Point-of-care Urine Monitoring of Adherence (PUMA): Testing a Real-Time Urine Assay of Tenofovir in PrEP

Phase 4

• Conditions: HIV/AIDS

• Registration Number: PACTR202003901399017
• Lead Sponsor: niversity of California San Fransisco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

The eligibility criteria for this study are the following:
•Female
•Adult, age =18 years old
•HIV-1 uninfected based on a negative HIV-1 rapid test
•Not currently enrolled in an HIV-1 prevention clinical trial
•Not currently in a serodiscordant relationship
•Already taking PrEP and will be enrolled at the 3-month follow-up visit following PrEP initiation
•Willing to be randomized to point-of-care tenofovir drug testing
•Willing/able to provide informed consent to participate in the study
•No contraindication to use of TDF or FTC
•Note: Women who are pregnant at screening/enrollment are still eligible

Exclusion Criteria

Not willing and/or not able to provide written informed consent to participate in the study
In a HIV serodiscordant relationship
Not willing to be randomized to either arms of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified