Filling Gaps in the HIV Pre-exposure Prophylaxis Cascade Through Counseling
NCT ID: NCT06710171
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-01-31
2025-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Online training about counseling GBM about HIV prevention with a focus on PrEP
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.
Counseling
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 resources
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.
Care as usual
Care as usual plus a list of available community resources related to HIV prevention and/or sexual health relevant to GBM
List of resources
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.
Interventions
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Counseling
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 resources
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.
Eligibility Criteria
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Inclusion Criteria
* Anticipate encountering a minimum of five PrEP-eligible GBM and TGNC eligible for PrEP in the three months after enrolling in the study
* 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).
Exclusion Criteria
* 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
19 Years
ALL
Yes
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Darrell H.S. Tan, MD, FRCPC, PHD
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital
Locations
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Options Lab
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Katherine Griffin, Manager
Role: primary
Darrell H.S. Tan, MD, FRCPC, PHD
Role: backup
Related Links
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Current projects at Options Lab
Other Identifiers
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EFP-1129-BNG
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23-177
Identifier Type: -
Identifier Source: org_study_id