Point-of-care Tests for Vaginal Discharge in Nepal

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

Conditions

• Vaginal Discharge
• Sexually Transmitted Diseases

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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.

OTHER

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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Risa AM Lonnee-Hoffmann, PhD · Norwegian University for Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-22

Primary Completion

2025-12-31

Completion

2026-01-25

Countries

• Nepal

Study Locations