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Strengthening, Guidance, Health, Empowerment

Renforcement, Orientation, Santé, Empowerment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07788599
Acronym
ROSE
Enrollment
200
Registered
2026-08-26
Start date
2026-09-01
Completion date
2027-12-01
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Infection, Gonorrhea Infection, Hepatitis B, Hepatitis C, HIV Infection, Syphilis

Keywords

Screening, Self-sampling, Access to healthcare, Sex workers

Brief 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.

Interventions

OTHERSelf-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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER
CeGIDD - Free Information, Screening and Diagnosis Centre of Montpellier University Hospital
CollaboratorUNKNOWN
Médecins du Monde (ROSELA Programme)
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Care cascade following home self-sampling for STI screeningFrom study inclusion until completion of the care cascade, up to 3 months after inclusionThe 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

Secondary

MeasureTime frameDescription
Reasons for refusal of the kitAt InclusionReasons given by participants who refuse to use the kit.
Sociodemographic and clinical characteristics of the study populationAt inclusionDescription of the sociodemographic and clinical characteristics of the people included in the study
Screening for at least one of the six STIs before and during the interventionAt inclusion and through study completion, up to 3 months after inclusionA 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.
Screening for each of the six STIs before and during the interventionAt inclusion and through study completion, up to 3 months after inclusionA 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.
Number of outreach activitiesThroughout the 1-year enrollment periodNumber of physical and virtual outreach activities conducted by the ROSELA programme of Médecins du Monde during the study period
Number of people involved in outreach activitiesThroughout the 1-year enrollment periodNumber of people involved in conducting the physical and virtual outreach activities during the study period
Prevalence of the six sexually transmitted infectionsUp to 3 months after study inclusionPrevalence 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

Countries

France

Contacts

CONTACTHélène DONNADIEU, MD
h-donnadieu@chu-montpellier.fr00 33 4 67 33 70 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026