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)

June 8, 2022 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Primary endpoint is the healthcare retention rate over the first 48 weeks study.
Time Frame: 48 weeks
48 weeks
Primary endpoint is the healthcare retention rate over the 96 weeks study.
Time Frame: 96 weeks
96 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48
Time Frame: Weeks 48
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
Weeks 96
Epidemiological and clinical data assessment.
Time Frame: Week 96
Week 96
3. PrEP adherence questionnaire at W-4
Time Frame: Week- 4
Week- 4
3. PrEP adherence questionnaire at Week 4
Time Frame: Week 4
Week 4
3. PrEP adherence questionnaire at Week 12
Time Frame: Week 12
Week 12
3. PrEP adherence questionnaire at Week 24
Time Frame: Week 24
Week 24
3. PrEP adherence questionnaire at Week 48
Time Frame: Week 48
Week 48
3. PrEP adherence questionnaire at Week 96
Time Frame: Week 96
Week 96
Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96.
Time Frame: Week 96
Week 96
Concomitant treatment (including hormonal therapy) from W-4 to W96.
Time Frame: Week 96
Week 96
Number of HIV seroconversion from D1 to W96.
Time Frame: Week 96
Week 96
Incidence of sexually transmitted infections from D1 to W96.participants
Time Frame: week 96
week 96
8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time Frame: Week -4
Week -4
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time Frame: Week 24
Week 24
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time Frame: Week 48
Week 48
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time Frame: Week 96
Week 96
Precariousness score from W-4 to W96
Time Frame: Week -4
Week -4
Precariousness score from W-4 to W96
Time Frame: Day 1
Day 1
Precariousness score from W-4 to W96
Time Frame: Week 24
Week 24
Precariousness score from W-4 to W96
Time Frame: Week 48
Week 48
Precariousness score from W-4 to W96
Time Frame: Week 96
Week 96
Multi modal intervention compliance from D1 to W96
Time Frame: Week 96
Week 96
Satisfaction questionnaire from D1 to W96
Time Frame: Day 1
Day 1
Satisfaction questionnaire from D1 to W96
Time Frame: Week 12
Week 12
Satisfaction questionnaire from D1 to W96
Time Frame: Week 24
Week 24
Satisfaction questionnaire from D1 to W96
Time Frame: Week 48
Week 48
Satisfaction questionnaire from D1 to W96
Time Frame: Week 96
Week 96
Global quality of life questionnaire from W-4 to W96.
Time Frame: Week-4
Week-4
Global quality of life questionnaire from W-4 to W96.
Time Frame: Day1
Day1
Global quality of life questionnaire from W-4 to W96.
Time Frame: Week 24
Week 24
Global quality of life questionnaire from W-4 to W96.
Time Frame: Week 48
Week 48
Global quality of life questionnaire from W-4 to W96.
Time Frame: Week 96
Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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