Table 1 Tools, methods and description of information collected in the trial

Site assessment tool

• Completed by TTANGO Coordinators at baseline, and updated 6 monthly in all health services.

Broad description of:

(i) Clinical services and staffing

(ii) STI testing practices

(iii) Patient information system

(iv) Clinic setting as it relates to location of GeneXpert machine and consumables

Clinical data (quantitative)

• Collated from one or more of the following sources:

(i) Patient consultation data and associated demographics

(i) Health service patient information management systems

(ii) STI testing (point of care and laboratory), retesting and treatment outcomes

(ii) Laboratory data

• Extracted 3 monthly for all health services

Quality management data

• Services record results of EQA and forward to coordinators,

• External quality assurance and internal quality control test results

• twice during POC phase

• Temperature range of consumables during transport

• Internal quality control testing, once per month

• Multiple choice quiz and observed practice against competency standards

• Temperature monitoring of test consumables during transport

• Knowledge and competency assessment of staff following training in GeneXpert usage

Surveys (quantitative)

• Staff acceptability survey at end of POC phase

• Confidence using the test; satisfaction with training; trust in the results; ease of use; experience of discordant results; and impact on health service operations.

• Client acceptability survey, with attending clients in last month of POC phase

• Preference for testing modality (POC test vs conventional); convenience; satisfaction with test process and communication of results

In-depth interviews (qualitative)

• Stakeholders (national)

• Challenges and implications of introducing POC testing

• Stakeholders (national and international)

• Quality management and training considerations

• Health service staff

• Acceptability