Randomised controlled trial in Nepal: Implementing point-of-care tests and identifying barriers to reduce antibiotics for vaginal discharge

Randomised controlled trial in Nepal: Implementing point-of-care tests and identifying barriers to reduce antibiotics for vaginal discharge

Vaginal discharge (VD) is a common symptom of sexually transmitted infections (STIs) and other infections. In lowincome countries (LICs) there is a lack of laboratory facilities for specific diagnosis and therefore women receive several types of antibiotics, causing over treatment, which is contributing to antimicrobial resistance. The World Health Organisation recommends research on the use of point of care tests (POCTs) in LICs.

This study implements and evaluates a combination of two POCTs; the first is a sophisticated test for the two most serious STIs causing VD, where excellent diagnostic properties have been demonstrated in high-income settings, while the other is a simpler test. Diagnostic accuracy studies for these tests in a LIC setting are lacking. Up to half of the women with VD will not have any infection and there are indications, that psychosocial problems may be expressed as somatic symptoms, specifically VD, in certain cultures. Further, in many LIC, over-the-counter sale of antibiotics without prescription is widespread and treatment recommendations without antibiotics following a negative POCT may not be followed by patients. We therefore hypothesise that for a successful implementation of POCTs in this context, patients' psychosocial vulnerabilities and knowledge gaps need to be addressed.

We have designed a randomised controlled trial(RCT)with three arms:comparing 1)treatment as usual with 2)POCT based treatment and with 3)POCT based treatment plus addressing knowledge gaps (with an education tool developed prior to the RCT) and psychosocial vulnerabilities (patients screening positive for anxiety, depression or domestic violence will be addressed by the attending health practitioner). Patients are followed up with a telephonic interview after 1 and 4 months. Our multidisciplinary research group has expertise in gynaecology, microbiology, psychiatry, epidemiology and social science and will apply quantitative and qualitative methods.