Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers’ Perspectives on Testing, Training and Quality Assurance

Abstract

Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues.

REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes

“…The main reasons for this are the lack of advocacy and political will to translate the evidence to national policy, lack of funding to make the tests affordable to those in need and the lack of a national control programmes to provide the architecture needed to coordinate all the different aspects of testing. Ensuring adequate training for health care workers and supplies of commodities were cited as key implementation barriers in Africa 30,31 .…”

“…Countries need to harness the architecture provided by HIV PMTCT programmes to screen women for both infections using a single drop of blood in a single visit to a health care facility. Dual rapid HIV-syphilis RDTs with acceptable performance are now available 36 and the WHO, as well as many countries, has adopted these HIV and/or syphilis RDTs into their national guidelines 31,37 .…”

A study on usefulness of a set of known risk factors in predicting maternal syphilis infections in three districts of Western Province, Zambia

“…An estimated 11 million people are infected with syphilis globally every year; of these 1.5 million are pregnant women [ 1 ]. Maternal syphilis can lead to adverse pregnancy outcomes (APO) in 53.4 - 81.8% cases [ 2 ] such as spontaneous abortions, intra-uterine growth retardation, still births, premature deliveries, low-birth weight, perinatal deaths and congenital disease among new-born babies [ 3 , 4 ]. To contribute towards control of maternal syphilis and its APOs, the World Health Organization (WHO) recommends antenatal screening of all pregnant women [ 5 ].…”

The role of Point-of-Care testing in the diagnosis of syphilis

“…Studies on the impact of POC tests in screening pregnant women [49,50] have reported that there was a substantial increase in antenatal syphilis screening following introduction of these types of tests. This was true for different settings: from urban to rural, primary health care centres or hospitals, and in countries with different health systems and cultural and socioeconomic contexts in Africa, Asia, and South America.…”

“…Health professionals and some authors also felt that training, supervision, and quality assurance must be strengthened and made an integrated part of POCT programmes [24,50,60,61]. Moreover, some health care workers stated that training would overcome their fear of communicating positive results and improve partners' notification [42].…”