Facilitators and barriers for clinical implementation of a 30-minute point-of-care test for Neisseria gonorrhoeae and Chlamydia trachomatis into clinical care: A qualitative study within sexual health services in England

Point-of-care tests (POCTs) to diagnose sexually transmitted infections (STIs) have potential to positively impact patient management and patient perceptions of clinical services. Yet there remains a disconnect between development of new technologies and their implementation into clinical care. With the advent of new STI POCTs arriving to the global market, guidance for their successful adoption and implementation into clinical services is urgently needed. We conducted qualitative in-depth interviews with professionals prior to and post-implementation of a Chlamydia trachomatis/Neisseria gonorrhoeae POCT into clinical services in England to define key stakeholder roles and explore the process of POCT integration. Participants self-identified themselves as key stakeholders in the STI POCT adoption and/or implementation processes. Data consisted of interview transcripts, which were analysed thematically using NVIVO 11. Six sexual health services were included in the study; three of which have implemented POCTs. We conducted 40 total interviews: 31 prior to POCT implementation and 9 follow-up post-implementation. Post-implementation data showed that implementation plans required little or no change during service evaluation. Lead clinicians and managers self-identified as key stakeholders for the decision to purchase, while nurses self-identified as “change champions” for implementation. Many identified senior clinical staff as those most likely to introduce and drive change. However, participants stressed the importance of engaging all clinical staff in implementation. While the accuracy of the POCT, its positive impact on patient management and the ease of its integration within existing pathways were considered essential, costs of purchasing and utilising the technology were identified as central to the decision to purchase. Our study shows that key decision-makers for adoption and implementation require STI POCTs to have laboratory-comparable accuracy and be affordable for purchase and ongoing use. Further, successful integration of POCTs into sexual health services relies on supportive interpersonal relationships between all levels of staff.


Introduction
Problem formulation -Description and significance of the problem/phenomenon studied; review of relevant theory and empirical work; problem statement Page 3-4 Purpose or research question -Purpose of the study and specific objectives or questions Pages 4

Methods
Qualitative approach and research paradigm -Qualitative approach (e.g., ethnography, grounded theory, case study, phenomenology, narrative research) and guiding theory if appropriate; identifying the research paradigm (e.g., postpositivist, constructivist/ interpretivist) is also recommended; rationale** Page 5 Researcher characteristics and reflexivity -Researchers' characteristics that may influence the research, including personal attributes, qualifications/experience, relationship with participants, assumptions, and/or presuppositions; potential or actual interaction between researchers' characteristics and the research questions, approach, methods, results, and/or transferability Page 6-7 Context -Setting/site and salient contextual factors; rationale** Page 6 Sampling strategy -How and why research participants, documents, or events were selected; criteria for deciding when no further sampling was necessary (e.g., sampling saturation); rationale** Page 6 Ethical issues pertaining to human subjects -Documentation of approval by an appropriate ethics review board and participant consent, or explanation for lack thereof; other confidentiality and data security issues Page 7 Data collection methods -Types of data collected; details of data collection procedures including (as appropriate) start and stop dates of data collection and analysis, iterative process, triangulation of sources/methods, and modification of procedures in response to evolving study findings; rationale** Pages 6-7 Data collection instruments and technologies -Description of instruments (e.g., interview guides, questionnaires) and devices (e.g., audio recorders) used for data collection; if/how the instrument(s) changed over the course of the study Page 6 Units of study -Number and relevant characteristics of participants, documents, or events included in the study; level of participation (could be reported in results) Page 6 Data processing -Methods for processing data prior to and during analysis, including transcription, data entry, data management and security, verification of data integrity, data coding, and anonymization/de-identification of excerpts Page 7 Data analysis -Process by which inferences, themes, etc., were identified and developed, including the researchers involved in data analysis; usually references a specific paradigm or approach; rationale** Page 7 Techniques to enhance trustworthiness -Techniques to enhance trustworthiness and credibility of data analysis (e.g., member checking, audit trail, triangulation); rationale** Page 7

Results/findings
Synthesis and interpretation -Main findings (e.g., interpretations, inferences, and themes); might include development of a theory or model, or integration with prior research or theory Page 8-9 Links to empirical data -Evidence (e.g., quotes, field notes, text excerpts, photographs) to substantiate analytic findings Pages 9-14

Discussion
Integration with prior work, implications, transferability, and contribution(s) to the field -Short summary of main findings; explanation of how findings and conclusions connect to, support, elaborate on, or challenge conclusions of earlier scholarship; discussion of scope of application/generalizability; identification of unique contribution(s) to scholarship in a discipline or field Pages 14-15 Limitations -Trustworthiness and limitations of findings Page 16-17

Other
Conflicts of interest -Potential sources of influence or perceived influence on study conduct and conclusions; how these were managed Page 18-19 Funding -Sources of funding and other support; role of funders in data collection, interpretation, and reporting Page 19 *The authors created the SRQR by searching the literature to identify guidelines, reporting standards, and critical appraisal criteria for qualitative research; reviewing the reference lists of retrieved sources; and contacting experts to gain feedback. The SRQR aims to improve the transparency of all aspects of qualitative research by providing clear standards for reporting qualitative research. **The rationale should briefly discuss the justification for choosing that theory, approach, method, or technique rather than other options available, the assumptions and limitations implicit in those choices, and how those choices influence study conclusions and transferability. As appropriate, the rationale for several items might be discussed together.