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POCT for Syphilis and HIV (SHIVER Trial)

N/A
Recruiting
Led By Stuart Skinner, MD
Research Sponsored by Wellness Wheel Medical Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-18 months
Awards & highlights

SHIVER Trial Summary

This trial will evaluate the performance of POCTs for syphilis & HIV in at-risk populations, and assess their acceptability & feasibility.

Who is the study for?
This trial is for individuals over 16 years old in Saskatchewan who are seeking testing for sexually transmitted and blood-borne infections (STBBIs). It's focused on those at risk or hard to reach, including people living with HIV or syphilis. Participants must be able to give informed consent, which means they understand the study and agree to participate.Check my eligibility
What is being tested?
The study tests how well finger prick blood point of care testing (POCT) works compared to standard serum-based tests for detecting syphilis and HIV. It looks at diagnostic accuracy, impact on treatment timing, exposure risk reduction, and connection speed to ongoing management for HIV.See study design
What are the potential side effects?
There may not be direct side effects from the POCT itself as it involves a simple finger prick test. However, discomfort or bruising at the puncture site can occur. The main focus is on evaluating test performance rather than medication-related side effects.

SHIVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Secondary outcome measures
Dual HIV/Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
Evaluate the acceptability and feasibility of POCT for syphilis and HIV
HIV-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
+5 more

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaOTHER
27 Previous Clinical Trials
3,868 Total Patients Enrolled
University of SaskatchewanOTHER
251 Previous Clinical Trials
152,760 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
40 Previous Clinical Trials
4,789 Total Patients Enrolled
1 Trials studying Syphilis
25 Patients Enrolled for Syphilis

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05863117 — N/A
Syphilis Research Study Groups:
Syphilis Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT05863117 — N/A
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05863117 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently being recruited for participation in this clinical trial?

"Clinicaltrials.gov reveals that this research study is currently seeking participants for enrollment, with the first posting on February 1st 2023 and last update occurring on May 8th of the same year."

Answered by AI

How many participants have been recruited into this research endeavor?

"Confirmed. Per clinicaltrials.gov, this research is still enrolling participants and was first shared on 2/1/2023 with a recent update on 5/8/2023. This trial requires 1650 patients to be enrolled across two medical centres."

Answered by AI

What goals has this clinical experiment set out to accomplish?

"The primary purpose of this medical research conducted over a one-year and a half period is to evaluate the efficacy of point of care testing for syphilis/HIV in contrast with serology testing. Subsequent objectives seek to ascertain the acceptability and feasibility among diverse patient demographics through an experience survey, as well as any preferences between HIV only tests, Syphilis only tests or dual testings (Syphilis & HIV)."

Answered by AI
~194 spots leftby Jul 2024