Table 2

Inclusion and exclusion criteria for both diagnostic and integration into care studies

Diagnostic studyIntegration into care study
Inclusion criteria
  • 18–35 years old

  • Willing and able to provide informed consent to participate in the study

  • Self-reported to be sexually active

  • Not pregnant (determined by pregnancy test)

  • Accessing family planning service

For all who are willing and able to provide informed consent to participate in the study.
  • User experiences/perceptions activity:

    • Local or regional policymakers, programmers and other opinion leaders and decision-makers

    • Healthcare professionals at health facilities—women who are eligible for the diagnostic study (including pregnant and menstruating women), but who are not part of the diagnostic study

  • Discrete choice experiments: women who are eligible for the diagnostic study (including pregnant and menstruating women), who are either part of, or not part of, the diagnostic study

  • Decision tree classification algorithm: data from diagnostic study participants

  • Economic evaluation: healthcare professionals at health facilities involved in GIFT device implementation able to complete timesheets

Exclusion criteria
  • <18 years or >35 years

  • Refusal by a participant to participate in the study

  • Treatment for any STI/BV in the past 30 days

  • Pregnancy

  • Enrolled in a study that does not allow co-enrolment in other studies

For all who are not willing or able to provide informed consent to participate in the study
  • User experiences/perceptions activity:

    • Non-relevant policymakers

    • Healthcare professionals at health facilities not included in diagnostic study

    • Women who are :

      • part of the diagnostic study

      • <18 years or >35 years

      • Treated for any STI/BV in the past 30 days

      • Pregnant

      • Enrolled in a study that does not allow co-enrolment in other studies

  • Decision tree classification algorithm: participants for whom there are no diagnostic study data

  • Economic evaluation: healthcare professionals not at study sites, not involved in GIFT device implementation and/or not able to complete timesheets

  • GIFT, Genital InFlammation Test.