Adherence and Clinical Correlates in Persons With HIV on TAF (ACT)

May 4, 2026 updated by: University of Colorado, Denver
This is an observational, 48-week, prospective study of PWH treated with TAF in which the investigators will compare TFV-DP concentrations in DBS in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict future viremia. To accomplish this, the investigators will approach PWH currently taking TAF (which is being prescribed by a primary care physician) and who present to the clinic for regular HIV care and HIV VL assessment. Participants will complete up to 3 visits (at least 2 weeks apart) during the 48-week study follow-up period.

Study Overview

Status

Completed

Conditions

Detailed Description

Antiretroviral (ARV) drug exposure is directly linked to individual host factors, including age, weight, diet, and genetics. However, the main factor influencing long-term drug exposure is drug adherence. Adherence is a strong predictor of HIV treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. There is no gold-standard measure to monitor ARV exposure and adherence that has been implemented in clinical practice. Tenofovir diphosphate (TFV-DP), the phosphorylated anabolite of tenofovir (TFV), has distinct pharmacological characteristics that make it an ideal candidate for drug adherence and exposure monitoring. The long half-life of TFV-DP (~17 days) in red blood cells (RBC), which are abundant in dried blood spots (DBS) are properties that make it well suited for monitoring average TFV exposure over time both from tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). TFV-DP in DBS in persons with HIV (PWH) on TDF has been associated with viral suppression and is predictive of future viremia, even in patient who are virologically-suppressed. However, data on TFV-DP in DBS from TAF are lacking. To address this gap, this study will assess the association of TFV-DP in DBS from PWH on TAF with clinically-relevant virologic outcomes.

Study Type

Observational

Enrollment (Actual)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We propose a 48-week observational study at the University of Colorado Hospital Infectious Diseases Group Practice (UCH-IDGP) in PWH taking TAF. Its goals are to define the association between TFV-DP in DBS and viral suppression and future viremia.

Description

Inclusion Criteria:

  1. Females or males with HIV (≥18 years), able to give informed consent and comply with study procedures who are having a blood draw as part of their regular clinical care.
  2. Being prescribed TAF-based ART >= 3 months.

Exclusion Criteria:

1. For females, active pregnancy or intent to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated with odds of HIV viral suppression at all study visits
Time Frame: 48 weeks
HIV viral load, binary cutoff at assay level of detection (<20 copies/mL vs >= 20 copies/mL); reference group lowest adherence category for TFV-DP; adjusted odds ratio calculated using generalized estimated equations; concentration cutoffs established in prior research of healthy volunteers and persons with HIV (PWH)
48 weeks
Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated with odds of HIV viremia at next study visit
Time Frame: 48 weeks
HIV viral load, binary cutoff at assay level of detection (<20 copies/mL vs >= 20 copies/mL); reference group lowest adherence category for TFV-DP; adjusted odds ratio calculated using generalized estimated equations; concentration cutoffs established in prior research of healthy volunteers and persons with HIV (PWH)
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Peter L Anderson, PharmD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Actual)

May 4, 2026

Study Completion (Actual)

May 4, 2026

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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