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.
PrEP à porter
1 other identifier
observational
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedJune 13, 2022
April 1, 2022
1.9 years
April 20, 2022
June 8, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Primary endpoint is the healthcare retention rate over the first 48 weeks study.
48 weeks
Primary endpoint is the healthcare retention rate over the 96 weeks study.
96 weeks
Secondary Outcomes (33)
1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48
Weeks 48
2. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W96.
Weeks 96
Epidemiological and clinical data assessment.
Week 96
3. PrEP adherence questionnaire at W-4
Week- 4
3. PrEP adherence questionnaire at Week 4
Week 4
- +28 more secondary outcomes
Interventions
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
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 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
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.
Eligibility Criteria
Trans woman , Negative HIV-1 and HIV-2 serology; Participant on PrEP or request to start PrEP or reporting present, past or future exposure to HIV;
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2022
First Posted
June 13, 2022
Study Start
July 1, 2022
Primary Completion
May 30, 2024
Study Completion
February 28, 2025
Last Updated
June 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share