An interventional study of UTRA and UTRA feedback in Risk Reduction, sponsored by University of California, San Francisco. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
ART is given to people living with HIV in order to suppress the virus, resulting in improved health for the individual and decreased transmission of the virus to others. Success of ART is dependent on adherence. Currently, adherence is assessed by asking patients directly and then confirming with a viral load test, which is expensive and is often only done when the viral load is already raised. Therefore there is a need to find a method to detect problems with adherence early before the viral load rises.
A urine-based test was recently developed, called UTRA (urine tenofovir rapid assay). This test can give clinic staff immediate results about a person's adherence to the antiretroviral medication Tenofovir (TDF). The study will compare the results of this urine test to drug levels found in blood, self-reported adherence and pharmacy collection records to see if this test can be used as part of routine care in ART clinics. If the test is effective it would allow clinic staff to identify people with adherence difficulties early and give them the necessary support before their viral load rises.
This is a randomised study, recruiting 200 people taking TDF-based ART. Participants will be randomised 1:1 to intervention versus standard enhanced adherence counselling. Intervention participants will receive an adherence support package informed by feedback from the urine-based test. The investigators will assess the impact of the adherence test on VL suppression rates in each arm (without necessitating a regimen switch) at 12 months after enrolment. Enrolling participants with adherence challenges increases efficiency and mirrors the population requiring adherence support in our setting.
The UTRA device used for this study has received a FDA Non-Significant Risk (NSR) designation and is IDE exempt.
FEASIBILITY:
The investigators will track retention in the study among participants in each arm, missed visits, and the number of urine assessments performed in the intervention arm.
ACCEPTABILITY:
All participants enrolled will also complete a standardised questionnaire about the acceptability of the adherence support they received. This measure of acceptability will be assessed as a secondary outcome by arm, along with socio-demographics profiles associated with low/high acceptability described within arm.
QUALITATIVE PROCEDURES:
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's enrollment of 200 is close to the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POC adherence testing by a urine TFV assay with feedback
Device: UTRA · Behavioral: UTRA feedback
Standard enhanced adherence counselling, SA Department of Health, March 2020
Collect urine on intervention participants and screen for presence of TFV.
Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml
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
Time frame: 12 months
Number of Participants Retained in Care
Follow 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
Time frame: 12 months
Viral Suppression (<50 Copies/mL)
Assess 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
Time frame: 6 months
The Proportion of Participants Indicating "Strongly Agree" or "Agree" Averaged Across 10 Items, Each Using a Five-point Likert Scale to Measure Aspects of the Adherence Support Intervention (i.e., by Arm: UTRA-informed or Standard of Care)
The 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.
Time frame: 12 months
| Milestone | Intervention | Standard of Care |
|---|---|---|
| Started | 100 | 100 |
| Completed | 80 | 75 |
| Not completed | 20 | 25 |
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
| Participants | Intervention | Standard of Care |
|---|---|---|
| Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml | 59 | 48 |
Follow 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
| participants | Intervention | Standard of Care |
|---|---|---|
| Number of Participants Retained in Care | 59 | 48 |
Assess 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
Results for this outcome have not been posted.
The 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.
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 1/80 (1.3%) | 1/80 (1.3%) | 0/80 (0%) |
| Standard of Care | 0/75 (0%) | 0/75 (0%) | 0/75 (0%) |
| Event | Intervention | Standard of Care |
|---|---|---|
| DeathGeneral disorders | 1/80 | 0/75 |
| Age, Categorical(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 99 | 100 | 199 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(Years) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Mean | 43.6 ± 10.4 | 42.9 ± 9.87 | 43.5 ± 10.2 |
| Sex: Female, Male(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Female | 71 | 66 | 137 |
| Male | 29 | 34 | 63 |
| Race (NIH/OMB)(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 100 | 100 | 200 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| South Africa | 100 | 100 | 200 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 48 months from start of study
Access criteria: Investigators conducting PrEP research
Ran from Mar 2022 to primary completion in Jun 2025, 39 months.
Results were first posted in Apr 2026, 9 months after primary completion.
Of 167 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's 39 months is above that.
Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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