Performance of point-of-care birth HIV testing in primary health care clinics: An observational cohort study

Meggi, Bindiya; Vojnov, Lara; Mabunda, Nédio; Vubil, Adolfo; Zitha, Alcina; Tobaiwa, Ocean; Mudenyanga, Chishamiso; Mutsaka, Dadirayi; Bollinger, Timothy; Loquiha, Osvaldo; Peter, Trevor; Jani, Ilesh

doi:10.1371/journal.pone.0198344

Cited by 25 publications

(28 citation statements)

References 22 publications

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“…This indicates that with minimal extra training and support, clinical staff already employed within the hospital can successfully process POC samples using GeneX. The at birth POC error rate observed in our study (8.5%) was higher than at 6 weeks (2.6%), however comparable to that observed in other studies (4.8%-11%) [17,27,43]. Higher error rates at birth could be a result of difficulty collecting adequate sample from infants.…”

Section: Plos Onesupporting

confidence: 82%

“…Testing infants earlier (at birth) and with a more efficient point of care (POC) HIV diagnostic technology is emerging as a strategy to streamline EID, minimize challenges with traditional central laboratory-based PCR testing, and bridge the gap between EID demand and laboratory capacity. POC diagnostic technologies such as GeneXpert HIV-1 Qual [ 15 ] and Alere m-PIMA [ 16 ] are cartridge-based tests that can be processed at the hospital by trained clinical or laboratory staff and can result in more rapid turnaround times of results, more infants being identified as HIV-positive and more infants initiated on ART at younger ages than traditional testing strategies [ 17 – 22 ]. Studies have shown high sensitivity and specificity of POC testing and found that POC implementation is feasible in hospital-based settings in Kenya [ 23 , 24 ], South Africa [ 18 , 25 – 27 ], Mozambique [ 28 ], and Tanzania [ 29 ]; is acceptable to providers [ 26 ] and patients [ 30 ]; and may be a cost-effective option for EID [ 31 , 32 ].…”

Section: Introductionmentioning

confidence: 99%

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Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant

Wexler

Nazir

Maloba³

et al. 2020

PLoS ONE

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Background Testing infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya. Methods Four government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities). Results Of 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198

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Section: Plos Onesupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant

Wexler

Nazir

Maloba³

et al. 2020

PLoS ONE

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“…With funding from Unitaid, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) worked with the Ministry of Health of the Kingdom of Eswatini to pilot POC birth testing in three health facility maternity units, starting in 2016, building on an existing program of early infant testing using POC platforms. POC testing has been shown to reduce median turnaround time of results at 6 week testing from 55 to 0 days [13] and has also been shown to be feasible for testing at birth [14,15]. The opportunity to offer POC birth testing allows most caregivers to receive results before they are discharged from the hospital after delivery, or shortly thereafter, and thus can improve the survival chances of those found to be infected by starting treatment earlier.…”

Section: Introductionmentioning

confidence: 99%

“The right time is just after birth”: acceptability of point-of-care birth testing in Eswatini: qualitative results from infant caregivers, health care workers, and policymakers

et al. 2020

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Background: Testing for HIV at birth has the potential to identify infants infected in utero, and allows for the possibility of beginning treatment immediately after birth; point of care (POC) testing allows rapid return of results and faster initiation on treatment for positive infants. Eswatini piloted birth testing in three public maternities for over 2 years. Methods: In order to assess the acceptability of POC birth testing in the pilot sites in Eswatini, interviews were held with caregivers of HIV-exposed infants who were offered birth testing (N = 28), health care workers (N = 14), and policymakers (N = 10). Participants were purposively sampled. Interviews were held in English or SiSwati, and transcribed in English. Transcripts were coded by line, and content analysis and constant comparison were used to identify key themes for each respondent type. Results: Responses were categorized into: knowledge, experience, opinions, barriers and challenges, facilitators, and suggestions to improve POC birth testing. Preliminary findings reveal that point of care birth testing has been very well received but challenges were raised. Most caregivers appreciated testing the newborns at birth and getting results quickly, since it reduced anxiety of waiting for several weeks. However, having a favorable experience with testing was linked to having supportive and informed family members and receiving a negative result. Caregivers did not fully understand the need for blood draws as opposed to tests with saliva, and expressed the fears of seeing their newborns in pain. They were specifically grateful for supportive nursing staff who respected their confidentiality. Health care workers expressed strong support for the program but commented on the high demand for testing, increased workload, difficulty with errors in the testing machine itself, and struggles to implement the program without sufficient staffing, especially on evenings and weekends when phlebotomists were not available. Policymakers noted that there have been challenges within the program of losing mothers to follow up after they leave hospital, and recommended stronger linkages to community groups. Conclusions: There is strong support for scale-up of POC birth testing, but countries should consider ways to optimize staffing and manage demand.

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“…Two of the thirty and two additional studies with no comparative testing included reported on the clinical utility of POC results [14–17]. Of the two field reviews that reported on clinical utility [15, 17], one was a field feasibility evaluation study [14] and the other a cluster-randomized trial [16]. POC results were used for clinical management in two studies [14, 15].…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2019

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Background Point of-care (POC) HIV-1 RNA tests which are accurate and easy to use with limited infrastructure are needed in resource-limited settings (RLS). We systematically reviewed evidence of POC test performance compared to laboratory-based HIV-1 RNA assays and the potential utility of these tests for diagnosis and care in RLS. Methods Studies published up to July 2018 were identified by a search of PUBMED, EMBASE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials. Studies evaluating the use of POC HIV-1 RNA testing for early infant diagnosis (EID), acute HIV infection (AHI) diagnosis, or viral load monitoring (VL), compared to centralized testing, were included. Separate search strategies were used for each testing objective. Results 197 abstracts were screened and 34 full-text articles were assessed, of which 32 met inclusion criteria. Thirty studies evaluated performance and diagnostic accuracy of POC tests compared to standard reference tests. Two of the thirty and two additional studies with no comparative testing reported on clinical utility of POC results. Five different POC tests (Cepheid GeneXpert HIV-1 Quantitative and Qualitative assays, Alere q HIV‐1/2 Detect, SAMBA, Liat HIV Quant and Aptima HIV‐1 Quant) were used in 21 studies of VL, 11 of EID and 2 of AHI. POC tests were easy to use, had rapid turnaround times, and comparable accuracy and precision to reference technologies. Sensitivity and specificity were high for EID and AHI but lower for VL. For VL, lower sensitivity was reported for whole blood and dried blood spots compared to plasma samples. Reported error rates for Cepheid GeneXpert Qual (2.0%-5.0%), GeneXpert Quant (2.5%-17.0%) and Alere q HIV‐1/2 Detect (3.1%-11.0%) were higher than in WHO prequalification reports. Most errors resolved with retesting; however, inadequate sample volumes often precluded repeat testing. Only two studies used POC results for clinical management, one for EID and another for VL. POC EID resulted in shorter time-to-result, rapid ART initiation, and better retention in care compared to centralised testing. Conclusions Performance of POC HIV-1 RNA tests is comparable to reference assays, and have potential to improve patient outcomes. Additional studies on implementation in limited-resources settings are needed.

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Performance of point-of-care birth HIV testing in primary health care clinics: An observational cohort study

Cited by 25 publications

References 22 publications

Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant

Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant

“The right time is just after birth”: acceptability of point-of-care birth testing in Eswatini: qualitative results from infant caregivers, health care workers, and policymakers

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

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