outcomes
Feasibility - trialability
Time frame: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained from of qualitative interviews, which will take place within one month after the 3-month follow up.
Feasibility - complexity
Time frame: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained from of qualitative interviews, which will take place within one month after the 3-month follow up.
Feasibility - recruitment
Time frame: Measured at baseline
Feasibility - retention
Time frame: At the 3-month follow up of participating healthcare providers
Anticipated effectiveness
Time frame: At the patient level, after each counseling session and at the 1 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Current projects at Options LabLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will be stored at St. Michael\'s hospital, a research and teaching site which hosts trainees at different levels working in various research projects. Data collected in this study will be used to support various research activities (abstracts, publications, presentations) by the research team and future trainees.
Related trials for Pre-Exposure Prophylaxis (PrEP)
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
HIV Infections
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.
Oscar Javier Pico Espinosa, MD MSPH PHD contact
Darrell H.S. Tan, MD, FRCPC, PHD principal investigator
St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling and List of resources in people with Pre-Exposure Prophylaxis (PrEP) and Counseling, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar Javier Pico Espinosa, MD MSPH PHD (416-864-6060 ext. 77476, oscarjavier.picoespinosa@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: At the 3-month follow up of participating healthcare providers. Contextual information will be obtained using qualitative interviews (to take place within a month after the 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 29 Nov 2024.