Despite decades of traditional prevention efforts based on behavior change and condom use,
Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure
prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of
antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of
acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based
on medical and ethical grounds, and is supported by treatment guidelines. Yet several
implementation challenges have limited its clinical and public health impact in Ontario,
where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering
PEP for sexual exposures (nPEP). Results will inform the development of a standardized
approach to nPEP both province-wide and elsewhere.
Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial
design to determine whether the proportion of nPEP patients that successfully complete
follow-up:
1. is higher among those receiving mobile phone-based text messaging support than among
those receiving standard care; and
2. is non-inferior among those receiving care from a sexual health clinic nurse compared to
those receiving hospital-based physician care.
The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 318 study
participants in Toronto. In Intervention A, we will randomize half of study participants to a
text messaging support service ('WelTel'), in which a trained, community-based counselor
provides standardized weekly 'check-in' messages during their 12-week course of PEP
follow-up. The other half will receive standard care, which does not include any form of
active outreach or reminders outside of scheduled appointments. In Intervention B, we will
randomize half of participants to receive nurse-led care for PEP follow-up at a local sexual
health clinic; the other half will receive standard care by a hospital-based ID physician.
The specific activities for each follow-up visit will be clearly defined in a medical
directive. In keeping with Ontario legislation on medical directives, nurses will review
cases with their authorizing physician or nurse practitioner on a routine basis.
Phase:
Phase 2
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto
Collaborators:
Canadian Institutes of Health Research (CIHR) CIHR Canadian HIV Trials Network