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Point-of-care Tests for Vaginal Discharge in Nepal
Sponsor: Norwegian University of Science and Technology
Summary
The goal of this clinical trial is to examine if and how the implementation of point-of care-tests (POCT) for sexually transmitted infections in the management of abnormal vaginal discharge reduces the overtreatment with antibiotics in a low income country. The setting is a university hospital in a semi-rural area in Nepal and several of its rural out-reach-centers. The plan is to include 1500 women attending the gynecological outpatients with a problem of vaginal discharge over approximately a one year period. The main questions the clinical trial aims to answer are: * Does POCT guided treatment result in reduced over-treatment of antibiotics, compared to the current approach in Nepal? * What are the barriers and facilitators of the acceptability of POCTs and the resulting treatment from the perspective of both patients and health care practitioners? Participants will be randomized in three groups: * standard treatment according to current practice * POCT result based treatment * POCT result based treatment plus patient education and addressing of psycho social vulnerabilities
Official title: Randomized Controlled Trial in Nepal: Introducing Point-of-care Tests and Identifying Barriers to Reduce Antibiotics for Vaginal Discharge
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2024-04-22
Completion Date
2026-01-25
Last Updated
2026-01-06
Healthy Volunteers
Yes
Interventions
Health care practitioner is informed of POCT results for CT and NG
Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative
Health care practitioner is informed about POCT result for TV and BV
The pH of vaginal secretion is measured from a self-collected swab by the research assistant, and if above 4.5 a dropp of KOH is added. If it smells fishy, the whiff test is positive.
addressing psycholsocial problems
1. Participants screening positive for anxiety, depression or domestic violence will be offered psychological counseling or referral to a crisis management center in the POCT-PLUS arm 2. All participants of the POCT-PLUS arm receive audio- visual and written education on vaginal discharge and antibiotics
Locations (1)
Dhulikhel Hospital
Dhulikhel, Kavre, Nepal