Evaluation of a routine point-of-care intervention for early infant diagnosis of HIV: an observational study in eight African countries

Bianchi, Flavia; Cohn, Jennifer; Sacks, Emma; Bailey, Rebecca; Lemaire, Jean-François; Machekano, Rhoderick; Nzima, Valery; Ekouévi, Patricia Fassinou; Makone, Mafusi; Odhiambo, Collins; Chadambuka, Addmore; Masuku, Thembie; Sabonete, Manuel C; Fundi, Angelique R

doi:10.1016/s2352-3018(19)30033-5

Cited by 76 publications

(92 citation statements)

References 16 publications

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“…11 Finding patients LTFU is difficult and costly. 12 Point-of-care testing, as demonstrated in our analysis and in other studies, 7,9 clearly reduces LTFU of infants in need of confirmatory EID. This is achieved by enabling faster return of results to caregivers and immediate initiation on treatment.…”

Section: Ethical Approval and Informed Consentsupporting

confidence: 59%

Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya

Odhiambo

Githuka

Bowen³

et al. 2020

J Int Assoc Provid AIDS Care

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Introduction: We determine the level of adherence to the revised Kenya early infant diagnosis (EID) algorithm during implementation of a point-of-care (POC) EID project. Methods: Data before (August 2016 to July 2017) and after (August 2017 to July 2018) introduction of POC EID were collected retrospectively from the national EID database and registers for 33 health facilities. We assessed the number of HIV-infected infants who underwent confirmatory testing and received baseline viral load test and proportion of infants with an initial negative result who had a subsequent test. Results and Discussion: Significantly higher number of infants accessed confirmatory testing (94.2% versus 38.6%; P < .0001) with POC EID. Baseline viral load test and follow-up testing at 6 months, although higher with POC EID, were not significantly different from the pre-POC EID intervention period. Conclusion: The POC EID implementation has the potential to increase proportion of infants who receive confirmatory testing, thus reducing the risk of false-positive results.

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Section: Ethical Approval and Informed Consentsupporting

confidence: 59%

Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya

Odhiambo

Githuka

Bowen³

et al. 2020

J Int Assoc Provid AIDS Care

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“…The benefits include identification of suboptimal viral suppression and the opportunity to decrease transmission risk of HIV in the peri‐ and post‐partum period by prescribing high‐risk infant prophylaxis and addressing maternal viraemia respectively. HIV‐exposed infants benefit from improved result return, linkage to care and early ART initiation among HIV‐infected infants [11]. EID POC testing also provides an opportunity for immediate return of negative birth test results, reassuring mothers and counselling them on future HIV testing requirements for their infants.…”

Section: Discussionmentioning

confidence: 99%

“…POC VL testing improves turn‐around time (TATs) and retention in care among adults on ART [8], while POC EID testing reduces TATs and time to ART initiation in infants [9‐14]. Both have potential to reduce morbidity and mortality among pregnant WLHIV and their infants.…”

Section: Introductionmentioning

confidence: 99%

Point‐of‐care HIV maternal viral load and early infant diagnosis testing around time of delivery at tertiary obstetric units in South Africa: a prospective study of coverage, results return and turn‐around times

et al. 2020

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Introduction: Maternal viral load monitoring (mVL) and early infant diagnosis (EID) are necessary to achieve elimination of mother-to-child transmission of HIV. Point-of-care testing can achieve better outcomes compared to centralized laboratory testing (CLT). We describe the first implementation of point-of-care (POC) mVL and EID testing around delivery at four high volume tertiary obstetric units (TOUs) in Gauteng, South Africa. Methods: Prospective study of pregnant women living with HIV (WLHIV) and their infants. During the period 1 June 2018 to 31 March 2019, routine staff collected blood specimens from women and their infants around delivery. Specimen collection occurred throughout the week while dedicated POC operators, conducted testing during working hours on weekdays. Descriptive statistics and multivariable Poisson regression with robust error variance were used to describe outcomes and associated factors. Outcomes determined were (i) coverage of mVL and EID testing defined as a proportion of live births to WLHIV admitted at each facility (ii) results returned prior to discharge (iii) turn-around time (TAT) and iv) performance of POC testing compared to CLT. Results: In total, 8147 live births to pregnant WLHIV were recorded in the implementation period. Of these, 2912 mVL and 5074 EID specimens were included in the analysis, with 131 (4.5%) mVL and 715 (14.1%) EID specimens having initial invalid/ error results. Overall coverage of POC mVL and EID testing was 35.6% (range 20.9% to 60.1%) and 61.9% (range 47.0% to 88.0%) respectively. Proportions of POC tested mothers and infants with results returned prior to discharge were 74.3% (range 39.0% to 95.7%) and 73.0% (range 50.0 to 97.9%). Return of results was independently associated with TOU, afterhours specimen collection, having an initial invalid or error result and period of implementation. Overall TAT for specimens collected from mother-infant pairs where both had POC testing, during weekdays was longer for EID compared to mVL testing (median 3.3 hours vs. 2.9 hours, p-value sign test <0.001). POC results were comparable to those from laboratory testing. Conclusion: Accurate and timely POC mVL and EID testing around delivery was implemented with variable success across TOUs. Further scale up would need to address health system factors at facility level and high analytical error rates.

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“…As such, survival of HIV-infected infants highly depends on early HIV testing, prompt return of test results, and urgent initiation of ART [4]. Point-of-care (POC) early infant diagnosis (EID) of HIV allows for sample analysis at a peripheral health facility thereby improving access to testing and significantly reducing turnaround time (TAT) from sample collection to issuing of results to caregivers [5].…”

Section: Introductionmentioning

confidence: 99%

Task shifting for point-of-care early infant diagnosis: a comparison of the quality of testing between nurses and laboratory personnel in Zimbabwe

Simmonds¹,

Cohn²,

Mafaune³

et al. 2020

Hum Resour Health

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Background: To decentralize point-of-care early infant diagnosis (POC EID), task shifting to cadres such as nurses is important. However, this should not compromise quality of testing through generating high rates of internal quality control (IQC) failures and long result turnaround times. We used data from a POC EID project in Zimbabwe to compare IQC rates and result return to caregivers for samples run on a POC EID technology (Alere q HIV 1/2 Detect) between nurses and laboratory-trained personnel to assess effects of task shifting on quality of testing. Methods: This cross-sectional retrospective study used data from all 46 sites (10 hub and 36 spoke sites in Zimbabwe that piloted POC EID for routine clinical use from December 2016 to June 2017). IQC failure rates were downloaded from each POC EID platform and exported to excel to analyze IQC failure rates by type of operator. Turnaround time (TAT) from sample collection to issuing of results to caregiver was extracted from the EID test request form and uploaded into a project specific Excel-based database for analysis. Results: A total of 1847 tests were conducted by 45 testers (12 laboratory-trained and 33 non-laboratory-trained personnel), including 165 errors. There were no significant differences in IQC failure rates between non-laboratory testers (137 [9.2%] of 14830 tests) and specialized laboratory-trained (28 [7.7%] of 364 tests; p = 0.354). Over time, IQC failure rates for both non-laboratory (χ 2 = 18.5, p < 0.000) and specialized laboratory-trained testers (χ 2 = 8.7, p < 0.003) decreased significantly. There were similar proportions of clients who were issued with results between samples processed by non-laboratory testers (1283 [98.9%] of 1297 tests) and samples processed by specialized laboratory-trained testers (315 [98.7%] of 319 tests; p = 0.790). The overall median turnaround time from sample collection to receipt of results by caregiver for samples run by laboratory-specialized testers was not statistically different from samples run by non-laboratory-specialized testers (1 day [IQR 0-3] versus 0 days [IQR 0-2]; p = 0.583). Conclusions: Similar IQC failure rates and TATs between non-laboratory and specialized laboratory-trained operators suggest that non-specialized laboratory-trained personnel can perform POC EID equally well as specialized laboratory personnel.

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Evaluation of a routine point-of-care intervention for early infant diagnosis of HIV: an observational study in eight African countries

Cited by 76 publications

References 16 publications

Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya

Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya

Point‐of‐care HIV maternal viral load and early infant diagnosis testing around time of delivery at tertiary obstetric units in South Africa: a prospective study of coverage, results return and turn‐around times

Task shifting for point-of-care early infant diagnosis: a comparison of the quality of testing between nurses and laboratory personnel in Zimbabwe

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