Clinical trial NCT05690815: Express Testing and Same-day Initiation of PrEP Study
Official title: Express Testing and Same-day Initiation of PrEP
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Prevention
Keywords: PrEP
HIV
Lead sponsor: HQ Toronto
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2023-01-19
Enrollment: 816
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is targeting gay, bisexual men who have sex with men, transgender, and gender non-binary individuals

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Patients 16 years of age and older, visiting HQ for express testing, HIV negative and not currently on PrEP.

Exclusion criteria: Patients under the age of 16 years of age, currently on PrEP, or living with HIV.

Primary outcomes:
measure: Uptake of PrEP in a rapid, same day treatment initiation setting.
timeFrame: January 2023 to January 2024
Secondary outcomes:
measure: Uptake of PrEP among key groups
timeFrame: January 2023 to January 2024
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: HQ Toronto
state: Ontario
Study officials:
affiliation: HQ Health HubToronto
name: Kevin S Woodward, MD
role: PRINCIPAL_INVESTIGATOR
References: