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HIVE-PrevenTNCT07516691

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

An observational study of HIV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
How many people
250 participants
Where
1 siteFrance
Study dates
1 May 2026to 1 May 2028
Phase
Observational
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
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • '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
Show all 11Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

France1 site
  • Hôpital Bichat-Claude Bernard

    Paris, Ap-hp DRCI, 75018

    Valentina Isernia, MD, 01 40 25 62 08, valentina.isernia@aphp.fr

    Jade Ghosn, MD, PHD, 01 40 25 88 60, jade.ghosn@aphp.fr

Other trials in France

About this study

Official title: 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 E-PrevenT

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.

Read more

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.

Read the detailed description

The risk of HIV infection is very high among trans people and many authors have described a state of emergency, especially for trans women. In 2021, a systematic review showed an HIV prevalence of 19.9% (95% CI 14.7% - 25.1%) among trans women globally, compared to 2.6% among trans men. A 2018 meta-analysis found that about 14% of trans women are living with HIV in the United States, the prevalence is 44% among African-American trans women, 26% among Hispanic/Latina FTs, and 7% among Caucasian trans women.

In a 2010 French study, the prevalence of HIV in a group of trans women was 6.9%.

Data on HIV prevalence among trans men are very limited, but some series show a high risk of exposure among trans men who have sex with cisgender men. However, some research shows that those who report sex with cisgender men may be at high risk of HIV.

The high prevalence of HIV in the trans population can be explained by multifactorial components.

The main risk factors for HIV in this population are receptive and insertive anal intercourse not protected by condoms, multiple sexual partners, sex work, sexually transmitted infections and needle sharing for injecting drugs and hormones.

Physical violence, sexual assault and lack of social and family support are social risk factors.

Access to care and preventive services is very limited in this socio-economic context. The population of trans people and their clients is a population very exposed to the risk of HIV and yet it is a ""hidden"" population, unknown to HIV and STI prevention services.

The penalization of sex worker clients in force in France since 2016 makes this population even more difficult to target by preventive measures.

The Ile-de-France region is the metropolitan region most affected by HIV, it is the territory where the undiagnosed epidemic is the largest: 42% of the total number of people unaware of their HIV-positive status in France live in the Île-de-France region.

Today, HIV prevention is based on condoms, testing, harm reduction for drug users, post-exposure treatment, pre-exposure prophylaxis (PrEP), treatment as prevention (TasP).

According to the national sexual health strategy set up by the Ministry of Health and Prevention and the plan ""For an AIDS-free Île-de-France region"" to put an end to HIV/AIDS, an effective and fluid pathway must be implemented combining prevention via all existing tools, early and regular screening and rapid treatment in the event of discovery of HIV-positive status. Innovative public health strategies need to be put in place to target key populations in the fight against HIV.

In this context, the E-PrevenT project proposes an innovative preventive system, based on a digital solution and targeting one of the populations most exposed to HIV and at the same time one of the most hidden preventive services (trans sex workers), with the implementation of a system that can have a direct impact on the chains of contamination (customers).

To our knowledge, no preventive program to date has targeted the population of trans sex worker clients.

The implementation of innovative, community-based and multidisciplinary preventive programs to bring these specific populations closer to care is a necessary and urgent need.

With the aim of targeting HIV/STI testing for the population of transgender people and its partners and offering preventive treatment for HIV (PrEP), actions have been carried out by the CeGIDD of the Infectious Diseases Department of the Bichat Hospital in partnership with the Acceptess-T association.

Acceptess-T is an association by and for trans people from the fight against HIV/AIDS and the activism of trans women in Latin America. For more than ten years, the association has mainly welcomed allophone trans women, migrants and sex workers, and offers various services to improve the social integration and access to health care of this population. In 2023, about 2,800 people, including 1400 trans women, per year came to the association for various reasons.

Experience of the team in the framework of the E-health preventive project:

Since October 2020, Acceptess-T has been conducting an online prevention strategy offering self-test mailings, screening support, and sexual health counselling interviews by peers. This strategy was implemented during the Covid-19 health crisis: faced with the impossibility of carrying out actions ""outside the walls"" The association has decided to invest in virtual spaces for meeting and sex work. Continued after the end of the health crisis, this action made it possible to note the importance of digital prevention for sexual health prevention and in particular HIV: the virtual world appears to be a major space for meeting, sex work but also prevention and health. The online prevention strategy implemented by Acceptess-T is aimed at trans people, transvestites, and their partners. The dating websites frequented by the target audiences bring together audiences who are particularly isolated from local associations and CEGIDDs. Dating sites frequented by the trans escort, transvestite and her partners/clients target a population that is rarely encountered in ""physical"" community spaces. The global approach of people and the bond of trust made possible by a ""peer"" approach allows for in-depth exchanges: conversations on sexual health are initiated and the proposal is made to send kits containing one or more self-tests, as well as masks, condoms, and gel. Implemented since September 2020, this online prevention strategy has shown encouraging results in view of the number of positive HIV test returns (out of 353 HIV self-tests sent in 2023, 150 negative results were returned and referred to PrEP, and 2 positive results were returned and referred for confirmation and treatment).

As part of the partnership between Acceptess-T and the CEGIDD/SMIT of Bichat, the ""E-health"" system has been in place since October 2022.

Its objective is to bring trans people, transvestites and their distant partners closer to the health system to care through teleconsultation (TC) in sexual health.

People are contacted by the health mediator of the Acceptess-T association via social networks. She offers them a TC appointment with a doctor from the CeGIDD of the Bichat hospital on dedicated E-health slots (at a rate of 2 slots per week). The appointment is set on ORBIS with the ORTIF teleconsultation option by collecting the participant's telephone number and email address, which are essential data for the technical implementation of the CT. The ORTIF application (Ile-de-France Regional Telemedicine Tool) generates the automatic sending of reminder sms/emails with connection procedures. On the day of the CT, the doctor and the patient connect via their smartphone or PC equipped with a camera. The patient has the ability to upload documents in advance of the CT. Similarly, the doctor can, at the end of the CT, upload the prescriptions to be downloaded by the patient.

More specifically, it is a question of offering up to two sexual health teleconsultations per person: a first CT with prescription of the biological assessment according to the risk analysis, followed by a second CT with analysis of the biological results, possible prescription of PrEP and referral to the conventional care system (general practitioner, CeGIDD, sexual health center, …) for the rest of the treatment. A partnership with a Parisian sexual health center (Les Bluets) has been established to facilitate the continuity of care.

The first results of this system conducted in the context of care show that between 10/2022 and 11/2025, 126 people had access to the system and 18% are trans women. Half of the people who consulted are partners of trans or transvestite people and no user of this device identifies as a client of trans women.

These data highlight the need and urgency to implement sexual health strategies to reach populations far from prevention programs, particularly trans sex workers and their clients.

We consider confidential teleconsultation to be one of the key points of this strategy, considering that our program targets penalized populations (HCWs and their clients), with priority needs for confidentiality and discretion.

Description of the searched item(s):

The E-prevenT program proposes to implement the preventive strategies already put in place by our group, to specifically target the population of trans people who are far from the health system and the population of clients.

With this objective we offer 2 methods of recruitment for people who use the E-prevent teleconsultation:

  1. The proposal of teleconsultation in sexual health via dating sites ""escort clients"": a strategy already used by our working group in the E-health project but proposed in this project by targeting the population of trans sex workers (trans women and trans men) and its clients via dating sites in exchange for money.
  2. Recruitment method called RDS (for Respondent Driven Sampling). Through this method, trans sex workers ""seeds"" people will receive training in sexual health They will be asked to recruit users among their customers (""fruit"") via the distribution of coupons. The RDS method was introduced by Heckathorn in 1997 by taking advantage of the fact that some populations often operate in networks. Although less efficient than a conventional sampling method, the RDS method is considered a good alternative for the study of hard-to-reach and networked populations. This method consists of chain sampling based on the initial subjects to generate other participants incorporating several methodological and statistical tools in order to limit the biases related to the non-random sampling method: a certain number of people from the target population are initially recruited, they are called ""seeds""; The latter, in turn, recruit a limited number of other people from the target population of their social community/network (""fruits"").

The RDS method has already been successfully used to recruit MSM in antiretroviral treatment programs or in vaccine clinical trials. It has been particularly useful for recruiting MSM who are marginalized (from disadvantaged backgrounds, homeless, commercial sexual activities), or who do not identify as gay or bisexual.

The RDS method therefore appears to be suitable for targeting the trans sex worker population and its clients.

We consider that this study design, even if it is not intended to be sustained after the end of funding, can provide key results in terms of identifying and mobilizing key populations, traditionally very distant from the healthcare system. It will also produce innovative data on a strategy based on the empowerment of transgender women sex workers, a population particularly exposed to stigma and discrimination.

The fight against discrimination and the empowerment of vulnerable populations are indeed essential levers in the fight against HIV and sexual health prevention.

Conditions
HIV
Keywords
hiv, transgender sex workers
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07516691
Study groupRoleWhat they receive
Population of the "escort clients" dating strategyDating 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (7)
  1. Socio-epidemiological characteristics of users who join the E-PrevenT system.

    The objective is to describe the socio-epidemiological characteristics of the transgender (SW) population and their clients who join the E-PrevenT strategy.

    Measured: 2 years

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

    Objective is to assess the access of the transgender (SW) population and their clients to HIV/STI screening with the E-PrevenT system.

    Measured: 2 years

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

    The objective is to determine HIV and STI prevalence in the study population

    Measured: 2 years

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

    The objective is to evaluate the PREP access for seronegative trans SW and clients

    Measured: 2 years

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

    The objective is to provide sexual health and STI prevention training for a group of trans sex workers

    Measured: 2 years

  6. Number of clients recruited (for at least one teleconsultation) by each trans sex workers trained in the E-PrevenT sexual health program

    The objective is to empower a group of trans sex workers to promote sexual health in their networks and clients.

    Measured: 2 years

  7. Register of difficulties in using the digital teleconsultation tool reported in medical record

    The objective is to assess the difficulties in using the digital teleconsultation tool

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07516691
Sponsor's protocol ID
APHP251360
Other IDs
2025-A02904-45
Acronym
E-PrevenT
Status last verified
Mar 2026
First submitted
1 Apr 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by Assistance Publique - Hôpitaux de Paris 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 11 inclusion and 1 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 8 Apr 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 Valentina Isernia, MD (01 40 25 62 08, valentina.isernia@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of trans sex workers or clients who joined the E-PrevenT system during the study period. (time frame: 2 years). 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 8 Apr 2026.

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