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

Pilot trial to examine the feasibility, acceptability, and impact on longer-term adherence of an intervention using a new urine-based tenofovir adherence assay

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202003901399017

Enrollment

100

Registered

2020-03-26

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Point of care Urine Assay of Tenofovir in PrEP

Standard of Care adherence counselling

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Trial outcomes will be acceptability to participants, feasibility for healthcare providers, and long-term metrics of PrEP adherence as assessed via TFV concentrations in hair samples.	—

Secondary

Measure	Time frame
HIV-1 incidence will be measured but is expected to be low (0.2% per year in the Partners Demonstration Project, and 0% for those taking PrEP) and the study would need to be considerably larger to be powered to assess incident HIV-1 (and unnecessary, given the established relationship between PrEP adherence and efficacy). We will assess genotypic HIV-1 resistance among any seroconverters and provide that information to the healthcare providers assuming responsibility for the patient’s routine HIV care.	—

Measure

Time frame

HIV-1 incidence will be measured but is expected to be low (0.2% per year in the Partners Demonstration Project, and 0% for those taking PrEP) and the study would need to be considerably larger to be powered to assess incident HIV-1 (and unnecessary, given the established relationship between PrEP adherence and efficacy). We will assess genotypic HIV-1 resistance among any seroconverters and provide that information to the healthcare providers assuming responsibility for the patient’s routine HIV care.

—

Countries

Kenya

Contacts

Public ContactPeter Mogere

Study Coordinator

patandi@pipsthika.org0707177811

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026