Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study

Dorward, Jienchi; Garrett, Nigel; Quame-Amaglo, Justice; Samsunder, Natasha; Ngobese, Hope; Ngomane, Noluthando; Moodley, Prashini; Mlisana, Koleka; Schaafsma, Torin T; Donnell, Deborah; Barnabas, Ruanne V.; Naidoo, Kogieleum; Karim, Salim Safurdeen. Abdool; Celum, Connie; Drain, Paul K.

doi:10.1136/bmjopen-2017-017507

Cited by 21 publications

(28 citation statements)

References 43 publications

(26 reference statements)

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“…Our costing analysis was conducted within the Simplifying HIV TREAtment and Monitoring (STREAM) study, a randomized clinical trial of POC HIV VL monitoring in Durban, South Africa. [20] In STREAM, adult PLHIV who were stable on ART were randomized to receive either 1) POC HIV VL, CD4 count and creatinine monitoring and potential task-shifting to enrolled nurses, or 2) routine laboratory-based monitoring and standard South African HIV care. The STREAM trial was conducted at the CAPRISA eThekwini Research Clinic and the Prince Cyril Zulu Communicable Disease Centre, an urban government clinic providing primary care sexual health, HIV, and TB services.…”

Section: Methodsmentioning

confidence: 99%

Comparative cost analysis of point-of-care versus laboratory-based testing to initiate and monitor HIV treatment in South Africa

et al. 2019

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BackgroundThe number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries has been rapidly expanding, placing an increasing burden on laboratories. Promising new point-of-care (POC) test have the potential to reduce laboratory workloads, but the implementation cost is uncertain. We sought to estimate the costs of decentralized POC testing compared to centralized laboratory testing for PLHIV initiating treatment in South Africa.MethodsWe conducted a microcosting analyses comparing clinic-based POC testing to centralized laboratory testing for HIV viral load, creatinine, and CD4 count monitoring. We completed time-and-motion studies to assess staff time for sample collection and processing. Instrument costs were estimated assuming five-year lifespans and we applied a 3% annual discount rate. Total costs and cost per patient were estimated over a five-year period: the first year of ART initiation and four years of routine HIV monitoring, following World Health Organization ART monitoring guidelines.ResultsWe estimated that per-patient costs of POC HIV viral load, CD4, and creatinine tests were USD $25, $11, and $9, respectively, assuming a clinic volume of 50 patients initiated per month. At centralized laboratories, per-patient costs of POC HIV viral load, CD4, and creatinine tests were USD $26, $6, $3. Total monitoring costs of all testing over a 5-year period was $45 higher for POC testing compared to centralized laboratory testing ($210 vs $166).ConclusionsPOC testing for HIV care and treatment can be feasibly implemented within clinics in South Africa, particularly those with larger patient volumes. POC HIV viral load costs are similar to lab-based testing while CD4 count and creatinine testing are more costly as POC tests. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses of POC testing.

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Section: Methodsmentioning

confidence: 99%

Comparative cost analysis of point-of-care versus laboratory-based testing to initiate and monitor HIV treatment in South Africa

et al. 2019

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“…Clinical trials of POC viral load testing may facilitate task shifting to nurses and referral into differentiated care programs (Table 3) (47,48,(188)(189)(190). In one study, integrated POC monitoring using POC CD4 count (Pima), POC creatinine, and POC HIV viral load (Xpert HIV-1) is being evaluated to rapidly identify stable patients who can be seen by an enrolled/auxiliary nurse every 2 months and then be down-referred to a community ART delivery program, in which they are seen by a nurse every 6 months ( Fig.…”

Section: Looking Ahead: the Role Of Poc Hiv Viral Load Testing Withinmentioning

confidence: 99%

“…In one study, integrated POC monitoring using POC CD4 count (Pima), POC creatinine, and POC HIV viral load (Xpert HIV-1) is being evaluated to rapidly identify stable patients who can be seen by an enrolled/auxiliary nurse every 2 months and then be down-referred to a community ART delivery program, in which they are seen by a nurse every 6 months ( Fig. 4) (188). The primary outcome is viral suppression and retention in care after 12 months of POC monitoring, with secondary outcomes including costs of POC monitoring, time to receipt of results, time to adherence counseling, and time to switch to second-line ART.…”

Section: Looking Ahead: the Role Of Poc Hiv Viral Load Testing Withinmentioning

confidence: 99%

“…Modeling population-level impact and cost-effectiveness plays an important role in translating clinical trial findings into a broader set of population estimates (47)(48)(188)(189)(190)(191). Through modeling, trial results can be translated into standardized impact metrics such as disability-adjusted life years (DALYs) averted or quality-adjusted life years (QALYs) gained, as well as indirect benefits such as reduced HIV transmission (48,136,137,192,193).…”

Section: Evidence From Modeling and Cost-effectiveness Role Of Modelimentioning

confidence: 99%

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Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response

et al. 2019

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SUMMARY The global public health community has set ambitious treatment targets to end the HIV/AIDS pandemic. With the notable absence of a cure, the goal of HIV treatment is to achieve sustained suppression of an HIV viral load, which allows for immunological recovery and reduces the risk of onward HIV transmission. Monitoring HIV viral load in people living with HIV is therefore central to maintaining effective individual antiretroviral therapy as well as monitoring progress toward achieving population targets for viral suppression. The capacity for laboratory-based HIV viral load testing has increased rapidly in low- and middle-income countries, but implementation of universal viral load monitoring is still hindered by several barriers and delays. New devices for point-of-care HIV viral load testing may be used near patients to improve HIV management by reducing the turnaround time for clinical test results. The implementation of near-patient testing using these new and emerging technologies may be an essential tool for ensuring a sustainable response that will ultimately enable an end to the HIV/AIDS pandemic. In this report, we review the current and emerging technology, the evidence for decentralized viral load monitoring by non-laboratory health care workers, and the additional considerations for expanding point-of-care HIV viral load testing.

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“… 48 Measures are being taken to strengthen EID programs and point of care virologic testing is gaining momentum, 10 , 49 – 51 and applications now extend to monitoring of pediatric and adult HIV treatment. 52 , 53 Over the past several years, new efforts have been made to find safe and potent ARVs with appropriate formulations and dosing for neonates and young infants 54 , 55 ( clinicaltrials.gov NCT01828073; NCT 02778204).…”

Section: Innovations Scientific Discovery and Collaboration: Diagnomentioning

confidence: 99%

Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration

Abrams

Ananworanich

Archary

et al. 2018

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background:A number of well-described obstacles to the pediatric therapeutic agenda have resulted in substantial delays in the introduction of new medications, formulations, strategies, and approaches to treat infants, children, and adolescents living with HIV.Setting:Global landscape.Methods:The authors will provide a summary of current and emerging initiatives to accelerate the pediatric therapeutic agenda including illustrative case studies of innovations and scientific discovery in diagnosis and treatment of very young children with HIV infection.Results:The challenges posed by rapid physiologic and developmental changes that characterize the trajectory of childhood as well as the complex regulatory and fiscal milieu of HIV therapeutics have hampered pediatric HIV therapeutic research. Recent efforts to accelerate this agenda include prioritizing agents and formulations, defining dosing by weight bands, applying innovative study designs, synergizing work across research networks to achieve common goals, and the establishment of a global prioritized research agenda. A case study of initiatives to diagnose and effectively treat newborns and infants will illustrate the critical role of basic science research and novel approaches to study design and implementation that are informing global efforts to end AIDS.Conclusions:A pediatric therapeutic agenda informed by basic science and achieved through innovation and global cooperation is essential to achieve an AIDS-free generation.

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Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study

Cited by 21 publications

References 43 publications

Comparative cost analysis of point-of-care versus laboratory-based testing to initiate and monitor HIV treatment in South Africa

Comparative cost analysis of point-of-care versus laboratory-based testing to initiate and monitor HIV treatment in South Africa

Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response

Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration

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