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.
Not yet recruiting
- Conditions
- Transgenderism
- Registration Number
- NCT05415930
- Lead Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the healthcare retention rate over the 96 weeks study. 96 weeks Primary endpoint is the healthcare retention rate over the first 48 weeks study. 48 weeks
- Secondary Outcome Measures
Name Time Method Epidemiological and clinical data assessment. Week 96 8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96. Week -4 Precariousness score from W-4 to W96 Week 96 2. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W96. Weeks 96 3. PrEP adherence questionnaire at W-4 Week- 4 3. PrEP adherence questionnaire at Week 96 Week 96 Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96. Week 96 3. PrEP adherence questionnaire at Week 4 Week 4 Number of HIV seroconversion from D1 to W96. Week 96 Incidence of sexually transmitted infections from D1 to W96.participants week 96 3. PrEP adherence questionnaire at Week 12 Week 12 3. PrEP adherence questionnaire at Week 48 Week 48 Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96. Week 96 Multi modal intervention compliance from D1 to W96 Week 96 1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48 Weeks 48 3. PrEP adherence questionnaire at Week 24 Week 24 Concomitant treatment (including hormonal therapy) from W-4 to W96. Week 96 Satisfaction questionnaire from D1 to W96 Week 96 Global quality of life questionnaire from W-4 to W96. Week 96