Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition HIV Prophylaxis (PrEP) Prescription and Retention in Care, in a Group of Trans Womens (TW) at High Risk of HIV Infection.

Transgenderism Clinical Trial

— PrEP à porter  

Official title:

Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05415930
• Other study ID #: IMEA 066
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2022
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Contact: Valentina ISERNIA
• Phone: +331 40256208
• Email: valentina.isernia[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of an adaptative, multidisciplinary, reach-out program, facilitating pre exposition HIV prophylaxis (PrEP) prescription and retention in care, in a group of trans womens (TW) at high risk of HIV infection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Trans woman = 18 years old; Negative HIV-1 and HIV-2 serology; Participant on PrEP or request to start PrEP or reporting present, past or future exposure to HIV; Participant agreed with the constraints imposed by the study (every 3 months visits); Non opposition.

Exclusion Criteria:

• Subject with positive HIV serology; Subject with clinical signs suggesting a primary HIV infection; Subjects planning to travel/live abroad for more than 3 consecutive months or planning to live outside Ile-de-France region; Creatinine clearance < 60 mL/min (Cockroft's formula); History of chronic kidney disease, osteoporosis, osteopenia; Subject receiving a potentially nephrotoxic treatment (long-term nonsteroidal anti-inflammatory drugs); Ongoing post-exposure antiretroviral therapy (the participant may be tested 6 weeks after the end of treatment); Treatment under investigation; Chronic gastrointestinal illness (or chronic nausea or vomiting) interfering with intestinal absorption; HBs antigen positive or with an isolated anti-HBc antibody if participant is not ready to take continuous PrEP; Life-threatening illness (cancer) or other serious illness (cardiovascular, renal, pulmonary, unstable diabetes) which would require treatment that could interfere with treatment adherence; Hypersensitivity to one of the components of TDF / FTC.

Related Conditions & MeSH terms

• Transgenderism

Intervention

Other:
• Psychosocial assistance
Firs evaluation at Acceptess-T locals by a health mediator specialised in transidentity : advice for administrative procedures (health insurance, residency permit, housing, etc.) management of others social issues Orientation to Acceptess-T sexual health space for medical evaluation Orientation to Acceptess-T mental health space if needed : special focus on sexual health and gender related issues
• Medical care
Sexual health clinics at Acceptess-T health space First STI risk evaluation: HIV, HCV, HBV, syphilis TROD realisation Spanish speaking Infectious Diseases (ID) specialist (from ID Department of Bichat hospital) first evaluation Proposition of PrEP if indicated Orientation for hospital follow-up in dedicate PrEP clinics Prescription and follow-up of a feminazing hormonal therapy if needed
• Legal-Administrative Assistance
Legal counselling, provided by a sex worker union representative Access to FAST (fond action social trans) which give an economic help to TW in high precarity situations
• Focus Group
A group of 10-15 TW, identified through convenience sampling, along with the Acceptess-T "Health Space" multidisciplinary team will be invited to participate in an Human Centered Design (HCD) project. The project will be led by a team of anthropologists and sociologists and exchanges will be recorded and fully transcribed and analysed by a person competent in qualitative methodology. The objective will be to co-create tailored solutions that meet the needs of TW and are viable to implement within the health system, so TW can be better managed The solutions ideated will work synergistically towards improving TW PrEP access and adherence and health system retention.This is an adaptative program : if new solutions to face PrEP barriers are created during the study follow-up, new mesures will be added to the intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is the healthcare retention rate over the first 48 weeks study.		48 weeks
Primary	Primary endpoint is the healthcare retention rate over the 96 weeks study.		96 weeks
Secondary	1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48		Weeks 48
Secondary	2. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W96.		Weeks 96
Secondary	Epidemiological and clinical data assessment.		Week 96
Secondary	3. PrEP adherence questionnaire at W-4		Week- 4
Secondary	3. PrEP adherence questionnaire at Week 4		Week 4
Secondary	3. PrEP adherence questionnaire at Week 12		Week 12
Secondary	3. PrEP adherence questionnaire at Week 24		Week 24
Secondary	3. PrEP adherence questionnaire at Week 48		Week 48
Secondary	3. PrEP adherence questionnaire at Week 96		Week 96
Secondary	Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96.		Week 96
Secondary	Concomitant treatment (including hormonal therapy) from W-4 to W96.		Week 96
Secondary	Number of HIV seroconversion from D1 to W96.		Week 96
Secondary	Incidence of sexually transmitted infections from D1 to W96.participants		week 96
Secondary	8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.		Week -4
Secondary	Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.		Week 24
Secondary	Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.		Week 48
Secondary	Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.		Week 96
Secondary	Precariousness score from W-4 to W96		Week -4
Secondary	Precariousness score from W-4 to W96		Day 1
Secondary	Precariousness score from W-4 to W96		Week 24
Secondary	Precariousness score from W-4 to W96		Week 48
Secondary	Precariousness score from W-4 to W96		Week 96
Secondary	Multi modal intervention compliance from D1 to W96		Week 96
Secondary	Satisfaction questionnaire from D1 to W96		Day 1
Secondary	Satisfaction questionnaire from D1 to W96		Week 12
Secondary	Satisfaction questionnaire from D1 to W96		Week 24
Secondary	Satisfaction questionnaire from D1 to W96		Week 48
Secondary	Satisfaction questionnaire from D1 to W96		Week 96
Secondary	Global quality of life questionnaire from W-4 to W96.		Week-4
Secondary	Global quality of life questionnaire from W-4 to W96.		Day1
Secondary	Global quality of life questionnaire from W-4 to W96.		Week 24
Secondary	Global quality of life questionnaire from W-4 to W96.		Week 48
Secondary	Global quality of life questionnaire from W-4 to W96.		Week 96