Filling Gaps in the HIV Pre-exposure Prophylaxis Cascade Through Counseling
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUnity Health Toronto
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Counseling
BehavioralThe 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.
List of resources
Other interventionThis 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Online training about counseling GBM about HIV prevention with a focus on PrEPActive comparator 2 interventions
Group B: Care as usualOther 1 intervention
Trial outcomes
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.
Time frame
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
1
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
Time frame
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.2
Feasibility - complexity
Ease of use of the training package (using a Likert scale). Answering somewhat easy or very easy.
Time frame
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.3
Feasibility - recruitment
Number of providers consenting to participate during the planned enrollment period (October to January)
Time frame
Measured at baseline4
Feasibility - retention
Proportion of provider-participants retained in the study after three months, out of provider-participants who start the training
Time frame
At the 3-month follow up of participating healthcare providersOther outcomes
1
Cost
Additional time per patient needed to apply the intervention (numeric, in minutes)
Time frame
Immediately after the completion of the online training and at the 3-month follow up of participating healthcare providers2
Appropriateness
Alignment with values and culture of providers (4-point Likert scale): answering somewhat well or very well.
Time frame
At the 3-month follow up of participating healthcare providers3
Fidelity
Degree to which the intervention was used as intended.: Fidelity will be measured with (1) and (2) 1. A checklist filled out by the provider-participant during the appointments. 2. 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.
Time frame
At baseline and after one month4
Accepting a referral to a PrEP provider
Proportion of user-participants who accept a referral for PrEP
Time frame
At the patient level, after each counseling session (within 5 days) and at the 1 month follow upSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: