PrEP à porter: 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.
Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05415930
Collaborator
(none)
100
32
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition
Anticipated Study Start Date
:
Jul 1, 2022
Anticipated Primary Completion Date
:
May 30, 2024
Anticipated Study Completion Date
:
Feb 28, 2025
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT05415930
Other Study ID Numbers:
- IMEA 066
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No