Background
Low-and-middle-income countries share the highest burden of sexually transmitted infections (STIs), with
Neisseria gonorrhoeae (
N. gonorrhoeae) estimated to be higher in the African region as compared to other regions [
1,
2]. Untreated STIs can lead to pelvic inflammatory disease, infertility, and other adverse pregnancy and birth outcomes; also, these may facilitate HIV transmission and acquisition [
3‐
5]. Provider-initiated symptom screening and syndromic management of STIs is currently the standard of care and is widely implemented in resource-constrained settings per WHO guidelines [
6‐
8]. South Africa, and most other resource-constrained countries, has integrated syndromic STI screening for patients at primary care to improve accessibility and efficiency. Although relatively cheap and easy to implement, the syndromic STI approach is associated with unnecessary use of antibiotics, impacting on antimicrobial resistance (AMR), and resulting in asymptomatic infections being untreated [
9,
10].
Etiological testing and treatment of infections such as STIs is often challenging in resource-constrained settings due to costs, poor access to laboratory testing, and long turnaround times [
3,
11]. Molecular diagnostic tests (e.g. Polymerase chain reaction) are available, but these are often expensive, require a skilled technical workforce and have longer processing and turnaround times [
12]. To date, point-of-care STI testing for many low-and-middle-income countries primary care settings is often limited to HIV and syphilis antibody rapid tests. A rapid, affordable, and easy-to-use
N. gonorrhoeae point-of-care test (POCT) with high sensitivity and specificity could increase access to etiological diagnosis, improve STI treatment appropriateness and outcome, and reduce risks for ongoing transmission and lost-to-follow-up [
11‐
14]. In response to the need for
N. gonorrhoeae POCT, FIND together with the World Health Organization (WHO) developed a
N. gonorrhoeae POCT target product profile [
15]. Subsequently, a rapid lateral flow assay with fluorescence-based detection (NG-LFA) with a prototype reader was developed by FIND for
N. gonorrhoeae detection [
16,
17]. The NG-LFA showed excellent performance (sensitivity > 90%, specificity > 95%), and test accuracy amongst symptomatic male and female patients visiting South African primary healthcare facilities [
18]. Thus far, the NG-LFA has shown high learnability, usability and acceptability amongst trained healthcare professionals and fieldworkers integrated within public healthcare facilities [
19,
20].
Importantly, the availability of accurate and sensitive STI POCTs does not guarantee adoption by end-users in routine care. Despite good diagnostic performance, implementation challenges were previously reported amongst antenatal syphilis screening, malaria POCTs, new TB treatment programs and HIV testing and counselling interventions [
20‐
24]. Although STI testing and specimen collection may be feasible and acceptable amongst primary care patients, the required resources and facility infrastructure for test execution, result interpretation, patient flow, and perceived impact pose important considerations for integration and adoption [
25‐
28]. Barriers for implementation may further include issues with leadership, user willingness, consideration for workloads, and privacy challenges [
13,
20‐
22,
29‐
33]. Exploring healthcare provider perceptions, implementation processes and social and organizational factors will reveal provider beliefs and practices that inform best strategies to ‘normalize’ rapid
N. gonorrhoeae POCT amongst patients [
16,
28,
29,
33,
34].
The following qualitative study unpacks the end-user’s experience of the NG-LFA within primary healthcare facilities and provides critical assessments to inform integration and perceived impact for STI management in South African healthcare settings. Furthermore, specific context and end-user values may inform developers of appropriateness and adaptability as POCTs become more readily available [
31,
35].
Discussion
This qualitative study is the first to describe the implementation experiences of a novel
N. gonorrhoeae rapid POCT within the South African healthcare environment. Implementation and end-user receptivity amongst trained healthcare workers was evaluated through varying organizational levels using the specific features of this NG-LFA and the general features of the target product profile [
15]. Rather than proposing structural change, the findings show adaptive execution within the current clinic environment and health programs.
Figure
4 and Additional Table
2 describes how the facility environment and implementation experiences inform the NPT constructs and the proposed process of moving from syndromic to targeted treatment and care for STIs in primary healthcare. Implementing healthcare workers described the
strategic intentions for the NG-LFA during pre-implementation and initial use by reiterating the need for STI POCT given limitations with syndromic management [
11]. This was further shared by examples from government clinic-staff of patients who referred patients with recurring symptoms, whereby the NG-LFA could offer (immediate) resolution [
13]. Study healthcare workers relied on the existing patient flow and worked alongside government clinic staff to successfully implement the NG-LFA within the existing health structure. This demonstrates preliminary
negotiating capacities or buy-in, as well as the
collective execution and participation of the
N. gonorrhoeae test. The study healthcare professionals led the diagnostic test evaluation with the assistance of the fieldworkers that optimized the use of the test [
42]. Further investigations for evaluating the performance of the NG-LFA and patient preferences may be required to assess the possibility for asymptomatic testing services and self-collected specimens given space constraints, and for task-shifting opportunities from professional nurses to paraprofessionals. However, these must not compromise end-user and patient trust of the device [
35].
This study raises the importance of assessing organizational readiness, designated responsibilities, and service flow that ensures STI screening and preventative care is given adequate attention [
20]. Given the lack of STI targeted testing and screening at primary healthcare, we begin to address this by showing how the NG-LFA best fits within the current context. Aligning the NG-LFA test with existing and relevant patient services such as HIV counselling and testing, checking for vitals, and family planning could for instance help streamline STI screening specimen collection and long patient waiting times. Paraprofessionals involved in these services could test for STIs as similarly performed for HIV where self-collected specimens would remove the dependence on professional nurses to execute testing. Healthcare services such as physical examinations during antenatal care of family planning (e.g., pap smears), would also provide a conducive opportunity for vaginal specimen collection. Further, the NG-LFA was perceived as suitable given resource limitations and the ability to refer patients for other services whilst POCTs are executed [
30].
However, when considering the
adaptive execution of the NG-LFA (and how the environment informs this adaptation), some healthcare workers discussed the impact of adding another testing service on a burdened healthcare system sustained by professional nurses. In South Africa, integrated care ensures that patients largely receive efficient and holistic care from the same provider. However, some concerns were raised for increased workloads [
43]. Some health care professionals felt the NG-LFA would be more appropriate for dedicated departments (vertical implementation) due to convenience and perceived need (e.g., youth and adolescent services, family planning etc.) [
44]. Others mentioned it was important to offer comprehensive care or clinical oversight for a patient for STI care and thus felt STI screening should be part of integrated care. This shows that the existing context may influence how each clinic may establish different workarounds for how the NG-LFA could best be integrated [
28].
Implementing healthcare workers were able to draw comparisons between Xpert and other rapid tests (e.g., for HIV), particularly highlighting some differences for current specimen collection procedures, quick results, and the easy interpretation of the results for the NG-LFA. These differences and perceived benefits for the NG-LFA depicted healthcare workers’
coherence and internalization of POCT for
N. gonorrhoeae. As shown in previous POCT studies, awareness and observability of the NG-LFA testing procedures appeared to promote patient and provider satisfaction and trust in the device [
32,
36,
45]. As intended with proposed target product profile, the NG-LFA was also perceived to guide better clinical management. Similarly to experiences amongst other healthcare workers using POCTs in Uganda, staff appreciated the clarity for treatment provided by the NG-LFA and described more confidence and efficacy in their clinical decision-making [
13,
46].
During the
reflexive monitoring process, both healthcare professionals and field workers shared the perception that an easily accessible STI POCT at the primary healthcare level could allay testing apprehension [
32], also caused by long waiting times for test results [
30]. Feedback indicates that testing receptivity is increased with STI testing that is clearly described, quick, inconspicuous, accurate, and which enables fast diagnosis for those presenting with symptoms – in addition to reducing stigma and improving same-day treatment [
13,
42,
47,
48]. Further, healthcare workers described how diagnostic testing for
N. gonorrhoeae would create STI awareness amongst providers and patients as previously found with molecular tests [
13], and highlights the importance of conducting physical examinations during primary care. The implementation of STI POCTs however begs consideration for additional resources for targeted treatment protocols and partner referral procedures, such as designated private spaces for STI treatment, partner notification, and testing.
Strengths and limitations
This qualitative study included a large sample of interviews conducted at different timepoints that offered in-depth implementation experiences using the NG-LFA over a six-month timeframe. Findings from this study reveal key social and organizational interactions at primary health-care levels with implications for current STI testing and treatment guidelines. The implementation context is unique to the South African primary health care system but may provide insights for similar low- and middle-income health systems.
The current study design does not allow for the assessment of the intervention performance, restructuring and sustainment of the NG-LFA within primary healthcare. Not addressed here are important post-implementation issues relating to stock-outs and quality assurance for testing in context of routine service delivery, as these were directly controlled by study staff. While this study marks the initial step to delineate end-user encounters of a novel rapid POCT in a primary healthcare setting, it is important to explore the preferences and experiences of patients as well as key informants during device development. These could further enhance our understanding of patient and provider acceptance, partner testing, and clinical management. Additionally, organizational readiness and the cost-effectiveness of targeted STI treatment within primary care warrants further investigation [
21,
22,
35].
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