The Women TAF-FTC Benchmark Study (NCT05140954) | Clinical Trial Compass
CompletedPhase 2/3
The Women TAF-FTC Benchmark Study
Kenya54 participantsStarted 2023-04-10
Plain-language summary
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure prophylaxis (PrEP) therapy with tenofovir alafenamide-emtricitabine (TAF-FTC). Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 18 weeks.These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.
Who can participate
Age range
18 Years – 30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 and ≤30 years old
* Willing to undergo urine pregnancy tests
* Has understood the information provided and has provided written informed consent before any study-related procedures are performed.
* HIV uninfected based on negative HIV rapid tests, according to Kenyan national algorithm
* Normal renal function (estimated glomerular filtration rate \>60 mL/min)
* Hepatitis B surface Ag negative
* No active clinically significant medical or psychiatric conditions that, in the opinion of the investigators, would interfere with study participation
* Lack of severe anemia (Hemoglobin \>10 g/dL)
* Willing to use DOT and come to clinic frequently for DOT PrEP for at least 10 weeks
* Willing to have home visits for follow up
* Has access to an active smartphone to allow off-site observation of dosing if unable to come to the clinic or as determined by the study staff, the participant resides in close location to clinic to permit home visit if unable to come to the clinic. i.e., potential participants without a smartphone may be enrolled in the study if investigator determines that the participant resides within reasonable distance from the clinic that would permit home visit id the participant misses their visit.
* Intention to stay within the study site's catchment area for at least 10 weeks.
* Resides or works in catchment area with high speed internet coverage to permit video streaming
* Not pregnant or breast feeding
* Willing to use effective contra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied TAF-FTC as PrEP specifically in women — since it's now completed, has the data been published, and what did it show about how well the drug levels in blood predict protection against HIV in women compared to men?
2The trial measured drug concentrations in both dried blood spots and blood cells at different time points — can you explain what those measurements mean for how consistently I'd need to take this medication to maintain protective levels?
3Since this was a Phase 2/3 trial, what do we know so far about the safety and side effect profile of TAF-FTC based on this study's adverse event data, and are there any risks that seem to affect women specifically?
4Given that this study is completed but may still be going through analysis or peer review, is TAF-FTC already approved and available as PrEP for women, or would I need to consider a different option like TDF-FTC while we wait for more guidance?
5How do the drug level benchmarks established in this trial compare to what's been studied in men, and does that difference affect how you would personally recommend dosing or monitoring PrEP for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Adverse Events
Timeframe: Assessed through the 10 week DOT dosing period
2
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Ten Weeks in Dried Blood Spots (DBS)
Timeframe: Assessed at week 10
3
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Four Weeks in Peripheral Blood Mononuclear Cells (PBMCs)
Timeframe: Assessed at week 4
4
Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)