An interventional study of Self-sampling for six sexually transmitted infections in HIV Infection, Syphilis and Gonorrhea Infection, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Screening
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:
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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.
Care cascade following home self-sampling for STI screening
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
Time frame: From study inclusion until completion of the care cascade, up to 3 months after inclusion
Reasons for refusal of the kit
Reasons given by participants who refuse to use the kit.
Time frame: At Inclusion
Sociodemographic and clinical characteristics of the study population
Description of the sociodemographic and clinical characteristics of the people included in the study
Time frame: At inclusion
Screening for at least one of the six STIs before and during the intervention
A study questionnaire will be used at inclusion to collect self-reported information on STI screening during the 6 months preceding questionnaire completion. Participants will be asked whether they have undergone screening for at least one of the six sexually transmitted infections (HIV, hepatitis B, hepatitis C, syphilis, chlamydia and gonorrhoea) during this period. The proportion of participants reporting at least one STI screening during the previous 6 months will be compared with the proportion of participants who undergo screening for at least one of the six STIs during the intervention.
Time frame: At inclusion and through study completion, up to 3 months after inclusion
Screening for each of the six STIs before and during the intervention
A study questionnaire will be used to collect self-reported information on STI screening during the 6 months preceding questionnaire completion. For each of the six sexually transmitted infections (HIV, hepatitis B, hepatitis C, syphilis, chlamydia and gonorrhoea), participants will be asked whether they have undergone screening during this period. For each STI, the proportion of participants reporting screening during the previous 6 months will be compared with the proportion of participants who undergo screening for the corresponding STI during the intervention.
Time frame: At inclusion and through study completion, up to 3 months after inclusion
Number of outreach activities
Number of physical and virtual outreach activities conducted by the ROSELA programme of Médecins du Monde during the study period
Time frame: Throughout the 1-year enrollment period
Number of people involved in outreach activities
Number of people involved in conducting the physical and virtual outreach activities during the study period
Time frame: Throughout the 1-year enrollment period
Prevalence of the six sexually transmitted infections
Prevalence of HIV, hepatitis B, hepatitis C, syphilis, chlamydia and gonorrhoea among sex workers encountered during the physical and virtual outreach activities conducted by Médecins du Monde. Prevalence will also be analysed by subgroup according to men who have sex with men (MSM) and non-MSM status
Time frame: Up to 3 months after study inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →