Strengthening, Guidance, Health, Empowerment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Self-sampling for six sexually transmitted infections
Other interventionParticipants 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Self-sampling groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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 inclusionSecondary outcomes
1
Reasons for refusal of the kit
Reasons given by participants who refuse to use the kit.
Time frame
At Inclusion2
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 inclusion3
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 inclusion4
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 inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
CeGIDD - Free Information, Screening and Diagnosis Centre of Montpellier University Hospital
Collaborator
Médecins du Monde (ROSELA Programme)
Collaborator
Source ClinicalTrials.gov
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