Evaluation of a New Strategy to Approach the Transgender Sex Worker Populations and Their Clients for Access to a Preventive Sexual Health System Through the ORTIF Digital Teleconsultation Solution

NCT07516691 | Not Yet Recruiting

• 2 other identifiers: APHP2513602025-A02904-45
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of HIV (Human Immunodeficiency Virus) and STIs (Sexually Transmitted Infections) is very high in the trans population, due to multifactorial components. The main risk factors for HIV in this population are unprotected receptive and insertive anal intercourse, multiple sexual partners, sex work, needles share for injecting drugs and hormones. Physical violence, sexual assault and lack of social and family support are supplementary social risk factors. Healthcare access is very limited in this socio-economic context. The population of transgender persons and their transmission chains (partners, clients, etc.) are highly exposed to HIV risk, but they are still "hidden" populations, not targeted by prevention programs. Innovative preventive strategies can improve sexual health services access for these specific populations.

Conditions

HIV

Keywords

hiv; transgender sex workers

Outcome Measures

Primary Outcomes (1)

• Number of trans sex workers or clients who joined the E-PrevenT system during the study period.

  Objective is to assess the access of the transgender sex worker population and their clients to an innovative preventive sexual health program, based on the ORTIF digital teleconsultation solution.

  2 years

Secondary Outcomes (7)

• Socio-epidemiological characteristics of users who join the E-PrevenT system.

  2 years

• Number of HIV/STI screening performed for trans SW or clients via the E-PrevenT system.

  2 years

• Number of positive HIV serologies and positive STI screenings out of the total number of tests performed in the study population

  2 years

• Number of trans sex workers or clients starting PrEP via the E-PrevenT system.

  2 years

• Number of trans sex workers trained in sexual health and STI prevention via E-PrevenT program

  2 years

Study Arms (2)

Population of the "escort clients" dating strategy

Dating site users (trans sex workers and their clients)

Population of the RDS strategy (Respondent Driven Sampling)

Seeds: trans SW on sex work followed-up in health programs of Bichat Acceptess- T. Seeds with regular follow-up and regular clients will be preferred. Fruits: clients invited by trans SW to participate to E-PrevenT programs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of the "escort clients" dating strategy: Dating site users (trans sex workers and their clients) Population of the RDS strategy (Respondent Driven Sampling) : Seeds: trans SW on sex work followed-up in health programs of Bichat Acceptess- T. Seeds with regular follow-up and regular clients will be preferred. Fruits: clients invited by trans sex workers to participate to E-PrevenT programs

You may qualify if:

• 'For population of E-prevent telemedicine service users :
• Individuals aged ≥18 years
• Registered on a trans escort-client dating website or having sexual relations with trans individuals in exchange for money
• Agreeing to complete at least one teleconsultation through the E-PrevenT program
• Agreeing to provide a phone number and an email address for the teleconsultation
• No verbal objection to participating in the study
• For population of trans individuals invited to collaborate in the study (seeds of the RDS strategy):
• Trans or non-binary individuals aged ≥18 years
• Engaged in sexual activity in exchange for money (sex work)
• Commitment to complete sexual health training sessions (twice per year)
• No verbal objection to participating in the study

You may not qualify if:

• Person under guardianship, curatorship or other French legal protections schemes

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, Ap-hp DRCI, 75018, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Valentina Isernia, MD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Isernia, MD

CONTACT

01 40 25 62 08; valentina.isernia@aphp.fr

Jade Ghosn, MD, PHD

CONTACT

01 40 25 88 60; jade.ghosn@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)