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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and user-friendliness of a new guide for healthcare providers counseling on HIV prevention, with a focus on PrEP (a medication that helps prevent HIV in HIV-negative individuals). The study involves healthcare providers, such as doctors and nurses, who treat gay, bisexual, and other men who have sex with men (GBM). Providers will either undergo online training on PrEP counseling or continue their usual practices. Suitable candidates for participation are GBM who have recently engaged in condomless anal sex and have certain health conditions or sexual health histories. Conducted in Ontario, Canada, the trial will collect feedback from both providers and their patients through questionnaires. As an unphased trial, this study allows participants to contribute to innovative HIV prevention strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on counseling for HIV prevention and does not mention any medication restrictions.

What prior data suggests that this counseling method is safe for healthcare providers and GBM?

Research shows that PrEP (pre-exposure prophylaxis) is generally easy for people to take without issues. PrEP is a medicine used by individuals who do not have HIV to help prevent infection. Studies have found that people taking PrEP often experience few side effects, which are usually mild. Common side effects include nausea, headaches, and fatigue, but these often subside over time.

This study focuses on training healthcare providers to discuss PrEP, rather than on the medication itself. The training is an online course for providers and does not present safety concerns like a medication might. The goal is to equip providers to discuss PrEP with their patients and support them if they choose to use it.

There is no specific data about safety issues with this training because it is an educational program, not a drug trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to HIV prevention counseling, specifically designed to enhance the uptake of PrEP (pre-exposure prophylaxis) among gay and bisexual men (GBM). Unlike traditional HIV prevention methods that may not always effectively engage patients, this trial focuses on training healthcare providers to deliver brief, targeted counseling sessions. These sessions use a theory-informed, user-centered approach to guide clients through the PrEP cascade, linking them to necessary care and resources. By improving communication and support from healthcare providers, this method aims to make HIV prevention more accessible and effective for those at higher risk.

What evidence suggests that this counseling method is effective for HIV prevention?

Research has shown that counseling can significantly increase the use of PrEP, a medication that prevents HIV infection. This trial will compare two approaches: one group will receive online training on counseling gay and bisexual men (GBM) about HIV prevention with a focus on PrEP, while the other group will receive standard care. Studies have found that improving the PrEP care process can reduce new HIV cases among men who have sex with men. Effective counseling about PrEP from healthcare providers helps overcome obstacles to starting and continuing the medication. Evidence also indicates that better counseling leads to more people beginning and staying on PrEP, which is essential for preventing new HIV infections. Therefore, counseling is a key step in enhancing HIV prevention efforts. ^{1 2 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

St. Michael's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06710171

Filling Gaps in the HIV Pre-exposure Prophylaxis Cascade ... This study s objective is to test the acceptability and feasibility of a guide to facilitate counseling about HIV prevention, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6438815/

Addressing Gaps in HIV Preexposure Prophylaxis Care to ... In this modeling study, we found that implementation of PrEP could reduce absolute disparities in HIV incidence between BMSM and WMSM even despite current ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352301819304333

Uptake, engagement, and adherence to pre-exposure ... We aimed to assess PrEP uptake and engagement after population-level HIV testing and universal PrEP access to characterise gaps in the PrEP cascade in rural ...

4. ghspjournal.org ghspjournal.org/content/12/2/e2300229

Applying a Three-Tier Approach to Address Gaps in Oral ... We describe a 3-tier approach involving a gap analysis, root cause analysis, and pre-exposure prophylaxis (PrEP) collaborative to understand the gap and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5315535/

Uptake of HIV pre-exposure prophylaxis (PrEP) in a ... Intervention efforts have been directed towards closing “gaps” in the HIV care cascade. Meaningful progress has been made, but more than 14% of HIV-positive ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S277306542500121X

HIV Pre-Exposure Prophylaxis Care Continuum in ... The 34 studies were comprised of 71,162 individuals eligible for PrEP. Among them, 66% had increased HIV risk awareness, 55% had enhanced PrEP ...

7. publichealth.jmir.org publichealth.jmir.org/2024/1/e65713

HIV Pre-Exposure Prophylaxis Cascade Stages Among Men ... This study's objective was to explore the HIV PrEP cascade stages (knowledge, willingness to use, and use) among MSM with STIs in China

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527664/

DETERMINANTS OF PRE-EXPOSURE PROPHYLAXIS ... To understand gaps in the uptake of oral daily PrEP, we categorized the HIV PrEP cascade as (i) education about PrEP, (ii) interest in PrEP, (iii) successful ...