Clinical trial NCT06710171: Filling Gaps in the HIV Pre-exposure Prophylaxis Cascade Through Counseling
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 \&amp;gt; 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 \&amp;gt; 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 outcomes:
measure: Acceptability
timeFrame: 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:
measure: Feasibility - trialability
timeFrame: 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.
measure: Feasibility - complexity
timeFrame: 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.
measure: Feasibility - recruitment
timeFrame: Measured at baseline
measure: Feasibility - retention
timeFrame: At the 3-month follow up of participating healthcare providers
measure: Anticipated effectiveness
timeFrame: At the patient level, after each counseling session and at the 1 month follow up
Other outcomes:
measure: Cost
timeFrame: Immediately after the completion of the online training and at the 3-month follow up of participating healthcare providers
measure: Appropriateness
timeFrame: At the 3-month follow up of participating healthcare providers
measure: Fidelity
timeFrame: At baseline and after one month
measure: Accepting a referral to a PrEP provider
timeFrame: At the patient level, after each counseling session (within 5 days) and at the 1 month follow up
measure: Willingness to start PrEP
timeFrame: At the patient level, after each counseling session (within 5 days) and at the 1 month follow up
measure: Perceived impact
timeFrame: At the 3-month follow up of participating healthcare providers
measure: Satisfaction
timeFrame: At the patient level, after each counseling session (within 5 days) and at the 1 month follow up
Locations:
city: Toronto
country: Canada
facility: Options Lab
state: Ontario
Study officials:
affiliation: St. Michael&#39;s Hospital
name: Darrell H.S. Tan, MD, FRCPC, PHD
role: PRINCIPAL_INVESTIGATOR
References: