Strengthening, Guidance, Health, Empowerment

Sponsor
University Hospital, Montpellier
Study ID
NCT07788599
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Self-sampling for six sexually transmitted infections — OTHER
    Participants will complete a questionnaire, with the assistance of the investigator, collecting sociodemographic information and information related to their sex work activity. They will then be offered a pre-labelled self-sampling kit containing: 1- a three-site sampling test for chlamydia and gonorrhoea; 2- a dried blood spot (DBS) card for self-collection of blood samples which will be analysed for HIV, hepatitis B, hepatitis C and syphilis. Participants may decline the kit. They will perform the sampling independently at home or at a place of their choice. Samples will be returned by post to the virology / bacteriology laboratories or handed to the ROSELA team during a physical outreach activity. Pseudonymised results will be made available to the CeGIDD of Montpellier and communicated to participants according to their preferred method. In case of a positive result, appropriate medical care, including further investigations and treatment, where required, will be offered.

Study Details

The goal of this interventional study is to describe the care pathway following the use of an innovative home self-sampling method for the screening of six sexually transmitted infections (STIs) among sex workers met during physical or virtual outreach activities conducted by the ROSELA programme of Médecins du Monde in Montpellier and the surrounding area. The main questions it aims to answer are: * How many people are offered STI self-sampling, receive a self-sampling kit, and return the collected samples for laboratory testing * What proportion of participants are recontacted and attend a consultation following the screening results Participants will receive a self-sampling kit allowing them to collect samples at home or at a place of their choice and complete a questionnaire covering socio-demographic information and information related to their sex work activity.

Key Dates

First listed
Aug 26, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: Self-sampling group
    Participants are sex workers encountered during physical or virtual outreach activities conducted by the ROSELA programme of Médecins du Monde in Montpellier and the surrounding area. They will complete a study questionnaire and will be offered the self-sampling kit.

Primary Outcome Measure

Care cascade following home self-sampling for STI screening [ Time Frame: From study inclusion until completion of the care cascade, up to 3 months after inclusion ]

Central Contacts

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