NCT07516691

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: France