About the study (objectives)
This study will determine the feasibility of two interventions that aim to change the way pre-exposure prophylaxis (PrEP) is delivered as a part of a combination HIV prevention approach. The first intervention will link family physicians to education material about PrEP while the second will implement nurse-led PrEP delivery in participating sexual health clinics.
About the disease/condition (background/context)
In February of 2016, Health Canada approved the use of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC – Truvadaâ) for daily use as a form of PrEP. Multiple clinical trials have shown that for gay, bisexual and other men who have sex with men (MSM) TDF/FTC can reduce the risk of HIV by up to 99%, if adherence is high.
Currently, PrEP is prescribed by a small number of specialist physicians who have experience in these medications. The use of and interest in PrEP is steadily rising and the upcoming release of generic TDF/FTC means that the cost of these medications will be significantly reduced. This increased demand will require a change in the way PrEP is delivered, not only to allow these specialists to care for those already living with HIV but also to allow equitable and consistent access.
To address this approaching increase in PrEP use, CTN 303 will assess the feasibility of decentralizing PrEP delivery to family physicians and sexual health clinic nurses by building capacity for these healthcare personnel to deliver PrEP.
Study Approach (methodology)
This study will assess two PrEP delivery interventions simultaneously. Both interventions begin with participant recruitment online and through community-based organizations. Participants will complete an online information module after being given a unique (numbered) PrEP postcard.
A) Dissemination Strategy: Patient-initiated Continuing Medical Education (CME)
In this portion, participants will bring the postcard to their family physician. The postcard contains information about HIV risk and the appropriateness of PrEP and will link the physician to an accredited continuing medical education (CME) physician module. This module will familiarize the physician with PrEP and allow him or her to feel comfortable about initiating PrEP in their patient, if appropriate.
B) Implementation Strategy: Nurse-led PrEP
For participants who do not have a family physician or are not comfortable approaching their physician, the postcard can be taken to a participating sexual health clinic. Participants will then be booked to see a trained nurse and begin PrEP, if appropriate. Nurses at these clinics will already have been trained using the same CME module as in the family physician arm.
Participant information, clinical outcomes, cost estimates, and focus group results will be collected to inform the success of these interventions.
CTN Postdoctoral Fellow, Dr. Malika Sharma, is leading the development, delivery, and assessment of the PICME module as a part of her fellowship project.
Participants for this study will be recruited through an existing network of 23 community-based organizations (CBOs) in Toronto. CBOs will be asked to identify participants meeting the following criteria:
- Gay, bisexual or other man who has sex with men
- Believed to be HIV-uninfected
- Interested in or appropriate for PrEP in the opinion of the CBO staff
- Resident in the Greater Toronto Area
If you would like more information on this clinical study, please refer to the principal investigator.
Dr. Darrell Tan
University Health Network