HIV InfectionROSENCT07788599
Strengthening, Guidance, Health, Empowerment
A study testing Self-sampling for six sexually transmitted infections in people with HIV Infection and Syphilis, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Syphilis, Gonorrhea Infection
- What is being tested?
- Self-sampling for six sexually transmitted infections
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
ROSELA _ Médecins du Monde
Montpellier, Hérault, 34 000
Victor DUPERRET, 00 33 7 58 81 77 37, victor.duperret@medecinsdumonde.net
Aziliz ALMY
About this study
Official title: Renforcement, Orientation, Santé, Empowerment
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.
- Conditions
- HIV Infection, Syphilis, Gonorrhea Infection, Chlamydia Infection, Hepatitis B, Hepatitis C
- Being tested
- Self-sampling for six sexually transmitted infections
- Keywords
- Screening, Self-sampling, Access to healthcare, Sex workers
- Medical subject headings
- HIV Infections, Syphilis, Chlamydia Infections, Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-sampling for six sexually transmitted infectionsOther
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 group | Role | What they receive |
|---|---|---|
| Self-sampling group | Other | 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. Receives: Other: Self-sampling for six sexually transmitted infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care cascade following home self-sampling for STI screening
The care cascade will be assessed through the following steps:
- - number of people offered the self-sampling test
- - percentage of people who receive a self-sampling kit among those offered the test
- - 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
- - percentage of people who are successfully recontacted among those who returned the kit to the laboratory
- - percentage of people who attend a consultation among those who are recontacted and offered an appointment
Measured: From study inclusion until completion of the care cascade, up to 3 months after inclusion
Secondary outcomes (7)
Reasons for refusal of the kit
Reasons given by participants who refuse to use the kit.
Measured: At Inclusion
Sociodemographic and clinical characteristics of the study population
Description of the sociodemographic and clinical characteristics of the people included in the study
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 3 months after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- CeGIDD - Free Information, Screening and Diagnosis Centre of Montpellier University Hospital, Médecins du Monde (ROSELA Programme)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788599
- Sponsor's protocol ID
- RECHMPL26_0173_9522
- Other IDs
- 2026-A01033-48
- Acronym
- ROSE
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renforcement, Orientation, Santé, Empowerment
- ClinicalTrials.gov ID
- NCT07788599
- Acronym / sponsor ID
- ROSE / RECHMPL26_0173_9522
- Conditions
- HIV Infection, Syphilis, Gonorrhea Infection, Chlamydia Infection, Hepatitis B, Hepatitis C
- Keywords
- Screening, Self-sampling, Access to healthcare, Sex workers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- CeGIDD - Free Information, Screening and Diagnosis Centre of Montpellier University Hospital, Médecins du Monde (ROSELA Programme)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-sampling group | Other | Other: Self-sampling for six sexually transmitted infectionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-sampling for six sexually transmitted infectionsParticipants 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. | Other | Self-sampling group |
Primary outcome
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
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
7 secondary outcomes
Reasons for refusal of the kit
Time frame: At Inclusion
Sociodemographic and clinical characteristics of the study population
Time frame: At inclusion
Screening for at least one of the six STIs before and 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
Time frame: At inclusion and through study completion, up to 3 months after inclusion
Number of outreach activities
Time frame: Throughout the 1-year enrollment period
Number of people involved in outreach activities
Time frame: Throughout the 1-year enrollment period
Prevalence of the six sexually transmitted infections
Time frame: Up to 3 months after study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling for six sexually transmitted infections in people with HIV Infection and Syphilis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène DONNADIEU, MD (00 33 4 67 33 70 20, h-donnadieu@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.