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

Wexler, Catherine; Nazir, Niaman; Maloba, May; Brown, Melinda; Goggin, Kathy; Gautney, Brad; Maosa, Nicodemus; Babu, Shadrack; Muchoki, Elizabeth; Mabachi, Natabhona; Lwembe, Raphael; Finocchario-Kessler, Sarah

doi:10.1371/journal.pone.0240621

Cited by 11 publications

(19 citation statements)

References 33 publications

(58 reference statements)

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“…Adaptions to implementation that occurred throughout the study period (modified logistics in terms of machine location, implementing personnel, workflow, and patient flow; improved mechanisms of interdepartmental communication; continuous OTJ training and site supervision) helped mitigate some of these challenges, but issues like power blackouts, machine breakdown, and high cost of cartridges will remain persistent barriers to sustainable implementation. These qualitative results support the quantitative evidence from our parent study [ 10 , 19 ] that suggests that POC testing can expedite infant diagnosis, but challenges in POC implementation can result in missed opportunities for testing [ 10 ] and delayed ART initiation [ 19 ]. Providers felt that engagement beyond the implementing team was insufficient and discussed how more active engagement from stakeholders in the inner and outer settings was needed to continue implementation post-study.…”

Section: Discussionsupporting

confidence: 79%

Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research

Wexler

Kamau

Muchoki

et al. 2021

Implement Sci Commun

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Background At-birth and point-of-care (POC) testing can expedite early infant diagnosis of HIV and improve infant outcomes. Guided by the Consolidated Framework for Implementation Research (CFIR), this study describes the implementation of an at-birth POC testing pilot from the perspective of implementing providers and identifies the factors that might support and hinder the scale up of these promising interventions. Methods We conducted 28 focus group discussions (FGDs) with 48 providers across 4 study sites throughout the course of a pilot study assessing the feasibility and impact of at-birth POC testing. FGDs were audio-recorded, transcribed, and analyzed for a priori themes related to CFIR constructs. This qualitative study was nested within a larger study to pilot and evaluate at-birth and POC HIV testing. Results Out of the 39 CFIR constructs, 30 were addressed in the FGDs. While all five domains were represented, major themes revolved around constructs related to intervention characteristics, inner setting, and outer setting. Regarding intervention characteristics, the advantages of at-birth POC (rapid turnaround time resulting in improved patient management and enhanced patient motivation) were significant enough to encourage provider uptake and enthusiasm. Challenges at the intervention level (machine breakdown, processing errors), inner settings (workload, limited leadership engagement, challenges with access to information), and outer setting (patient-level challenges, limited engagement with outer setting stakeholders) hindered implementation, frustrated providers, and resulted in missed opportunities for testing. Providers discussed how throughout the course of the study adaptations to implementation (improved channels of communication, modified implementation logistics) were made to overcome some of these challenges. To improve implementation, providers cited the need for enhanced training and for greater involvement among stakeholders outside of the implementing team (i.e., other clinicians, hospital administrators and implementing partners, county and national health officials). Despite provider enthusiasm for the intervention, providers felt that the lack of engagement from leadership within the hospital and in the outer setting would preclude sustained implementation outside of a research setting. Conclusion Despite demonstrated feasibility and enthusiasm among implementing providers, the lack of outer setting support makes sustained implementation of at-birth POC testing unlikely at this time. The findings highlight the multi-dimensional aspect of implementation and the need to consider facilitators and barriers within each of the five CFIR domains. Trial registration ClinicalTrials.gov, NCT03435887. Retrospectively registered on 19 February 2020

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Section: Discussionsupporting

confidence: 79%

Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research

Wexler

Kamau

Muchoki

et al. 2021

Implement Sci Commun

Self Cite

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“…In our parallel pilot study of PoC testing at these same sites, we experienced higher rates of missed testing opportunities due to machine/stock outs or invalid results (23.3%), 29 and delays in ART initiation still occurred largely due to the initial novelty of PoC in this setting. 29 , 30 Other larger PoC studies have reported more favorable findings, 19 , 31 and the benefit of PoC may be greater in settings with longer delays for laboratory-based PCR results. Furthermore, PCR HIV testing at birth and 6-week has been assessed as cost-effective, compared with EID at 6 weeks alone.…”

Section: Discussionmentioning

confidence: 97%

Piloting the Feasibility and Preliminary Impact of Adding Birth HIV Polymerase Chain Reaction Testing to the Early Infant Diagnosis Guidelines in Kenya

Finocchario-Kessler

Wexler

Brown

et al. 2021

Pediatric Infectious Disease Journal

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Background: In Kenya, standard early infant diagnosis (EID) with polymerase chain reaction (PCR) testing at 6-week postnatal achieves early treatment initiation (<12 weeks) in <20% of HIV+ infants. Kenya’s new early infant diagnosis guidelines tentatively proposed adding PCR testing at birth, pending results from pilot studies. Methods: We piloted birth testing at 4 Kenyan hospitals between November 2017 and November 2018. Eligible HIV-exposed infants were offered both point-of-care and PCR HIV testing at birth (window 0 to <4 weeks) and 6 weeks (window 4–12 weeks). We report the: proportion of infants tested at birth, 6-week, and both birth and 6-week testing; median infant age at results; seropositivity and antiretroviral therapy initiation. Results: Final sample included 624 mother-infant pairs. Mean maternal age was 30.4 years, 73.2% enrolled during antenatal care and 89.9% had hospital deliveries. Among the 590 mother–infants pairs enrolled before 4 weeks postnatal, 452 (76.6%) completed birth testing before 4 weeks, with 360 (79.6%) testing within 2 weeks, and 178 (39.4%) before hospital discharge (0–2 days). Mothers were notified of birth PCR results at a median infant age of 5.4 weeks. Among all 624 enrolled infants, 575 (92.1%) were tested during the 6-week window; 417 (66.8%) received testing at both birth and 6-weeks; and 207 received incomplete testing (93.3% only 1 PCR and 6.7% no PCR). Four infants were diagnosed with HIV, and 3 infants were initiated on antiretroviral therapy early, before 12 weeks of age. Conclusions: Uptake of PCR testing at birth was high and a majority of infants received repeat testing at 6 weeks of age.

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“…We estimated the following PCR monitoring-related costs in year 1: (1) GeneXpert ® instruments, (2) uninterrupted power supplies (UPS), (3) warranties, (4) calibration kits, (5) test cartridges, and (6) shipping for instruments and test cartridges. During years two to ve, the following PCR monitoringrelated costs were included: (1) calibration kits, (2) test cartridges, and (3) shipping costs for cartridges.…”

Section: Costsmentioning

confidence: 99%

“…The system is widely used in low-and middle-income countries (LMICs) for infectious diseases (e.g., TB, HIV) and utilization is increasing in a handful of oncology applications including BCR-ABL1 [5,6]. The Cepheid platform has many desired features in the LMIC setting, including ease and e ciency of use (less technical training needed, with exible use between batches or single assays), easy shipping solutions (cartridges rather than many different reagent supplies), high reproducibility, and reliable precision and accuracy.…”

Section: Introductionmentioning

confidence: 99%

Analysis of the Gap in PCR Monitoring Availability for Patients with Chronic Myeloid Leukemia in 60 Low- and Middle-Income Countries

Rowley

Garcia-Gonzalez

Radich

et al. 2021

Preprint

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Purpose: To estimate the resource gap in the polymerase chain reaction (PCR) monitoring for patients with chronic myeloid leukemia (CML) in low- and middle-income countries (LMICs). Methods: We developed a model of demand and supply of PCR monitoring of CML patients in 60 LMICs. PCR testing was assumed to use Cepheid’s GeneXpert® IV system. We included costs of GeneXpert® instruments, uninterrupted power supplies, warranties, calibration kits, test cartridges, and shipping. We calculated the country-specific monetary gap in PCR monitoring, stratified by country priority defined as the availability of tyrosine kinase inhibitors (TKIs) through The Max Foundation initiatives. Results: The five-year gap in PCR monitoring was $29.1 million across all countries, 22% ($6.4 million) in countries with all five TKIs available, 20% ($5.7 million) in countries with four TKIs available, 50% ($14.5 million) in countries with three TKIs available, 8% ($2.2 million) in countries with two TKIs available, and 1% ($0.3 million) in countries with one TKI available. The gap was highest in South Asia (52%; $15.1 million) and lowest in Latin America (6%; $1.9 million). Excluding labor costs, the bulk of the resource needs (86%; $25.2 million) were for procurement of BCR-ABL cartridges. Conclusion: Removing the five-year gap in PCR monitoring capacity for CML in LMICs will require the mobilization of significant resources and will likely lead to better treatment outcomes and reduced treatment costs through optimization of treatment, discontinuation of therapy in appropriate patients, and facilitation of clinical research. Development of streamlined monitoring guidelines for resource-limited countries should be considered.

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

Cited by 11 publications

References 33 publications

Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research

Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research

Piloting the Feasibility and Preliminary Impact of Adding Birth HIV Polymerase Chain Reaction Testing to the Early Infant Diagnosis Guidelines in Kenya

Analysis of the Gap in PCR Monitoring Availability for Patients with Chronic Myeloid Leukemia in 60 Low- and Middle-Income Countries

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