CClinicalTrials.gg
Active, not recruitingNCT05690815Express-PrEPUpdated Mar 29, 2024

Express Testing and Same-day Initiation of PrEP Study

An observational study in HIV Prevention, sponsored by HQ Toronto. Active, not recruiting at 1 site in Canada. Open to participants aged 16 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-29.

Sponsored by HQ Toronto · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
816
Ages
16 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Prevention

Keywords

  • PrEP
  • HIV
03

In context

Lead sponsor

This is the only study on the registry with HQ Toronto as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
816 participants (estimated)
Patient registry
No

Groups and cohorts

  • gbMSM

    This study will enroll gay, bisexual men who have sex with men (gbMSM), transgender and gender non-binary participants.

    Drug: Descovy

Interventions

  • DrugDescovy

    Descovy is a once-daily prescription medicine for adults and adolescents at risk of HIV. It helps lower the chances of getting HIV through sex. In this study, patients at risk of acquiring HIV will be screened for HIV and those that are HIV-negative will be initiated on PrEP within 24 hours.

    Also known as: emtricitabine 200 mg/tenofovir alafenamide 25 mg

06

What researchers measure

Primary outcomes

  1. Uptake of PrEP in a rapid, same day treatment initiation setting.

    The primary objective is to assess PrEP uptake in a rapid, same day treatment initiation setting. This includes proportion of those eligible for PrEP that initiate treatment on the same day as testing. All persons will be offered express laboratory testing onsite, which will greatly improve the time for PrEP initiation. Those people who test negative for HIV, and are eligible for PrEP based on a risk score, will be offered PrEP same day. The investigators expect that same day initiation for PrEP will improve PrEP uptake.

    Time frame: January 2023 to January 2024

Secondary outcomes

  1. Uptake of PrEP among key groups

    The secondary objective is to measure PrEP uptake among key risk groups. HQ provides target testing programs for high risk people, including Black and Latinx gbMSM, transgender and gender non-binary individuals, as well as those who experience mental health concerns and use substances. The study will assess if same-day initiation for key groups will prevent loss to follow up and will enable higher PrEP uptake among stigmatized and marginalized communities.

    Time frame: January 2023 to January 2024

07

Study locations

1 site
  • HQ Toronto
    Toronto, Ontario M5G 1N8, Canada
08

References and documents

Individual participant data

Plan to share: Undecided — There are not any current plans to share individual patient data with researchers in other institutions. If this were to take place, the data would be fully anonymized and proper data sharing agreements would be put in place.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05690815
Lead sponsor
HQ Toronto
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Jan 19, 2023
Start date
Jan 24, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Mar 29, 2024

Study contacts

Kevin S Woodward, MD
principal investigator · HQ Health HubToronto

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion