Clinical trial NCT05415930: 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.
Official title: Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transgenderism
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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;

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.


Eligibility criteria: 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.

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