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Starting soon Not applicable

Strengthening, Guidance, Health, Empowerment

NCT07788599 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-08-26

Condition(s) studied

HIV InfectionSyphilisGonorrhea InfectionChlamydia InfectionHepatitis BHepatitis C

Investigational drug(s) / intervention(s)

Self-sampling for six sexually transmitted infections

Self-sampling for six sexually transmitted infections: 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 summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Being a sex worker or identifying as a sex worker * Being an adult (18 years or older) * Providing free and informed consent to participate in the study Exclusion Criteria: * Inability to understand the study * Being under guardianship, curatorship or a future protection mandate * Participation in another research study with an exclusion period that is still ongoing at the time of pre-inclusion

Primary outcome measure(s)

  • Care cascade following home self-sampling for STI screening — From study inclusion until completion of the care cascade, up to 3 months after inclusion
    The care cascade will be assessed through the following steps: 1. \- number of people offered the self-sampling test 2. \- percentage of people who receive a self-sampling kit among those offered the test 3. \- percentage of people who return the self-sampling kit to the laboratory or hand it to the ROSELA team among those who received a kit 4. \- percentage of people who are successfully recontacted among those who returned the kit to the laboratory 5. \- percentage of people who attend a consultation among those who are recontacted and offered an appointment

Trial sites (1)

FacilityCityRegionStatus
ROSELA _ Médecins du Monde Montpellier Hérault
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07788599 on ClinicalTrials.gov ↗ ← All trials in France