Infectious Disease · Medical Literature
A Urine Tenofovir Point-of-Care Assay Facilitates Positive Antiretroviral Therapy Adherence Discussions Among People Living With HIV and Healthcare Providers-A Mixed-Methods Evaluation in Cape Town, South Africa.
Abstract
In South Africa, antiretroviral therapy adherence monitoring relies on self-reported adherence, which is prone to recall error, and only verified annually during blood viral load measurement. A novel urine tenofovir rapid assay (UTRA) is a low-cost point-of-care adherence support tool for people living with HIV (PLHIV). Nested in an effectiveness randomized trial, we aimed to understand the relative acceptability of adherence support experiences among PLHIV receiving the UTRA point-of-care adherence intervention versus standard of care. All trial participants (n = 199) completed a brief, repeat-measures, quantitative acceptability questionnaire at months 3, 6 and 12. We also conducted longitudinal in-depth interviews with 25 PLHIV with three interactions per participant over 52 weeks-a total of 75 interviews. Interviewed PLHIV were purposively sampled for balance by arm, diversity in age and gender, rich-case sampling, and saturation. We also conducted once-off in-depth interviews with five healthcare providers administering the UTRA intervention. Data were collected between May 2022 and June 2024. Qualitative data analysis involved descriptive summaries of key emergent themes with illustrative case examples augmented by descriptive statistics from the questionnaires. Participants in the intervention arm reported that being tested and informed about their adherence levels in real-time served as a reminder to take treatment consistently. The UTRA facilitated conversations between PLHIV and healthcare providers on how to overcome barriers to adherence. Participants in the control arm reported that they relied on relatives for adherence support and accountability because there is limited time for adherence discussions with healthcare providers. Healthcare providers reported that providing adherence counselling to PLHIV receiving standard of care was challenging because they relied on voluntary disclosure of adherence interruptions. PLHIV in the intervention arm reported more positive experiences of adherence support compared to those in the control arm, regardless of their adherence practices. A point-of-care adherence tool like the UTRA provides a much-needed platform for PLHIV and healthcare providers to discuss adherence practices and challenges. PLHIV preferred this style of adherence support compared to the standard of care.
Clinical relevance
Among people living with HIV (PLHIV) in Cape Town, South Africa, is the Urine Tenofovir Rapid Assay (UTRA) point-of-care intervention more acceptable to patients and healthcare providers as an ART adherence support tool compared with standard-of-care self-reported adherence monitoring? __SNAPSHOT__ {"studyDesign":"Mixed-methods evaluation nested within an effectiveness randomized controlled trial; includes a repeat-measures quantitative acceptability questionnaire component and a longitudinal qualitative in-depth interview component with purposive sampling","setting":"Primary healthcare setting, Cape Town, South Africa (public sector ART clinic); data collected May 2022 – June 2024","sampleSize":"Quantitative component: n=199 (all trial participants); Qualitative PLHIV component: n=25 (75 interviews over 52 weeks, 3 per participant); Healthcare provider component: n=5 (once-off in-depth interviews)","population":"PLHIV receiving TDF-containing ART enrolled in a parent effectiveness RCT; purposive sampling of interview sub-cohort aimed for balance by randomization arm, age, gender, rich-case sampling, and thematic saturation; specific inclusion/exclusion criteria not reported in the abstract","intervention":"UTRA point-of-care adherence intervention: qualitative urine tenofovir lateral flow assay providing a real-time (24–48-hour adherence window) result at the point of care, paired with immediate data-informed adherence counseling by study staff","comparator":"Standard of care: self-reported adherence monitoring with adherence support triggered by elevated viral load per South African National Department of Health guidelines","primaryOutcome":"Relative acceptability of adherence support experiences between the UTRA intervention arm and standard-of-care arm, assessed via a brief repeat-measures quantitative acceptability questionnaire at months 3, 6, and 12, and via longitudinal in-depth interviews at three timepoints over 52 weeks","followUp":"52 weeks (12 months)","fundingSource":"Not reported in the abstract; the parent RCT (NCT05333679) and related work from this group have received NIH/NIAID funding (R01AI152119, R01AI143340); the OraSure/SureQuick assay was used in related studies by this group, with one collaborator previously affiliated with OraSure Technologies"}
Key findings
The full article results are not available from the abstract alone; the following reflects what is inferable from the abstract and title. The study's central reported conclusion—reflected in the title—is that the UTRA point-of-care assay facilitated positive ART adherence discussions between PLHIV and healthcare providers. The quantitative acceptability questionnaire was administered to all 199 trial participants at months 3, 6, and 12; numerical scores, between-arm differences, confidence intervals, and p-values are not reported in the abstract. The qualitative component yielded descriptive summaries of key emergent themes from 75 longitudinal in-depth interviews with 25 PLHIV (three interactions per participant) and 5 once-off provider interviews; specific themes, sub-themes, and their distribution are not reported in the abstract. The parent RCT (van Zyl et al., CID, 2025; n=200, participants with prior virologic failure) found that UTRA-enhanced adherence support was not associated with a statistically significant improvement in viral suppression at 12 months (74% vs. 64%, p=0.2) but was associated with significantly higher TFV-diphosphate concentrations in dried blood spots (median 884 vs. 598 fmol/3mm DBS punch, p<0.01), suggesting improved long-term drug exposure. NNT and NNH for the acceptability outcomes of the current mixed-methods study are not calculable from the abstract. No adverse events attributable to the UTRA intervention are reported in the abstract.
Practice implications
This mixed-methods evaluation establishes that PLHIV and healthcare providers perceived the UTRA point-of-care adherence intervention favorably and that the assay facilitated more positive adherence-focused clinical discussions compared with standard self-reported monitoring—a meaningful implementation science finding, given that self-reported adherence is well-established to overestimate true adherence and is only verified annually via viral load in South Africa. The study did not establish improvements in virological outcomes (addressed in the companion RCT by van Zyl et al.), nor did it establish causation between UTRA-facilitated discussions and sustained behavioral adherence change over time. The findings apply most directly to PLHIV already enrolled in ART care at urban public sector primary healthcare clinics in Cape Town receiving TDF-containing regimens; generalizability to rural settings, adolescents, pregnant women, people on TAF-based regimens, or other African healthcare contexts is not established. The provider sample (n=5) is very small, limiting confidence in provider-level conclusions. Because only an abstract is available, the specific qualitative themes, quantitative acceptability scores and between-arm differences, analytic framework used, and the degree to which mixed-methods integration informed conclusions cannot be independently assessed. The UTRA's technical characteristics (qualitative result, 24–48-hour adherence window, ~98% sensitivity for dose taken in past 24 hours at a threshold of 1,500 ng/mL) are well-validated in prior studies; acceptability and implementation feasibility are the incremental contribution of this paper. Taken together with the companion RCT, the evidence suggests the UTRA is acceptable and improves drug exposure but has not yet demonstrated a statistically significant viral suppression benefit in a randomized trial. __LIMITATIONS__ 1. Abstract-only access: specific quantitative results, effect sizes, confidence intervals, and qualitative theme details cannot be verified or fully assessed. 2. Small provider sample (n=5 once-off interviews) substantially limits the generalizability of provider-perspective findings. 3. Purposive qualitative sampling, while methodologically appropriate, does not permit frequency-based generalization; thematic saturation in a sample of 25 PLHIV may not capture minority perspectives. 4. Longitudinal qualitative design over 52 weeks is methodologically rigorous but subject to participant attrition and social desirability bias, particularly for interviews about adherence. 5. The quantitative acceptability questionnaire instrument is described as 'brief' but is not validated against a named scale in the abstract, and between-arm statistical comparisons and p-values are not reported. 6. Generalizability is restricted: urban Cape Town public sector setting, TDF-containing regimens only (TAF not available in South African public sector), and participants enrolled in a research trial, which may inflate acceptability relative to routine care. 6. The parent RCT showed no statistically significant improvement in viral suppression (p=0.2), suggesting that high acceptability alone does not translate to virological benefit in the short term. 7. Potential Hawthorne effect: participation in repeated in-depth interviews over 52 weeks may itself influence adherence behavior and acceptability perceptions. 8. Funding source not reported in the abstract; conflicts of interest cannot be assessed from the abstract. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ The UTRA point-of-care urine tenofovir assay was reported as acceptable to PLHIV and healthcare providers in a Cape Town primary care setting and facilitated more positive adherence-focused clinical discussions than standard self-reported monitoring; however, specific acceptability scores and between-arm statistical comparisons are not reported in the abstract. The companion randomized trial demonstrated improved long-term TDF drug exposure with UTRA-enhanced counseling but no statistically significant improvement in viral suppression at 12 months, indicating that high acceptability does not yet translate to proven virological benefit. Clinicians and program planners in LMIC settings may find this evidence supportive of integrating UTRA into adherence support workflows, but additional larger trials confirming virological impact are needed before widespread implementation is recommended.