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Clinical Trials in Canada / NCT06710171
Starting soon Not applicable

Filling Gaps in the HIV Pre-exposure Prophylaxis Cascade Through Counseling

NCT06710171 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-01
Last updated
2024-11-29

Condition(s) studied

Pre-Exposure Prophylaxis (PrEP)CounselingSexual and Gender Minorities

Investigational drug(s) / intervention(s)

CounselingList of resources

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.

Study 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.

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Options Lab Toronto Ontario

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06710171 on ClinicalTrials.gov ↗ ← All trials in Canada