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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial assistance | Other | 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 | Other | 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 | Other | 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 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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;
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina ISERNIA | Contact | +331 40256208 | valentina.isernia@aphp.fr | |
| Minerva Cervantes Gonzalez | Contact | +331 40256209 | minerva.cervantesgonzalez@aphp.fr |
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| 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 |
| 3. PrEP adherence questionnaire at Week 12 | Week 12 |
| 3. PrEP adherence questionnaire at Week 24 | Week 24 |
| 3. PrEP adherence questionnaire at Week 48 | Week 48 |
| 3. PrEP adherence questionnaire at Week 96 | Week 96 |
| Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96. | Week 96 |
| Concomitant treatment (including hormonal therapy) from W-4 to W96. | Week 96 |
| Number of HIV seroconversion from D1 to W96. | Week 96 |
| Incidence of sexually transmitted infections from D1 to W96.participants | week 96 |
| 8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96. | Week -4 |
| Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96. | Week 24 |
| Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96. | Week 48 |
| Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96. | Week 96 |
| Precariousness score from W-4 to W96 | Week -4 |
| Precariousness score from W-4 to W96 | Day 1 |
| Precariousness score from W-4 to W96 | Week 24 |
| Precariousness score from W-4 to W96 | Week 48 |
| Precariousness score from W-4 to W96 | Week 96 |
| Multi modal intervention compliance from D1 to W96 | Week 96 |
| Satisfaction questionnaire from D1 to W96 | Day 1 |
| Satisfaction questionnaire from D1 to W96 | Week 12 |
| Satisfaction questionnaire from D1 to W96 | Week 24 |
| Satisfaction questionnaire from D1 to W96 | Week 48 |
| Satisfaction questionnaire from D1 to W96 | Week 96 |
| Global quality of life questionnaire from W-4 to W96. | Week-4 |
| Global quality of life questionnaire from W-4 to W96. | Day1 |
| Global quality of life questionnaire from W-4 to W96. | Week 24 |
| Global quality of life questionnaire from W-4 to W96. | Week 48 |
| Global quality of life questionnaire from W-4 to W96. | Week 96 |
| ID | Term |
|---|---|
| D014189 | Transsexualism |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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