TransgenderismPrEP à porterNCT05415930
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.
An observational study of Transgenderism, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Transgenderism
- What is being tested?
- Psychosocial assistance, Medical care and Legal-Administrative Assistance
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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;
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Transgenderism
- Being tested
- Psychosocial assistance, Medical care, Legal-Administrative Assistance, Focus Group
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial assistanceOther
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 careOther
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 AssistanceOther
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 GroupOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the healthcare retention rate over the first 48 weeks study.
Measured: 48 weeks
Primary endpoint is the healthcare retention rate over the 96 weeks study.
Measured: 96 weeks
Secondary outcomes (33)
1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48
Measured: Weeks 48
2. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W96.
Measured: Weeks 96
Epidemiological and clinical data assessment.
Measured: Week 96
3. PrEP adherence questionnaire at W-4
Measured: Week- 4
3. PrEP adherence questionnaire at Week 4
Measured: Week 4
3. PrEP adherence questionnaire at Week 12
Measured: Week 12
3. PrEP adherence questionnaire at Week 24
Measured: Week 24
3. PrEP adherence questionnaire at Week 48
Measured: Week 48
3. PrEP adherence questionnaire at Week 96
Measured: Week 96
Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96.
Measured: Week 96
Concomitant treatment (including hormonal therapy) from W-4 to W96.
Measured: Week 96
Number of HIV seroconversion from D1 to W96.
Measured: Week 96
Incidence of sexually transmitted infections from D1 to W96.participants
Measured: week 96
8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Measured: Week -4
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Measured: Week 24
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Measured: Week 48
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Measured: Week 96
Precariousness score from W-4 to W96
Measured: Week -4
Precariousness score from W-4 to W96
Measured: Day 1
Precariousness score from W-4 to W96
Measured: Week 24
Precariousness score from W-4 to W96
Measured: Week 48
Precariousness score from W-4 to W96
Measured: Week 96
Multi modal intervention compliance from D1 to W96
Measured: Week 96
Satisfaction questionnaire from D1 to W96
Measured: Day 1
Satisfaction questionnaire from D1 to W96
Measured: Week 12
Satisfaction questionnaire from D1 to W96
Measured: Week 24
Satisfaction questionnaire from D1 to W96
Measured: Week 48
Satisfaction questionnaire from D1 to W96
Measured: Week 96
Global quality of life questionnaire from W-4 to W96.
Measured: Week-4
Global quality of life questionnaire from W-4 to W96.
Measured: Day1
Global quality of life questionnaire from W-4 to W96.
Measured: Week 24
Global quality of life questionnaire from W-4 to W96.
Measured: Week 48
Global quality of life questionnaire from W-4 to W96.
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415930
- Sponsor's protocol ID
- IMEA 066
- Acronym
- PrEP à porter
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition
- ClinicalTrials.gov ID
- NCT05415930
- Acronym / sponsor ID
- PrEP à porter / IMEA 066
- Conditions
- Transgenderism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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;
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial assistanceFirs 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 | Other | – |
| Medical careSexual 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 | Other | – |
| Legal-Administrative AssistanceLegal 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 | Other | – |
| Focus GroupA 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. | Other | – |
Primary outcome
Primary endpoint is the healthcare retention rate over the first 48 weeks study.
Time frame: 48 weeks
Primary endpoint is the healthcare retention rate over the 96 weeks study.
Time frame: 96 weeks
33 secondary outcomes
1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48
Time frame: 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
Epidemiological and clinical data assessment.
Time frame: Week 96
3. PrEP adherence questionnaire at W-4
Time frame: Week- 4
3. PrEP adherence questionnaire at Week 4
Time frame: Week 4
3. PrEP adherence questionnaire at Week 12
Time frame: Week 12
3. PrEP adherence questionnaire at Week 24
Time frame: Week 24
3. PrEP adherence questionnaire at Week 48
Time frame: Week 48
3. PrEP adherence questionnaire at Week 96
Time frame: Week 96
Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96.
Time frame: Week 96
Concomitant treatment (including hormonal therapy) from W-4 to W96.
Time frame: Week 96
Number of HIV seroconversion from D1 to W96.
Time frame: Week 96
Incidence of sexually transmitted infections from D1 to W96.participants
Time frame: week 96
8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week -4
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week 24
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week 48
Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.
Time frame: Week 96
Precariousness score from W-4 to W96
Time frame: Week -4
Precariousness score from W-4 to W96
Time frame: Day 1
Precariousness score from W-4 to W96
Time frame: Week 24
Precariousness score from W-4 to W96
Time frame: Week 48
Precariousness score from W-4 to W96
Time frame: Week 96
Multi modal intervention compliance from D1 to W96
Time frame: Week 96
Satisfaction questionnaire from D1 to W96
Time frame: Day 1
Satisfaction questionnaire from D1 to W96
Time frame: Week 12
Satisfaction questionnaire from D1 to W96
Time frame: Week 24
Satisfaction questionnaire from D1 to W96
Time frame: Week 48
Satisfaction questionnaire from D1 to W96
Time frame: Week 96
Global quality of life questionnaire from W-4 to W96.
Time frame: Week-4
Global quality of life questionnaire from W-4 to W96.
Time frame: Day1
Global quality of life questionnaire from W-4 to W96.
Time frame: Week 24
Global quality of life questionnaire from W-4 to W96.
Time frame: Week 48
Global quality of life questionnaire from W-4 to W96.
Time frame: Week 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Transgenderism
Enrolling by invitation
Metoidioplasty and Phalloplasty Surgery Decision Making
Gender Dysphoria, Gender Dysphoria, Adult
RecruitingPhase 4
Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
Transgenderism, Reproductive Issues
RecruitingObservational study
Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Transsexualism, Transgenderism
Active, not recruitingObservational study
Cardiometabolic Health in Transgender Males
Transgender, Transgenderism
RecruitingObservational study
Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
Transgenderism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgenderism, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina ISERNIA (+331 40256208, valentina.isernia@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is the healthcare retention rate over the first 48 weeks study. (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.