Assessing stakeholder perceptions of the acceptability and feasibility of national scale-up for a dual HIV/syphilis rapid diagnostic test in Malawi

Abstract

Objectives The World Health Organization recommends pregnant women receive both HIV and syphilis testing at their first antenatal care visit, as untreated maternal infections can lead to severe, adverse pregnancy outcomes. One strategy for increasing testing for both HIV and syphilis is the use of point–of–care (rapid) diagnostic tests that are simple, proven-effective, and inexpensive. In Malawi, pregnant women routinely receive HIV testing, but only 10% are tested for syphilis at their first antenatal care visit. This evaluation explores stakeholder perceptions of a novel, dual HIV/syphilis rapid diagnostic test and potential barriers to national scale-up of the dual test in Malawi. Methods During June and July 2015, we conducted 15 semi-structured interviews with 25 healthcare workers, laboratorians, Ministry of Health leaders, and partner agency representatives working in prevention of mother-to-child transmission in Malawi. We asked stakeholders about the importance of a dual rapid diagnostic test, concerns using and procuring the dual test, and recommendations for national expansion. Results Stakeholders viewed the test favourably, citing the importance of a dual rapid test in preventing missed opportunities for syphilis diagnosis and treatment, improving infant outcomes, and increasing syphilis testing coverage. Primary technical concerns were about the additional procedural steps needed to perform the test, the possibility that testers may not adhere to required waiting times before interpreting results, and difficulty reading and interpreting test results. Stakeholders thought national scale-up would require demonstration of cost-savings, uniform coordination, revisions to testing guidelines and algorithms, training of testers, and a reliable supply chain. Conclusions Stakeholders largely support implementation of a dual HIV/syphilis rapid diagnostic test as a feasible alternative to current antenatal testing. Scale-up will require addressing perceived barriers; negotiating changes to existing algorithms and guidelines; and Ministry of Health approval and funding to support training of staff and procurement of supplies.

A Scoping Review of Supply Chain Management Systems for Point of Care Diagnostic Services: Optimising COVID-19 Testing Capacity in Resource-Limited Settings

“…The eligible studies were published between 2011 and 2021. The 31 articles included 15 reviews [ 10 , 12 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 ], 1 website of an international organisation [ 33 ], 2 randomised controlled trials [ 34 , 35 ], 1 cross-sectional study [ 36 ], 1 case study [ 37 ], 1 cohort study [ 38 ] and 10 studies that used mixed method approaches ranging from focus group discussions to interviews to direct observations [ 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ]. The included articles presented evidence of research conducted in the following countries: Mozambique [ 34 , 36 , 44 ], Zimbabwe [ 49 ], Ghana [ 12 , 21 , 22 , 40 , 45 , 48 ], Malawi [ 42 ], Namibia [ 41 ], India [ 43 ], Sierra Leone [ 37 ], Burkina Faso [ 38 ], The Philippines [ ...…”

“…Evidence on the following POC diagnostic tests were provided: COVID-19 [ 27 , 28 , 33 ]; HIV [ 10 , 12 , 22 , 23 , 24 , 25 , 26 , 34 , 36 , 42 , 49 ]; malaria [ 10 , 12 , 22 , 23 , 34 , 35 , 38 , 40 , 41 , 43 , 44 , 46 , 47 , 48 ]; syphilis [ 10 , 12 , 23 , 32 , 34 , 39 , 42 , 45 ]; tuberculosis [ 30 , 31 ] and others comprising of anaemia [ 34 , 40 ], UTI [ 37 ], diabetes [ 12 , 31 ], blood glucose [ 22 ], preeclampsia urinalysis [ 37 ], urine pregnancy [ 22 ], urine protein [ 22 , 34 ], haemoglobin [ 22 ], dyslipidaemia […”

“…The eligible studies provided evidence on at least one aspect of the SCM system. The aspects of the SCM systems covered were procurement and stockouts [ 10 , 12 , 21 , 24 , 25 , 26 , 33 , 34 , 36 , 41 , 42 , 43 , 44 , 45 , 47 , 49 ], quality assurance [ 10 , 23 , 24 , 27 , 29 , 31 , 32 , 37 , 46 , 48 , 49 ], safe disposal [ 46 ], inventory management [ 10 , 12 , 21 , 25 , 35 , 36 ], selection [ 10 , 22 , 28 , 33 , 46 ], distribution [ 12 , 21 , 22 , 34 , 38 , 41 , 48 ], quantification [ 12 ], storage [ 12 , 21 , …”

“…The 15 studies that were appraised for methodological quality scored between 90% and 100%, which showed high methodological quality. Twelve studies scored the highest quality score of 100% [ 34 , 35 , 36 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 47 , 48 ]. One study scored 95% [ 38 ].…”

“…In most of the studies, POC diagnostic services relied solely on government supplies [ 35 , 37 , 39 , 41 , 42 , 43 , 45 ]. Two articles reported that the supply of POC diagnostic tests was insufficient and sporadic [ 12 , 48 ].…”