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NCT Number: NCT07788599

Strengthening, Guidance, Health, 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.

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Key information

Conditions

HIV Infection Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Chlamydia Infection Chlamydia Infections Chlamydiaceae Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Genital Diseases Gonorrhea Infection Gram-Negative Bacterial Infections HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ROSELA _ Médecins du Monde

Montpellier, Hérault, 34 000, France

Location contact

Aziliz ALMY

PRINCIPAL_INVESTIGATOR

Inès BOUBEKEUR

SUB_INVESTIGATOR

Victor DUPERRET

CONTACT

[email protected]

00 33 7 58 81 77 37

Victor DUPERRET

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-sampling for six sexually transmitted infections

Other

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.

Primary outcomes

  1. 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:

    • - 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

Secondary outcomes

  1. Reasons for refusal of the kit

    Time frame: At Inclusion

    Reasons given by participants who refuse to use the kit.

  2. Sociodemographic and clinical characteristics of the study population

    Time frame: At inclusion

    Description of the sociodemographic and clinical characteristics of the people included in the study

  3. 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

    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.

  4. 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

    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.

  5. Number of outreach activities

    Time frame: Throughout the 1-year enrollment period

    Number of physical and virtual outreach activities conducted by the ROSELA programme of Médecins du Monde during the study period

  6. Number of people involved in outreach activities

    Time frame: Throughout the 1-year enrollment period

    Number of people involved in conducting the physical and virtual outreach activities during the study period

  7. Prevalence of the six sexually transmitted infections

    Time frame: Up to 3 months after study inclusion

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène DONNADIEU, MD

CONTACT

[email protected]

00 33 4 67 33 70 20

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Official study title

Renforcement, Orientation, Santé, Empowerment

Acronym: ROSE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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