Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05690815 |
| Other study ID # |
IN-CA-412-6433 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2023 |
| Est. completion date |
November 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
HQ Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is an observational cohort study to measure the impact of express testing and
same-day initiation of Pre-Exposure Prophylaxis (PrEP) on outcomes related to the PrEP
cascade. The investigators expect that same day initiation for PrEP will improve PrEP uptake.
The investigators hypothesize that baseline HIV test positivity will be higher than that of
general testing for gbMSM in Ontario. This is a key indicator to determine whether this
targeted approach is able to access the highest risk population.
Description:
Gay, bisexual men who have sex with men (gbMSM) account for over half of new HIV infections
in Canada each year, experience a disproportionately high burden of new HIV infections, and a
131-fold higher risk of HIV than other Canadian men. Transgender women (TGW) are a population
also at increased HIV risk and a priority for HIV prevention.
Pre-Exposure Prophylaxis (PrEP) for prevention of HIV infection using regular oral tenofovir
disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC)
is an effective and safe HIV prevention option for MSM and data from the Canadian setting
shows that awareness, interest and willingness to use PrEP have been rising in this
population. Accessing PrEP is currently a multistep process, often across several healthcare
settings, that creates unnecessary barriers leading to attrition or delays in initiation.
Although PrEP uptake has increased over time in Ontario, there is a significant proportion of
gbMSM who are not on PrEP that would benefit from initiation. In multiple studies of the PrEP
cascade, drop off in patient participation can be seen at each -level of the continuum often
as a result of delays in the accessibility of starting PrEP and the multiple steps required
by patients.
The success of PrEP has led to a decrease in HIV diagnoses among men in Ontario in recent
years, however, Black and Latinx gbMSM, and TGW make up a disproportionate percentage of
positive diagnoses. Despite recent increases in PrEP uptake, it is well understood that BIPOC
experience barriers when accessing PrEP, leading to lower rates of uptake compared to white
gbMSM. A critical component of the HIV care continuum in Ontario will be to increase the
uptake of testing and PrEP use within those populations experiencing disproportionate risk,
as well as people who experience mental health or substance use issues.
Currently in Ontario, the turnaround time between sample collection and a confirmatory
positive HIV test to the provider can be a week or more. The HQ lab is designed to conduct
laboratory HIV screening within 1 to 2 hours and confirmatory testing onsite in approximately
3 to 4 hours. This will allow the HQ team to offer same-day PrEP initiation for eligible
participants in less than 2 hours following a negative HIV screening test. No other clinical
program has been able to draw the blood sample, have both the screening and confirmatory
lab-based testing done, give the diagnosis, and initiate PrEP on the same day.
