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)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Transgenderism
• Intervention / Treatment: Other: Psychosocial assistance; Other: Medical care; Other: Legal-Administrative Assistance; Other: Focus Group

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Valentina ISERNIA; Phone Number: +331 40256208; Email: valentina.isernia@aphp.fr
• Study Contact Backup: Name: Minerva Cervantes Gonzalez; Phone Number: +331 40256209; Email: minerva.cervantesgonzalez@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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;

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IMEA 066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No