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GLOBVAC-Global helse- og vaksin.forskn

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

Alternative title: Redusert antibiotika bruk ved vaginal utflod - en randomisert kontrollert studie i Nepal

Awarded: NOK 6.9 mill.

Abnormal vaginal discharge is a common symptom of vaginal or sexually transmitted infections (STIs). In low-income countries, diagnostic laboratory tests are not readily accessible and women may receive several types of antibiotics for abnormal vaginal discharge to cover a range of potential STIs, contributing to the development of antibiotic resistance. Recently accurate point-of-care tests (POCTs) have been developed, but their performance in low-income country contexts is not established. Up to half of women complaining of vaginal discharge do not have an infection; previous research suggests the complaint may be related to psychosocial problems. In addition, over-the-counter sale of antibiotics is widespread in low-income countries. Education about vaginal discharge and its treatment may be required to ensure adherence to treatment recommendations, also when no antibiotics are recommended. In this collaboration between the Norwegian University of Science and Technology and universities in Kathmandu (Nepal), Oslo (Norway) and Antwerp (Belgium), with advisory input from the World Health Organization (WHO), we will include 1500 women with the complaint of abnormal vaginal discharge in a randomized controlled trial (RCT) at semirural and rural outpatient clinics in Nepal. In the RCT, we will compare the amount of antibiotics used in three study groups:1) treatment as usual, 2) treatment according to POCTs and 3) treatment according to POCTs plus information on vaginal discharge. We will evaluate three POCTs: a simple test for trichomonas infection and two advanced tests for chlamydia infection and gonorrhea. One of these is a new POCT with results available after 30 minutes. We will validate this test with the other test, which has been shown to be highly accurate. Furthermore, we will examine patient and health practitioner experience with the POCTs. Women will also be screened for psychosocial problems, with relevant follow-up and referral for positive cases.

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)PPOCT 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.

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GLOBVAC-Global helse- og vaksin.forskn