Chlamydia Trachomatis Infection Clinical Trial
— GonoScreenOfficial title:
Does Screening for Gonorrhea and Chlamydia Affect the Incidence of These Infections in Men Who Have Sex With Men Taking HIV Pre Exposure Prophylaxis (PrEP): a Randomized, Multicentre Controlled Trial
Verified date | September 2022 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention).
Status | Completed |
Enrollment | 1014 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Able and willing to provide informed consent - Men (born as males) and transwomen aged 18 or more - Has had sex** with another man in the last 12 months - Enrolled in Belgian PrEP program at ITM/HSP/EH/CHU/UZG with approval for TDF/FTC (Tenofovir disoproxil fumarate/Emtricitabine) reimbursement from a Belgian Medical Aid - Willing to comply with the study procedures and to attend the clinic for the 3-monthly visits Exclusion Criteria: - Enrolment in another interventional trial - Tests HIV-positive at screening - Symptoms of proctitis or urethritis |
Country | Name | City | State |
---|---|---|---|
Belgium | Institute of Tropical Medicine | Antwerp | |
Belgium | CHU Saint-Pierre | Brussels | |
Belgium | Hôpital Erasme | Brussels | |
Belgium | UZGent | Gent | |
Belgium | CHU Liège | Liège |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Ng plus Ct detected at any site whilst individuals are screened vs. not screened | number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits. | 12 months | |
Secondary | Cumulative antimicrobial exposure (ceftriaxone/azithromycin/doxycycline) | number of standard doses per 1000 person-years | 12 months | |
Secondary | Incidence of symptomatic Ng plus Ct | 12 months | ||
Secondary | Incidence of syphilis | 12 months | ||
Secondary | Incidence of HIV | 12 months | ||
Secondary | Economic impact of cessation of 3x3 screening in MSM in Belgium | amount of costs relating to laboratory testing, price of antimicrobial therapy and administration and costs of consultations from standard sources such as Rijksinstituut voor ziekte- en invaliditeitsverzekering/Institut national d'assurance maladie-invalidité (RIZIV/INAMI) reimbursement schema and Belgisch Centrum voor Farmacotherapeutische Informatie (BCFI). | 12 months | |
Secondary | Questionnaire to assess the variations in PrEP users' perceptions towards STI screening | questions to enhance discussion on sexual health, STI prevention and the role of screening for STIs. | 12 months |
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