Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes

Bardon, Ashley; Dorward, Jienchi; Sookrajh, Yukteshwar; Sayed, Fathima; Quame-Amaglo, Justice; Pillay, Cheryl.; Feutz, Erika; Ngobese, Hope; Simoni, Jane M.; Cressey, Tim R.; Gandhi, Monica; Lessells, Richard; Moodley, Pravi; Naicker, Nivashnee; Naidoo, Kogieleum; Thomas, Katherine K.; Celum, Connie; Karim, Salim Safurdeen. Abdool; Garrett, Nigel; Drain, Paul K.

doi:10.1136/bmjopen-2021-050116

Cited by 10 publications

(11 citation statements)

References 39 publications

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“…It could be expected that drug exposure testing may yield similar results as a screening test for InSTI resistance during treatment with DTG, given its high genetic barrier to resistance. This hypothesis is currently being tested in one RCT, which evaluates an intensified monitoring intervention similar to the strategy described in this trial, combined with point-of-care viral load monitoring, in patients on DTG-based ART [29].…”

Section: Discussionmentioning

confidence: 99%

A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch

Hermans

Heine²,

Schuurman

et al. 2022

Aids

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Introduction:Standard-of-care antiretroviral treatment (ART) monitoring in low and middle-income countries consists of annual determination of HIV-RNA viral load with confirmatory viral load testing in case of viral rebound. We evaluated an intensified monitoring strategy of three-monthly viral load testing with additional drug exposure and drug resistance testing in case of viral rebound.Methods:We performed an open-label randomized controlled trial (RCT) at a rural South African healthcare clinic, enrolling adults already receiving or newly initiating first-line ART. During 96 weeks follow-up, intervention participants received three-monthly viral load testing and sequential point-of-care drug exposure testing and DBS-based drug resistance testing in case of rebound above 1000 copies/ml. Control participants received standard-of-care monitoring according to the WHO guidelines.Results:Five hundred one participants were included, of whom 416 (83.0%) were randomized at 24 weeks. Four hundred one participants were available for intention-to-treat analysis. Viral rebound occurred in 9.0% (18/199) of intervention participants and in 11.9% (24/202) of controls (P = 0.445). Time to detection of rebound was 375 days [interquartile range (IQR): 348–515] in intervention participants and 360 days [IQR: 338–464] in controls [hazard ratio: 0.88 (95% confidence interval (95% CI): 0.46–1.66]; P = 0.683]. Duration of viral rebound was 87 days [IQR: 70–110] in intervention participants and 101 days [IQR: 78–213] in controls (P = 0.423). In the control arm, three patients with confirmed failure were switched to second-line ART. In the intervention arm, of three patients with confirmed failure, switch could initially be avoided in two cases.Conclusion:Three-monthly viral load testing did not significantly reduce the duration of viraemia when compared with standard-of-care annual viral load testing, providing randomized trial evidence in support of annual viral load monitoring.

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Section: Discussionmentioning

confidence: 99%

A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch

Hermans

Heine²,

Schuurman

et al. 2022

Aids

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“…Across CCMDD-eligible and CCMDD-ineligible participants, there were no major differences in sociodemographic characteristics, travel time to clinic, HIV disclosure, and behaviors that could affect adherence to ART (Table 1). Among CCMDD-eligible participants, the median age of those participating in the CCMDD program was 30 years [IQR: 26-37] and 68% (n = 79) were female, while the median age of those not participating in the CCMDD program was 32 years [IQR: [27][28][29][30][31][32][33][34][35][36][37][38]] and 71% (n = 20) were female (Table 1). Almost half (45%; n = 52) of the CCMDD program participants did not pass secondary school (Table 1).…”

Section: Participant Characteristicsmentioning

confidence: 99%

Delivery of Community-based Antiretroviral Therapy to Maintain Viral Suppression and Retention in Care in South Africa

Wang

Violette

Dorward

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background:To determine whether the Centralized Chronic Medication Dispensing and Distribution (CCMDD) program in South Africa's differentiated ART delivery model affects clinical outcomes, we assessed viral load (VL) suppression and retention in care between patients participating in the program and those receiving the clinic-based standard of care.Methods:Clinically stable people living with HIV (PLHIV) eligible for differentiated care were referred to the national CCMDD program and followed up for up to 6 months. In this secondary analysis of trial cohort data, we estimated the association between routine patient participation in the CCMDD program and their clinical outcomes of viral suppression (<200 copies/mL) and retention in care.Results:Among 390 PLHIV, 236 (61%) were assessed for CCMDD eligibility; 144 (37%) were eligible, and 116 (30%) participated in the CCMDD program. Participants obtained their ART in a timely manner at 93% (265/286) of CCMDD visits. VL suppression and retention in care was very similar among CCMDD-eligible patients who participated in the program compared with patients who did not participate in the program (aRR: 1.03; 95% CI: 0.94–1.12). VL suppression alone (aRR: 1.02; 95% CI: 0.97–1.08) and retention in care alone (aRR: 1.03; 95% CI: 0.95–1.12) were also similar between CCMDD-eligible PLHIV who participated in the program and those who did not.Conclusion:The CCMDD program successfully facilitated differentiated care among clinically stable participants. PLHIV participating in the CCMDD program maintained a high proportion of viral suppression and retention in care, indicating that community-based ART delivery model did not negatively affect their HIV care outcomes.

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“…While several clinical trials are planned or underway to evaluate the clinical impact of point-ofcare urine TFV assays on HIV treatment outcomes [11,12,13], more observational data is needed to further evaluate diagnostic accuracy, and associations between point-of-care urine TFV results with HIV viraemia and drug resistance. In the context of the global rollout of the fixed-dose combination of tenofovir-lamivudine-dolutegravir (TLD), objective measures of adherence may be even more useful.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy of a point-of-care urine tenofovir assay, and associations with HIV viraemia and drug resistance among people receiving dolutegravir and efavirenz-based antiretroviral therapy

Dorward

Lessells

Govender

et al. 2023

Preprint

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Introduction: Novel point-of-care assays which measure urine tenofovir (TFV) concentrations may have a role in improving adherence monitoring for people living with HIV (PLHIV) receiving antiretroviral therapy (ART). However, further studies of their diagnostic accuracy, and whether results are associated with viraemia and drug resistance, are needed to guide their use, particularly in the context of the global dolutegravir rollout. Methods: We conducted a cross-sectional evaluation among PLHIV receiving first-line ART containing tenofovir disoproxil fumarate (TDF). We calculated the diagnostic accuracy of the Abbott point-of-care assay to detect urine TFV measured by liquid chromatography and mass spectrometry. We evaluated the association between point-of-care urine TFV results and self-reported adherence, viraemia ≥1000 copies/mL, and HIV drug resistance, among people receiving either efavirenz or dolutegravir-based ART. Results: Among 124 participants, 55% were women, median age was 39 (IQR 34-45) years. 74 (59.7%) were receiving efavirenz, and 50 (40.3%) dolutegravir. Sensitivity and specificity to detect urine TFV ≥1500ng/mL were 96.1% (95%CI 90.0-98.8) and 95.2% (75.3-100.0) respectively. Urine TFV results were associated with short (p<0.001) and medium term (p=0.036) self-reported adherence. Overall, 44/124 (35.5%) had viraemia, which was associated with undetectable TFV in those receiving efavirenz (OR 6.01, 1.27-39.0, p=0.014) and dolutegravir (OR 25.7, 4.20-294.8, p<0.001). However, in those with viraemia while receiving efavirenz, 8/27 (29.6%) had undetectable urine TFV, compared to 11/17 (64.7%) of those receiving dolutegravir. Drug resistance was detected in 23/27 (85.2%) of those receiving efavirenz and only 1/16 (6.3%) of those receiving dolutegravir. There was no association between urine TFV results and drug resistance. Conclusions: Among PLHIV receiving ART, a rapid urine TFV assay can be used to accurately monitor urine TFV levels. Undetectable point-of-care urine TFV results were associated with viraemia, particularly among people receiving dolutegravir. Trial registration: Pan-African Clinical Trials Registry: PACTR202001785886049.

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Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes

Cited by 10 publications

References 39 publications

A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch

A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch

Delivery of Community-based Antiretroviral Therapy to Maintain Viral Suppression and Retention in Care in South Africa

Diagnostic accuracy of a point-of-care urine tenofovir assay, and associations with HIV viraemia and drug resistance among people receiving dolutegravir and efavirenz-based antiretroviral therapy

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