Express Testing and Same-day Initiation of PrEP Study

NCT05690815 | Active Not Recruiting FDA Drug

• 1 other identifier: IN-CA-412-6433
• Study Type: observational
• Target: 816
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Keywords

PrEP; HIV

Outcome Measures

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.

  January 2023 to January 2024

Secondary Outcomes (1)

• Uptake of PrEP among key groups

  January 2023 to January 2024

Study Arms (1)

gbMSM

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

Drug: Descovy

Interventions

Descovy DRUG

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

gbMSM

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• HQ Toronto: lead
• Gilead Sciences: collaborator

Study Sites (1)

HQ Toronto

Toronto, Ontario, M5G 1N8, Canada

Location

MeSH Terms

Interventions

emtricitabine tenofovir alafenamide; Emtricitabine; tenofovir alafenamide

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Kevin S Woodward, MD

  HQ Health HubToronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 24, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

CA (1)