Trial Outcomes & Findings for Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) (NCT NCT05333679)
NCT ID: NCT05333679
Last Updated: 2026-04-28
Results Overview
Assess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Plasma will be stored an enrolment, month 6 and month 12 for viral load assay completion after the study. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures
COMPLETED
NA
200 participants
12 months
2026-04-28
Participant Flow
Participant milestones
| Measure |
Intervention
POC adherence testing by a urine TFV assay with feedback
UTRA: Collect urine on intervention participants and screen for presence of TFV.
UTRA feedback: Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
|
Standard of Care
Standard enhanced adherence counselling, SA Department of Health, March 2020
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
80
|
75
|
|
Overall Study
NOT COMPLETED
|
20
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The difference in numbers analyzed is loss to follow-up.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=100 Participants
Standard enhanced adherence counselling, SA Department of Health, March 2020
|
Total
n=200 Participants
Total of all reporting groups
|
Intervention
n=100 Participants
POC adherence testing by a urine TFV assay with feedback
UTRA: Collect urine on intervention participants and screen for presence of TFV.
UTRA feedback: Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=24 Participants
|
199 Participants
n=23 Participants
|
99 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=9 Participants
|
|
Age, Continuous
|
42.9 Years
STANDARD_DEVIATION 9.87 • n=24 Participants
|
43.5 Years
STANDARD_DEVIATION 10.2 • n=23 Participants
|
43.6 Years
STANDARD_DEVIATION 10.4 • n=9 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=24 Participants
|
137 Participants
n=23 Participants
|
71 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=24 Participants
|
63 Participants
n=23 Participants
|
29 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Race (NIH/OMB)
Black or African American
|
100 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
200 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
100 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=23 Participants • The difference in numbers analyzed is loss to follow-up.
|
0 Participants
n=9 Participants • The difference in numbers analyzed is loss to follow-up.
|
|
Region of Enrollment
South Africa
|
100 participants
n=24 Participants
|
200 participants
n=23 Participants
|
100 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAssess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Plasma will be stored an enrolment, month 6 and month 12 for viral load assay completion after the study. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures
Outcome measures
| Measure |
Intervention
n=80 Participants
POC adherence testing by a urine TFV assay with feedback
UTRA: Collect urine on intervention participants and screen for presence of TFV.
UTRA feedback: Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
|
Standard of Care
n=75 Participants
Standard enhanced adherence counselling, SA Department of Health, March 2020
|
|---|---|---|
|
Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml
|
59 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 12 monthsFollow up visits will occur in 12-week increments post-enrolment: at month 3, month 6, month 9 and month 12; and will be synchronized wherever possible with routine clinic visits. Visit windows will be continuous, with each window extending to 6 weeks before and 6 weeks after the visit target date. A visit will be considered missed if the participant does not attend during the 12-week visit window
Outcome measures
| Measure |
Intervention
n=80 Participants
POC adherence testing by a urine TFV assay with feedback
UTRA: Collect urine on intervention participants and screen for presence of TFV.
UTRA feedback: Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
|
Standard of Care
n=75 Participants
Standard enhanced adherence counselling, SA Department of Health, March 2020
|
|---|---|---|
|
Number of Participants Retained in Care
|
59 participants
|
48 participants
|
SECONDARY outcome
Timeframe: 6 monthsAssess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsThe proportion of participants indicating "strongly agree" or "agree" averaged across 10 items, each item using a five-point Likert scale to measure aspects of acceptability of the adherence support intervention (i.e., by arm: UTRA-informed or standard of care), at month 12. Responses to the Likert scale range from "Strongly agree" to "Strongly disagree". Aspects of acceptability include domains on: support from health workers, time given by health workers to discuss the patients' treatment, patient perceptions of feeling informed about their adherence, feelings of surveillance (-vely scored), and self-satisfactions with adherence.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Standard of Care
Serious adverse events
| Measure |
Intervention
n=80 participants at risk
POC adherence testing by a urine TFV assay with feedback
UTRA: Collect urine on intervention participants and screen for presence of TFV.
UTRA feedback: Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
|
Standard of Care
n=75 participants at risk
Standard enhanced adherence counselling, SA Department of Health, March 2020
|
|---|---|---|
|
General disorders
Death
|
1.2%
1/80 • Number of events 1 • 1 year
|
0.00%
0/75 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place