Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care

Agutu, Clara; Ngetsa, Caroline; Price, Matt A.; Wit, Tobias F. Rinke de; Omosa-Manyonyi, Gloria; Sanders, Eduard J.; Graham, Susan M.

doi:10.1371/journal.pone.0218369

Cited by 40 publications

(33 citation statements)

References 52 publications

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“…In the studies included in this review, on‐site AEHI diagnosis was not possible in community‐based testing settings, but required laboratory‐based tests and skilled laboratory personnel. The emergence of point‐of‐care HIV‐RNA tests may enable on‐site community‐based AEHI testing in SSA [21]. However, no study approached AEHI testing in a comprehensive, culturally sensitive and integrated fashion in SSA.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, diagnosis of EHI requires a combination of HIV antibody, HIV‐RNA, and/or p24 assays [8,18‐20]. While AEHI testing, here defined as testing with a combination of HIV antibody, HIV‐RNA and p24 assays, was not available in most of SSA until recently, the emergence of point‐of‐care HIV‐RNA testing in SSA enables AEHI testing among a range of populations [21]. In some well‐resourced countries, national guidelines recommend AEHI testing for people who report risk behaviour and symptoms associated with AEHI [22,23], and facility‐based AEHI testing with HIV‐RNA can successfully identify AEHI among MSM [16,24‐29].…”

Section: Introductionmentioning

confidence: 99%

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Acute and early HIV infection screening among men who have sex with men, a systematic review and meta‐analysis

Palmer

Dijkstra

Ket

et al. 2020

J. Intern. AIDS Soc.

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Introduction: Screening for acute and early HIV infections (AEHI) among men who have sex with men (MSM) remains uncommon in sub-Saharan Africa (SSA). Yet, undiagnosed AEHI among MSM and subsequent failure to link to care are important drivers of the HIV epidemic. We conducted a systematic review and meta-analysis of AEHI yield among MSM mobilized for AEHI testing; and assessed which risk factors and/or symptoms could increase AEHI yield in MSM. Methods: We systematically searched four databases from their inception through May 2020 for studies reporting strategies of mobilizing MSM for testing and their AEHI yield, or risk and/or symptom scores targeting AEHI screening. AEHI yield was defined as the proportion of AEHI cases among the total number of visits. Study estimates for AEHI yield were pooled using random effects models. Predictive ability of risk and/or symptom scores was expressed as the area under the receiver operator curve (AUC). Results: Twenty-two studies were identified and included a variety of mobilization strategies (eight studies) and risk and/or symptom scores (fourteen studies). The overall pooled AEHI yield was 6.3% (95% CI, 2.1 to 12.4; I 2 = 94.9%; five studies); yield varied between studies using targeted strategies (11.1%; 95% CI, 5.9 to 17.6; I 2 = 83.8%; three studies) versus universal testing (1.6%; 95% CI, 0.8 to 2.4; two studies). The AUC of risk and/or symptom scores ranged from 0.69 to 0.89 in development study samples, and from 0.51 to 0.88 in validation study samples. AUC was the highest for scores including symptoms, such as diarrhoea, fever and fatigue. Key risk score variables were age, number of sexual partners, condomless receptive anal intercourse, sexual intercourse with a person living with HIV, a sexually transmitted infection, and illicit drug use. No studies were identified that assessed AEHI yield among MSM in SSA and risk and/or symptom scores developed among MSM in SSA lacked validation. Conclusions: Strategies mobilizing MSM for targeted AEHI testing resulted in substantially higher AEHI yields than universal AEHI testing. Targeted AEHI testing may be optimized using risk and/or symptom scores, especially if scores include symptoms. Studies assessing AEHI yield and validation of risk and/or symptom scores among MSM in SSA are urgently needed.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Acute and early HIV infection screening among men who have sex with men, a systematic review and meta‐analysis

Palmer

Dijkstra

Ket

et al. 2020

J. Intern. AIDS Soc.

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“…Many studies have found POC technologies to have high diagnostic accuracy [30,31] and be cost effective compared to conventional laboratory-based testing [16–20]. How these technologies perform in low throughput settings, what the strategies for scale-up of POC technologies are and whether they remain cost-effective relative to conventional centralized laboratory testing in terms of diagnostic accuracy or clinical impact, however, is not well understood [22,30]. By optimizing the allocation of POC technologies to reach the ‘last mile’ of viral load volumes, we have shown that costs can be reduced by as much as 35% for these viral loads compared to integrating these facilities into the centralized laboratory system, despite the cost of POC equipment and low patient volumes.…”

Section: Discussionmentioning

confidence: 99%

Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement

Girdwood

Nichols

Moyo³

et al. 2019

PLoS ONE

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Introduction Viral load (VL) monitoring programs have been scaled up rapidly, but are now facing the challenge of providing access to the most remote facilities (the “last mile”). For the hardest-to-reach facilities in Zambia, we compared the cost of placing point of care (POC) viral load instruments at or near facilities to the cost of an expanded sample transportation network (STN) to deliver samples to centralized laboratories. Methods We extended a previously described geospatial model for Zambia that first optimized a STN for centralized laboratories for 90% of estimated viral load volumes. Amongst the remaining 10% of volumes, facilities were identified as candidates for POC placement, and then instrument placement was optimized such that access and instrument utilization is maximized. We evaluated the full cost per test under three scenarios: 1) POC placement at all facilities identified for POC; 2)an optimized combination of both on-site POC placement and placement at facilities acting as POC hubs; and 3) integration into the centralized STN to allow use of centralized laboratories. Results For the hardest-to-reach facilities, optimal POC placement covered a quarter of HIV-treating facilities. Scenario 2 resulted in a cost per test of $39.58, 6% less than the cost per test of scenario 1, $41.81. This is due to increased POC instrument utilization in scenario 2 where facilities can act as POC hubs. Scenario 3 was the most costly at $53.40 per test, due to high transport costs under the centralized model ($36 per test compared to $12 per test in scenario 2). Conclusions POC VL testing may reduce the costs of expanding access to the hardest-to-reach populations, despite the cost of equipment and low patient volumes. An optimal combination of both on-site placement and the use of POC hubs can reduce the cost per test by 6–35% by reducing transport costs and increasing instrument utilization.

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“…Detection and management of AHI has been called a “clinical and public health emergency” [ 14 ] and a “common occurrence overlooked” [ 35 ]. POC HIV-1 RNA testing is becoming more available in sub-Saharan Africa and has multiple clinical uses, including viral load monitoring, early infant diagnosis, and AHI detection [ 36 ]. Because the cost of HIV-1 RNA testing is considerable, detection of AHI in resource-limited countries should be targeted using algorithms that identify at-risk individuals [ 37 ].…”

Section: Discussionmentioning

confidence: 99%

A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial

Graham¹,

Agutu²,

Elst³

et al. 2020

JMIR Res Protoc

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Background Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. Objective The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. Methods A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. Results Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. Conclusions The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. Trial Registration ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908 International Registered Report Identifier (IRRID) DERR1-10.2196/16198

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Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care

Cited by 40 publications

References 52 publications

Acute and early HIV infection screening among men who have sex with men, a systematic review and meta‐analysis

Acute and early HIV infection screening among men who have sex with men, a systematic review and meta‐analysis

Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement

A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial

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