Trial Outcomes & Findings for Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP (NCT NCT03935464)

Last Updated: 2025-10-27

Results Overview

Primary outcome is number of participants in each arm with detectable hair concentrations of Tenofovir indicating long-term adherence at 12 months (undetectable levels defined long-term non-adherence), as well as urine concentrations of Tenofovir at 12 months as a short-term adherence metric.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 months for each participant from the time of enrollment

Results posted on

2025-10-27

Participant Flow

The study was conducted at the Kenya Medical Research Institute (KEMRI) Partners in Health and Research Development (PHRD) clinical research center at Thika. This center is associated with 5 five community sites from which participants were recruited for the study including surrounding voluntary counselling and testing centers, churches, and community organizations. Participants on PrEP for the last 3 months were recruited. Study began recruiting from March 1, 2021.

105 women were assessed for eligibility and 5 were found ineligible because 4 were unavailable for study procedures and 1 was underage. 100 participants were enrolled and 49 were assigned to urine test counselling and 51 assigned to standard of care procedures.

Participant milestones

Participant milestones
Measure	Intervention Arm POC adherence testing by a urine TFV assay with feedback PUMA: 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.	Standard of Care Follow Kenya's PrEP guidelines on standard adherence counselling
Overall Study STARTED	49	51
Overall Study COMPLETED	49	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=49 Participants POC adherence testing by a urine TFV assay with feedback PUMA: 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.	Standard of Care n=51 Participants Follow Kenya's PrEP guidelines on standard adherence counselling	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.3 Years STANDARD_DEVIATION 10.6 • n=5 Participants	33.8 Years STANDARD_DEVIATION 8.2 • n=7 Participants	33.6 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Kenya	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months for each participant from the time of enrollment

Population: Adult women not in sero-discordant partnerships were enrolled 3 months after PrEP initiation at the Kenya Medical Research Institute.

Outcome measures

Outcome measures
Measure	PUMA Intervention Arm n=49 Participants Point-of-care (POC) adherence testing by a urine TFV assay with feedback 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 along with provision of standard adherence counseling.	PUMA Standard of Care n=51 Participants Follow Kenya's PrEP guidelines on standard adherence counselling
Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir. Detectable Tenofovir in hair indicating long-term adherence	33 Participants	26 Participants
Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir. Detectable Tenofovir in urine indicating short-term adherence	31 Participants	19 Participants

SECONDARY outcome

Timeframe: Completed after the participants' 12-month follow-up visit

Population: Healthcare providers who provide PrEP

Themes among PrEP providers about feasibility of providing urine assay feedback to study participants on PrEP. The In-depth interviews and focus group discussions were cross-sectional.

Outcome measures

Outcome measures
Measure	PUMA Intervention Arm n=8 Participants Point-of-care (POC) adherence testing by a urine TFV assay with feedback 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 along with provision of standard adherence counseling.	PUMA Standard of Care Follow Kenya's PrEP guidelines on standard adherence counselling
Feasibility Among Healthcare Providers of Providing Test Feedback to Participants Easy to Use	6 Participants	—
Feasibility Among Healthcare Providers of Providing Test Feedback to Participants Feasible within routine care	8 Participants	—
Feasibility Among Healthcare Providers of Providing Test Feedback to Participants Concerned about added workload	3 Participants	—

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Monica Gandhi

University of California San Francisco

Phone: 415 260 6709

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place