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.
Study Type
OBSERVATIONAL
Enrollment
100
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
Primary endpoint is the healthcare retention rate over the first 48 weeks study.
Time frame: 48 weeks
Primary endpoint is the healthcare retention rate over the 96 weeks study.
Time frame: 96 weeks
1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48
Time frame: Weeks 48
2. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W96.
Time frame: Weeks 96
Epidemiological and clinical data assessment.
Time frame: Week 96
3. PrEP adherence questionnaire at W-4
Time frame: Week- 4
3. PrEP adherence questionnaire at Week 4
Time frame: Week 4
3. PrEP adherence questionnaire at Week 12
Time frame: Week 12
3. PrEP adherence questionnaire at Week 24
Time frame: Week 24
3. PrEP adherence questionnaire at Week 48
Time frame: Week 48
3. PrEP adherence questionnaire at Week 96
Time frame: Week 96
Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96.
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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.
Time frame: Week 96
Concomitant treatment (including hormonal therapy) from W-4 to W96.
Time frame: Week 96
Number of HIV seroconversion from D1 to W96.
Time frame: Week 96
Incidence of sexually transmitted infections from D1 to W96.participants
Time frame: week 96
8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week -4
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week 24
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week 48
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week 96
Precariousness score from W-4 to W96
Time frame: Week -4
Precariousness score from W-4 to W96
Time frame: Day 1
Precariousness score from W-4 to W96
Time frame: Week 24
Precariousness score from W-4 to W96
Time frame: Week 48
Precariousness score from W-4 to W96
Time frame: Week 96
Multi modal intervention compliance from D1 to W96
Time frame: Week 96
Satisfaction questionnaire from D1 to W96
Time frame: Day 1
Satisfaction questionnaire from D1 to W96
Time frame: Week 12
Satisfaction questionnaire from D1 to W96
Time frame: Week 24
Satisfaction questionnaire from D1 to W96
Time frame: Week 48
Satisfaction questionnaire from D1 to W96
Time frame: Week 96
Global quality of life questionnaire from W-4 to W96.
Time frame: Week-4
Global quality of life questionnaire from W-4 to W96.
Time frame: Day1
Global quality of life questionnaire from W-4 to W96.
Time frame: Week 24
Global quality of life questionnaire from W-4 to W96.
Time frame: Week 48
Global quality of life questionnaire from W-4 to W96.
Time frame: Week 96