Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 495
- Locations
- 34
- Primary Endpoint
- Sexually Transmitted Infections risk score in men HIV positive
Study Overview
Brief Summary
Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.
Detailed Description
Main objectives are :
create and validate a risk score for STIs (DRIVER score) in a population of HIV-positive men who have sex with men (MSM).
determine the prevalence of asymptomatic STIs in a population of HIV-positive MSM
Secondary objectives are :
compare 2 screening strategies regarding STIs in HIV-positive MSM (systematic screening vs screening according to self-declared risk factors) conduct a cost-efficiency analysis of both strategies evaluate patients' knowledge of STIs develop a DRIVER digital tool that will be made available to patients on websites, mobile apps...
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV positive outpatients
- •Men who have sex with men
- •Speaking, literate french
- •Having a french health insurance or an equivalent
- •Asymptomatic for a STI the appointment day
Exclusion Criteria
- •Men who never had sex with men
- •Protected adults (adults under guardianship)
- •Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)
Outcomes
Primary Outcomes
Sexually Transmitted Infections risk score in men HIV positive
Time Frame: 6 months
Construction of a STI risk score
Secondary Outcomes
- prevalence of asymptomatic STIs in a population of HIV-positive MSM(6 months)
- cost-efficacy of a targeted screening versus universal screening(12 months)
- patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)(3 months)