NCT05689281 · CrescentCare
Increasing PrEP With Trans Women in the Deep South
(T'Cher)
What this study is about
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single treatment group$1 stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study treatment group$1.
View original scientific description
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Declaration of willingness to comply with all study procedures and availability during the study
- Age 18 years old or older
- Male sex designated at birth
- Identify as trans woman, woman or another gender identity not associated with being a man
- Desire to use or re-start PrEP
- HIV uninfected
- Speaks English or Spanish
- Live in the New Orleans metropolitan statistical area (which includes 8 parishes)
Exclusion criteria
- Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
- Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
- Concurrent or planned enrollment in a research study that provides PrEP
- Unwilling to attend quarterly follow-up visits, which will include survey participation
- Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Where
- New Orleans, Louisiana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2023 · Source of record for eligibility and locations