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

Filling Gaps in the PrEP Cascade: User-centered Counseling About HIV Pre-exposure Prophylaxis and Linkage to Care for Gay, Bisexual and Other Men Who Have Sex with Men

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Counseling; Sexual and Gender Minorities; Pre-Exposure Prophylaxis (PrEP)
• Intervention / Treatment: Behavioral: Counseling; Other: List of resources

Detailed Description

Our research questions are: (1) Is a training program for PrEP acceptable for healthcare providers, measured by perceived advantage of applying the recommendations learned in the program, compared to current practice? (2) Is a training program for PrEP feasible for healthcare providers, measured by intention to continue applying the recommendations after the study conclusion? And (3) What is the anticipated effectiveness of a training program at increasing the proportion of PrEP-eligible GBM and TGNC who start PrEP within one month of a counseling session with a healthcare provider, compared to passive referral to existing resources?

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oscar Javier Pico Espinosa, MD MSPH PHD; Phone Number: 77476 416-864-6060; Email: oscarjavier.picoespinosa@unityhealth.to
• Study Contact Backup: Name: Katherine Griffin, Program manager; Phone Number: 77476 416-864-6060; Email: katherine.griffin@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1T8
      • Options Lab
      • Contact: Katherine Griffin, Manager; Phone Number: 77476 416-864-6060; Email: katherine.griffin@unityhealth.to
      • Contact: Darrell H.S. Tan, MD, FRCPC, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.; Other: 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.
Other: Care as usual; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - trialability	Proportion of provider-participants who indicate they are somewhat likely or very likely to use the recommendations of the training program in the future, measured with a Likert scale	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	Ease of use of the training package (using a Likert scale). Answering somewhat easy or very easy.	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	Number of providers consenting to participate during the planned enrollment period (October to January)	Measured at baseline
Feasibility - retention	Proportion of provider-participants retained in the study after three months, out of provider-participants who start the training	At the 3-month follow up of participating healthcare providers
Anticipated effectiveness	Proportion of user-participants who start (or re-start) PrEP within one month after the initial encounter	At the patient level, after each counseling session and at the 1 month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost	Additional time per patient needed to apply the intervention (numeric, in minutes)	Immediately after the completion of the online training and at the 3-month follow up of participating healthcare providers
Appropriateness	Alignment with values and culture of providers (4-point Likert scale): answering somewhat well or very well.	At the 3-month follow up of participating healthcare providers
Fidelity	Degree to which the intervention was used as intended.: Fidelity will be measured with (1) and (2); A checklist filled out by the provider-participant during the appointments.; Equivalent questions in the post-appointment questionnaire for user-participants. This list consists of: asking about values, addressing information gaps, talking about mental health and talking about the GBMs ability to obtain PrEP. The fidelity outcome will be measured by the proportion of providers indicating that they covered at least one of the topics/users indicating the providers discussed at least one of the recommended topics.	At baseline and after one month
Accepting a referral to a PrEP provider	Proportion of user-participants who accept a referral for PrEP	At the patient level, after each counseling session (within 5 days) and at the 1 month follow up
Willingness to start PrEP	Change in willingness to start (or re-start) PrEP (0-10 numeric rating scale) A positive difference of one unit or higher indicating increased willingness	At the patient level, after each counseling session (within 5 days) and at the 1 month follow up
Perceived impact	Perceived impact (in terms of increasing the proportion of users who start PrEP) of using the intervention (4-point Likert scale): answering somewhat positive; or significantly positive impact	At the 3-month follow up of participating healthcare providers
Satisfaction	User-participant satisfaction with the clinical encounter (5-point Likert scale) Measured by the proportion of GBM indicating they were satisfied or very satisfied	At the patient level, after each counseling session (within 5 days) and at the 1 month follow up

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Darrell H.S. Tan, MD, FRCPC, PHD, St. Michael's Hospital

Publications and helpful links

Helpful Links

• Current projects at Options Lab

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: counseling; primary care; HIV prevention; HIV PrEP; Pre-exposure prophylaxis; sexual health; men who have sex with men; pilot trial; bisexual; gay
• Other Study ID Numbers: 23-177; EFP-1129-BNG (Other Grant/Funding Number: The Ontario HIV Treatment Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be stored at St. Michael's hospital, a research and teaching site which hosts trainees at different levels working in various research projects. Data collected in this study will be used to support various research activities (abstracts, publications, presentations) by the research team and future trainees.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No