At a glance
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Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay
In Brief
A clinical study evaluating PUMA for Risk Reduction. Completed, enrolled 100 participants across 1 site.
Detailed Summary
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to the interpretation of the PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. We now want to test the acceptability, feasibility and preliminary impact of monitoring adherence in real-time using this novel POC assay with adherence feedback provided to the patient with supportive messaging (versus standard of care adherence counseling).
Study Details
Timeline
Interventions
Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their adherence with provision of standard adherence counseling.