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

NCT06710171 | Not Yet Recruiting

• 2 other identifiers: 23-177EFP-1129-BNG
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Exposure Prophylaxis (PrEP); Counseling; Sexual and Gender Minorities

Keywords

gay; men who have sex with men; bisexual; HIV PrEP; Pre-exposure prophylaxis; primary care; counseling; pilot trial; HIV prevention; sexual health

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Measured at baseline

• Feasibility - retention

  At the 3-month follow up of participating healthcare providers

• Anticipated effectiveness

  At the patient level, after each counseling session and at the 1 month follow up

Other Outcomes (7)

• Cost

  Immediately after the completion of the online training and at the 3-month follow up of participating healthcare providers

• Appropriateness

  At the 3-month follow up of participating healthcare providers

• Fidelity

  At baseline and after one month

Study Arms (2)

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.

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

Other: List of resources

Interventions

Counseling BEHAVIORAL

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.

Online training about counseling GBM about HIV prevention with a focus on PrEP

List of resources OTHER

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; Online training about counseling GBM about HIV prevention with a focus on PrEP

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: All genders different from cisgender woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anticipate to stop working at their current practice site before the end of 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).
• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Options Lab

Toronto, Ontario, M5B 1T8, Canada

Location

Related Links

• Current projects at Options Lab

MeSH Terms

Conditions

Coitus; Homosexuality; Bisexuality

Interventions

Counseling

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Sexuality

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Darrell H.S. Tan, MD, FRCPC, PHD

  St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Javier Pico Espinosa, MD MSPH PHD

CONTACT

416-864-6060; oscarjavier.picoespinosa@unityhealth.to

Katherine Griffin, Program manager

CONTACT

416-864-6060; katherine.griffin@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: November 29, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)