HIV InfectionsPhase 2NCT05057858

The Women TDF-FTC Benchmark Study

A Phase 2 study testing co-formulated 300 mg TDF/ 200mg FTC in people with HIV Infections, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: co-formulated 300 mg TDF/ 200mg FTC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteKenya
Study dates: 25 Apr 2022to 1 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

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No active clinically significant medical or psychiatric conditions that would interfere with study participation
Lack of severe anemia
Willing to use DOT and come to clinic frequently for DOT PrEP for at least 8 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 8 weeks.
Resides or works in catchment area with high speed internet coverage to permit video streaming
Specific for non-pregnant cisgender women cohort
Not pregnant or breast feeding
At low risk for HIV. In Kenya, national guidelines define substantial risk for HIV and recommend PrEP be an option for individuals reporting: partner of HIV-infected person not on ART or on ART for <6 months, >1 partner of unknown status, transactional sex, recent STI, recurrent PEP use, inconsistent condom use, or injection drug use. So, non-pregnant cisgender women reporting any of these factors will not be eligible for the study but will be linked for PrEP at clinic of choice including at Thika Site itself.
Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP
Willingness and ability to be abstinent for at least 7 days after each vaginal biopsy visit.
Specific for pregnant cisgender women only
At screening, evidence of a viable pregnancy with gestational age of 13-26 weeks after the date of conception with sonographic confirmation. If adequate sonographic results are not available from medical records at screening, an ultrasound must be performed in the interim so that the result is available at study entry.
At elevated risk for acquiring HIV according to Kenya guideline for PrEP. This is to ensure an ethical approach for provision of PrEP in pregnancy (i.e., only exposing PrEP to those who want and might benefit from it). Kenya national guidelines define substantial risk for HIV and recommend PrEP be an option for individuals reporting partner of HIV-infected person not on ART or on ART for <6 months, >1 partner of unknown status, transactional sex, recent STI, recurrent PEP use, no or inconsistent condom use
At study entry, willing to use PrEP during pregnancy for HIV prevention

Who cannot join

For all cisgender women
Inability to give informed consent
Positive screening HIV+ as determined by standard rapid serologic assays or suspected acute HIV infection in the opinion of the clinician. (example signs and symptoms of acute HIV infection include combinations of fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy cervical or inguinal)
Positive HBV surface antigen test at screening
Calculated creatinine clearance < 60 ml/min.
Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.

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Prohibited concomitant medications are: investigational agents (within 30 days of enrollment), aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.
Current or past use of PrEP (pre-exposure prophylaxis)
Not willing to have home visits
Specific for non-pregnant cisgender women cohort
Pregnancy or plan to become pregnant in the next 6 months or unwillingness to use birth control
Current breastfeeding
High risk of HIV infection (for example: sexually active with an HIV infected partner; engages in condomless intercourse with HIV-infected partners or partner of unknown status during the study; females who exchange sex for money, shelter, or gifts; active injection drug use or during the last 12 months; newly diagnosed sexually transmitted infections in last 6 months.
Specific for pregnant cisgender women cohort
Mother has a known history of any of the following, as determined by the site investigator or designee based on maternal report and available medical records:
Sickle cell anemia (excluding sickle cell trait), chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) or other blood dyscrasias
Fetus has a known or suspected major congenital anomaly, from chart review of prior data, defined ultrasound.
Complications in prior pregnancies that would be considered exclusionary

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Kenya Medical Research Institute - Partners in Health Research and Development
Thika

Other trials in Kenya

About this study

Official title: Pharmacology of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women

The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated with HIV protection in cisgender women. Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 16 weeks. The study will also investigate how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.

Read the detailed description

This is an open-label, randomized, three-arm, directly observed therapy (DOT) study. HIV-uninfected non-pregnant cisgender women at low risk for HIV acquisition will be randomly assigned to 1 of 3 dosing frequencies of DOT with Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) oral PrEP to help differentiate poor and moderate from perfect dosing. An additional cohort of pregnant women at high risk of HIV acquisition will be recruited and will receive daily dosing of TDF/FTC oral PrEP to evaluate the impact of pregnancy on blood and cellular drug levels. Study participants will receive directly observed oral PrEP for eight weeks, and will be followed for an additional eight weeks after their final PrEP dose. Drug concentrations in blood, vaginal fluid, and tissue will be measured during the study. The primary objectives of the study are:

To define expected blood concentrations and dose-proportionality specific to cisgender women for tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) and peripheral blood mononuclear cells (PBMCs) using directly observed therapy of TDF/FTC at 2, 4, and 7 doses per week, representing poor, moderate, and perfect adherence, respectively.
To establish a model to predict adherence rate to TDF/FTC by level of TFV-DP observed in DBS for cisgender women. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapyt of TDF/FTC oral PrEP: 2, 4, or 7 doses/week to differentiate poor and moderate from perfect adherence.

The study is the first to define TDF/FTC PrEP adherence-blood concentration thresholds for African cisgender women, a priority population for HIV prevention. The findings will guide accurate interpretation of adherence and success of PrEP programs in cisgender women. This data will also help guide decisions on optimal PrEP dosing for pregnant cisgender women at risk of acquiring HIV in Africa.

Conditions: HIV Infections
Being tested: co-formulated 300 mg TDF/ 200mg FTC
Keywords: Pre-exposure Prophylaxis, HIV, Kenya
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

co-formulated 300 mg TDF/ 200mg FTCDrug
Also called Truvada
Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC

Study groups in NCT05057858
Study group	Role	What they receive
Perfect Adherence	Experimental	Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). Receives: Drug: co-formulated 300 mg TDF/ 200mg FTC
Moderate Adherence	Experimental	Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday) Receives: Drug: co-formulated 300 mg TDF/ 200mg FTC
Poor Adherence	Experimental	Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday) Receives: Drug: co-formulated 300 mg TDF/ 200mg FTC
Pregnant	Experimental	Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). Receives: Drug: co-formulated 300 mg TDF/ 200mg FTC

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentrations of Tenofovir Disphosphate (TFV-DP) Measured at Eight Weeks in Dried Blood Spots (DBS)
TFV-DP concentrations observed in dried blood spots (DBS) after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively. Emtricitabine triphosphate FTC-TP measures are not reported, as FTC-TP was not quantifiable in DBS samples from 100%, 81%, and 21% percent of participants receiving 2, 4, and 7 doses per week, respectively.
Measured: Assessed at 8 weeks
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Steady-state in Peripheral Blood Mononuclear Cells (PBMCs).
Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Measured: Assessed through 8 weeks
Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)
Fitted steady-state TFV-DP concentrations after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Measured: Assessed through 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 20221 Oct 2024

First posted27 Sep 2021
Study start25 Apr 2022
Primary completion1 Oct 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
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: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05057858
Sponsor's protocol ID: STUDY00011136
Other IDs: R01AI155086
Status last verified: May 2026
First submitted: 16 Sep 2021
Last updated: 15 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Mugwanya KK, Saina M, Mugo NR, MaWhinney S, Morrow M, Schaafsma TT, Donnell D, Glidden DV, Ngure K, Brown CE, Rechkina EA, Chohan BH, Wu L, Hill E, Koome E, Akelo N, Mbaire S, Morrison SA, Kibatha M, Njeru I, Muriithi M, Coppinger C, Bushman L, Baeten JM, Anderson PL; Women Benchmark Study Team. Adherence thresholds for emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis against HIV acquisition in cisgender women: A randomized directly observed dosing study. PLoS Med. 2025 Sep 9;22(9):e1004732. doi: 10.1371/journal.pmed.1004732. eCollection 2025 Sep.
PubMed 40924774
Wu L, Saina M, Brown C, Chege D, Donnell D, Glidden DV, Ngure K, Mugo NR, Akelo N, Schaafsma T, Anderson PL, Mugwanya KK. Establishing adherence-concentration-efficacy thresholds of TDF-FTC pre-exposure prophylaxis for HIV prevention in African women: a protocol for the Women TDF-FTC Benchmark Study. Front Reprod Health. 2024 May 27;6:1325257. doi: 10.3389/frph.2024.1325257. eCollection 2024.
PubMed 38860025

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacology of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women
ClinicalTrials.gov ID: NCT05057858
Acronym / sponsor ID: STUDY00011136
Conditions: HIV Infections
Keywords: Pre-exposure Prophylaxis, HIV, Kenya
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: University of Colorado, Denver, Kenya Medical Research Institute, National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 25 Apr 2022 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 27 Sep 2021 (actual)
Results: Posted 15 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To define expected blood concentrations and dose-proportionality specific to cisgender women for tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) and peripheral blood mononuclear cells (PBMCs) using directly observed therapy of TDF/FTC at 2, 4, and 7 doses per week, representing poor, moderate, and perfect adherence, respectively.
To establish a model to predict adherence rate to TDF/FTC by level of TFV-DP observed in DBS for cisgender women. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapyt of TDF/FTC oral PrEP: 2, 4, or 7 doses/week to differentiate poor and moderate from perfect adherence.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Perfect Adherence	Experimental	Drug: co-formulated 300 mg TDF/ 200mg FTCCisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).
Moderate Adherence	Experimental	Drug: co-formulated 300 mg TDF/ 200mg FTCCisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday)
Poor Adherence	Experimental	Drug: co-formulated 300 mg TDF/ 200mg FTCCisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday)
Pregnant	Experimental	Drug: co-formulated 300 mg TDF/ 200mg FTCPregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).

Who may qualify

Ages: 18 to 30 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (22 listed)

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)

Key exclusion criteria (18 listed)

For all cisgender women
Inability to give informed consent
Positive screening HIV+ as determined by standard rapid serologic assays or suspected acute HIV infection in the opinion of the clinician. (example signs and symptoms of acute HIV infection include combinations of fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy cervical or inguinal)
Positive HBV surface antigen test at screening
Calculated creatinine clearance < 60 ml/min.

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
co-formulated 300 mg TDF/ 200mg FTCAlso: TruvadaParticipants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Drug	Moderate Adherence, Perfect Adherence, Poor Adherence, Pregnant

Primary outcome

Concentrations of Tenofovir Disphosphate (TFV-DP) Measured at Eight Weeks in Dried Blood Spots (DBS)
Time frame: Assessed at 8 weeks
TFV-DP concentrations observed in dried blood spots (DBS) after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively. Emtricitabine triphosphate FTC-TP measures are not reported, as FTC-TP was not quantifiable in DBS samples from 100%, 81%, and 21% percent of participants receiving 2, 4, and 7 doses per week, respectively.
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Steady-state in Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: Assessed through 8 weeks
Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)
Time frame: Assessed through 8 weeks
Fitted steady-state TFV-DP concentrations after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

Results and safety

Results posted to the registry on 15 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perfect Adherence	18	17
Moderate Adherence	18	16
Poor Adherence	18	16
Pregnant	18	18

Primary outcome: Concentrations of Tenofovir Disphosphate (TFV-DP) Measured at Eight Weeks in Dried Blood Spots (DBS)

Time frame: Assessed at 8 weeks. Median (Inter-Quartile Range). Unit: fmol/punch

Measure	Poor Adherence n = 16	Moderate Adherence n = 16	Perfect Adherence n = 17	Pregnant n = 17
Value	359 (266 to 464)	749 (596 to 923)	1389 (1151 to 1551)	798.9 (767.3 to 947.1)

Population analysed: Forty-nine non-pregnant participants were fully evaluable per protocol. Five non-pregnant participants did not complete the DOT period and were not fully evaluable, as described in the participant flow. These five participants contributed data up to the visit before they were censored. All 18 pregnant participants completed the DOT period. However, one pregnant participant was non-adherent to the study drug throughout the dosing period and her blood samples were excluded from analysis.

Primary outcome: Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Steady-state in Peripheral Blood Mononuclear Cells (PBMCs).

Time frame: Assessed through 8 weeks. Median (Inter-Quartile Range). Unit: fmol/10^6 cells

Measure	Poor Adherence n = 16	Moderate Adherence n = 16	Perfect Adherence n = 17	Pregnant n = 17
Observed TFV-DP concentrations	7.4 (5.6 to 14.9)	31.2 (21.5 to 39.9)	59.8 (44.7 to 74.4)	49.6 (38.3 to 60.2)
Observed FTC-TP concentrations	483 (325.2 to 812.6)	2098.9 (1444.1 to 3279.7)	5431.3 (3976.7 to 7002.6)	5586.5 (4012.7 to 5920.7)

Primary outcome: Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)

Time frame: Assessed through 8 weeks. Median (Inter-Quartile Range). Unit: fmol/punch

Measure	Poor Adherence n = 16	Moderate Adherence n = 18	Perfect Adherence n = 18	Pregnant n = 17
Value	416 (316 to 516)	832 (631 to 1033)	1457 (1106 to 1808)	895 (767 to 993)

Population analysed: Forty-nine non-pregnant participants were fully evaluable per protocol, while five did not complete the DOT period, as described in the participant flow. Three of these five contributed data appropriate for inclusion in estimation of steady state concentrations; two were excluded. All 18 pregnant participants completed the DOT period. However, one pregnant participant was non-adherent to the study drug throughout the dosing period and her blood samples were excluded from analysis.

Adverse events

Time frame: Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Poor Adherence	0 of 18 (0%)	9 of 18 (50%)	0 of 18
Moderate Adherence	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18
Perfect Adherence	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18
Pregnant	0 of 18 (0%)	17 of 18 (94.4%)	0 of 18

Limitations and caveats (from the sponsor): 1. Dosing of TDF/FTC was up to 8 weeks which is about 90% of TFV-DP steady-state in DBS. However, pharmacokinetic modeling enabled steady-state estimates. 2. Assessment of drug concentrations in PBMCs is highly dependent on cell processing and count protocols, meaning that it is difficult to compare PBMCs results across laboratories and studies. 3. The study focused on the adherence-concentration thresholds but did not explicitly evaluate the concentration-efficacy relationship.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40924774Mugwanya KK, Saina M, Mugo NR, MaWhinney S, Morrow M, Schaafsma TT, Donnell D, Glidden DV, Ngure K, Brown CE, Rechkina EA, Chohan BH, Wu L, Hill E, Koome E, Akelo N, Mbaire S, Morrison SA, Kibatha M, Njeru I, Muriithi M, Coppinger C, Bushman L, Baeten JM, Anderson PL; Women Benchmark Study Team. Adherence thresholds for emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis against HIV acquisition in cisgender women: A randomized directly observed dosing study. PLoS Med. 2025 Sep 9;22(9):e1004732. doi: 10.1371/journal.pmed.1004732. eCollection 2025 Sep.
Derived from this study: PubMed 38860025Wu L, Saina M, Brown C, Chege D, Donnell D, Glidden DV, Ngure K, Mugo NR, Akelo N, Schaafsma T, Anderson PL, Mugwanya KK. Establishing adherence-concentration-efficacy thresholds of TDF-FTC pre-exposure prophylaxis for HIV prevention in African women: a protocol for the Women TDF-FTC Benchmark Study. Front Reprod Health. 2024 May 27;6:1325257. doi: 10.3389/frph.2024.1325257. eCollection 2024.

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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.

Kenneth K Mugwanya, MBChB, MS, PhD principal investigator

University of Washington

Peter L Anderson, PharmD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing co-formulated 300 mg TDF/ 200mg FTC in people with HIV Infections, run by University of Washington at 1 site in Kenya.

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 22 inclusion and 18 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of Tenofovir Disphosphate (TFV-DP) Measured at Eight Weeks in Dried Blood Spots (DBS) (time frame: Assessed at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05057858, which also lists 2 linked publications.

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 15 Jun 2026.