Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616963
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-06
First Post:
2020-07-13
Brief Title:
EmtricitabineTenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
FTAF Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis TAF4TRANS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAF4TRANS
Brief Summary:
The purpose of this study is to evaluate Pre-Exposure Prophylaxis PrEP levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy Subjects who have previously taken FTDF as PrEP will continue with a fixed dose combination of daily oral FTAF substituting for FTDF Subjects will receive the iTAB text messaging adherence reminders to provide personalized automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication This study will enroll 60 individuals to take FTAF as PrEP for 48 weeks
Detailed Description:
This is a two-phased prospective switch study of 60 transgender individuals who are eligible for Truvada EmtricitabineTenofovir Disoproxil Fumarate FTDF PrEP and who are willing to switch to Descovy EmtricitabineTenofovir Alafenamide FTAF for 48 weeks The purpose of the current study is to contribute safety and efficacy data to support the use of FTAF in transgendernon-binary individuals The current study leverages existing studies in transnon-binary populations eg CCTG 603 HRPP161807 funded by the California HIVAIDS Research Program CHRP
The dosage for Phase I is FTC 200 mg TDF 300 mg The dosage for Phase II is FTC 200 mg TAF 25 mg TDFFTC is FDA approved for use as PrEP in adults and adolescents at risk for HIV-1 FTAF has received approval by the FDA for use as PrEP as of October 3rd 2019 except for those having receptive vaginal sex The FDA has yet to approve FTAF for use in those having receptive vaginal sex due to a lack of clinical research studies specific to the population Participants will be advised that if they decide to have receptive vaginal sex while taking FTAF they should use another method of protection such as condomsEligibility criteria will be based on the CDC guidance for PrEP use in transgender persons All participants must be confirmed HIV-negative either by rapid test or AgAb test must have acceptable safety laboratory values and must currently be taking or will initiate FTDF by the ScreeningBaseline visit Participants will have a 12-week lead-in period prior to switching to FTAF At the Switch Visit participants will be instructed to substitute FTDF with FTAF for PrEP for 48 weeks Regular follow-up evaluations will occur at Weeks 12 24 36 and 48
Participants will receive health education clinical assessments laboratory safety monitoring STI and HIV screening standard HIV risk reduction and adherence counseling assessment of psychosocial barriers and completion of a computer-based self-report survey that includes assessments of adherence and risk behaviors Intracellular TFV-DP quantification will be performed in retrospect on batched banked samples and additional banked specimens will be frozen for future use Adherence by TFV-DP concentrations and self-reported measures will be used for the primary and secondary analyses of the study Additional outcomes for the study will include changes in risk behavior and determinants of PrEP adherence
This study will continue iTAB a daily text message support system for adherence up until 12 weeks after FTAF switch As needed the study will provide a subject reimbursement to pay for unlimited text messaging andor b an appropriate cell phone if a subject does not have one Daily dosing text message reminders will be sent for the duration of the study Both reminder timing and content can be individualized Participants have selected 15 personal reminders from a list of pre-determined reminders that cover various themes shown to be effective in improving adherence eg social support loss frame health gain etc as developed through focus groups and targeted group feedback These messages can be modified and the patient can choose to create their own reminders if they prefer These reminder times can vary for different days of the week to accommodate for changes in schedule eg 8 M-F and 10 AM on SatSun Once the time is identified the text reminder system is automated Patients will confirm medication taking via text responses to the personalized reminders
The dosage for Phase I is FTC 200 mg TDF 300 mg The dosage for Phase II is FTC 200 mg TAF 25 mg TDFFTC is FDA approved for use as PrEP in adults and adolescents at risk for HIV-1 FTAF has received approval by the FDA for use as PrEP as of October 3rd 2019 except for those having receptive vaginal sex The FDA has yet to approve FTAF for use in those having receptive vaginal sex due to a lack of clinical research studies specific to the population Participants will be advised that if they decide to have receptive vaginal sex while taking FTAF they should use another method of protection such as condomsEligibility criteria will be based on the CDC guidance for PrEP use in transgender persons All participants must be confirmed HIV-negative either by rapid test or AgAb test must have acceptable safety laboratory values and must currently be taking or will initiate FTDF by the ScreeningBaseline visit Participants will have a 12-week lead-in period prior to switching to FTAF At the Switch Visit participants will be instructed to substitute FTDF with FTAF for PrEP for 48 weeks Regular follow-up evaluations will occur at Weeks 12 24 36 and 48
Participants will receive health education clinical assessments laboratory safety monitoring STI and HIV screening standard HIV risk reduction and adherence counseling assessment of psychosocial barriers and completion of a computer-based self-report survey that includes assessments of adherence and risk behaviors Intracellular TFV-DP quantification will be performed in retrospect on batched banked samples and additional banked specimens will be frozen for future use Adherence by TFV-DP concentrations and self-reported measures will be used for the primary and secondary analyses of the study Additional outcomes for the study will include changes in risk behavior and determinants of PrEP adherence
This study will continue iTAB a daily text message support system for adherence up until 12 weeks after FTAF switch As needed the study will provide a subject reimbursement to pay for unlimited text messaging andor b an appropriate cell phone if a subject does not have one Daily dosing text message reminders will be sent for the duration of the study Both reminder timing and content can be individualized Participants have selected 15 personal reminders from a list of pre-determined reminders that cover various themes shown to be effective in improving adherence eg social support loss frame health gain etc as developed through focus groups and targeted group feedback These messages can be modified and the patient can choose to create their own reminders if they prefer These reminder times can vary for different days of the week to accommodate for changes in schedule eg 8 M-F and 10 AM on SatSun Once the time is identified the text reminder system is automated Patients will confirm medication taking via text responses to the personalized reminders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None