About The Study

The enhanced syphilis screening among HIV-positive men (ESSAHM) trial will assess the feasibility, usefulness, and cost-effectiveness of improving syphilis screening among HIV-positive men by introducing syphilis screening as a part of regular HIV testing. This trial is the first of its kind in Canada and knowledge gained during the study may be applicable to other sexually transmitted and blood-borne infections in men living with HIV like chlamydia, gonorrhea, and viral hepatitis.

About The Disease

Syphilis is a growing health concern among men who have sex with men (MSM) in Canada and around the world. Bacteria that are transmitted through oral, vaginal, or anal sexual activity cause the infection. Syphillis treatment may be less successful and transmission rates and symptoms of syphilis infection may be more serious in HIV-positive men than in HIV-negative men. Furthermore, both the risk of transmitting and acquiring HIV may be greater for people with syphilis infection. Between 2002 and 2014, 99.9% of HIV-syphilis co-infection in Ontario were in males. No new cases of syphilis among women with HIV have been reported in the province of Ontario.

Study Approach

Four urban HIV clinics in Ontario are involved in the ESSAHM trial. At each clinic, men will receive routine syphilis testing whenever they receive scheduled HIV blood tests. Men attending the clinics can decline syphilis testing or ask for their data not to be used at any point during the trial. The study will measure if the introduction of routine testing changes the rates of detection for new, untreated syphilis cases. Other measures of screening coverage and frequency will also be compared.

The study design used in this trial is a stepped wedge cluster-randomized controlled design. The study will begin with a 6-month baseline period to find out the current rate of syphilis detection. The clinics will then be randomized to one of four schedules to begin the testing intervention, one after another, each 6 months apart.

If you would like more information on this clinical study, please refer to clinicaltrials.gov.

Eligibility Requirements

Required

Although the current syphilis outbreak is concentrated mainly in MSM, the study is open to all men receiving syphilis care at the participating clinics. This is done to avoid the need for disclosure of sexual status at the time of testing and to simplify the logistics of the study.

Inclusion Criteria:

  • Male living with HIV
  • Must be attending at least one of the four participating hospital-based HIV outpatient clinics

Not Allowed

  • Women

Additional Information

If you would like more information on this clinical study, please refer to clinicaltrials.gov.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Dr. Ann Burchell

Co-Leader, Co-infections and Related Conditions Core; Member, Steering Committee

St. Michael’s Hospital

View Bio

Participating Sites

Here’s where this study is being conducted.