Strengthening, Guidance, Health, Empowerment

NCT07788599 | Not Yet Recruiting

• 2 other identifiers: RECHMPL26_0173_95222026-A01033-48
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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

  From study inclusion until completion of the care cascade, up to 3 months after inclusion

Secondary Outcomes (7)

• Reasons for refusal of the kit

  At Inclusion

• Sociodemographic and clinical characteristics of the study population

  At inclusion

• Screening for at least one of the six STIs before and during the intervention

  At inclusion and through study completion, up to 3 months after inclusion

• Screening for each of the six STIs before and during the intervention

  At inclusion and through study completion, up to 3 months after inclusion

• Number of outreach activities

  Throughout the 1-year enrollment period

Study Arms (1)

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.

Other: Self-sampling for six sexually transmitted infections

Interventions

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.

Self-sampling group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to understand the study
• Being under guardianship, curatorship or a future protection mandate

Sponsors & Collaborators

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

Study Sites (1)

ROSELA _ Médecins du Monde

Montpellier, Hérault, 34 000, France

Location

MeSH Terms

Conditions

HIV Infections; Syphilis; Chlamydia Infections; Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hélène DONNADIEU, MD

CONTACT

00 33 4 67 33 70 20; h-donnadieu@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

FR (1)