Counseling for HIV Prevention

Overseen By Katherine Griffin, Program manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Darrell H.S. Tan, MD, FRCPC, PHD

Principal Investigator

St. Michael's Hospital

Eligibility Criteria

This trial is for healthcare providers in Ontario, Canada who work with gay, bisexual, and other men who have sex with men (GBM). Providers will either take a short online training about HIV prevention counseling or continue their usual care. GBM receiving counseling may also participate by completing questionnaires.

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

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)

For practicing health-care professionals, hold a valid license to practice in Ontario (this includes resident physicians)

Exclusion Criteria

Anticipate to stop working at their current practice site before the end of the study

Not being able to communicate in English

I have not previously declined to participate in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Healthcare providers undergo a 60-minute online training on user-centered PrEP counseling

1 week

Online module

Counseling and Data Collection

Healthcare providers conduct counseling sessions with GBM, and data is collected through questionnaires and interviews

4 months

Multiple sessions as needed

Follow-up

Participants are monitored for acceptability, feasibility, and effectiveness of the training program

3 months

Interviews and questionnaires

Treatment Details

Interventions

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

Trial Overview The study tests the effectiveness of an online guide designed to help healthcare providers counsel GBM on HIV prevention using PrEP. It compares outcomes from those who receive the training against those continuing standard practices.

Participant Groups

Group I: Care as usual Experimental Treatment 1 Intervention

Care as usual plus a list of available community resources related to HIV prevention and/or sexual health relevant to GBM

Group II: Online training about counseling GBM about HIV prevention with a focus on PrEP Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+