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Point-of-care Tests for Vaginal Discharge in Nepal

Study acronym: POCT-BRA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints revised (3)
    • Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints revised (6)
    • Site details revised
    v7
  2. Primary completion date: Sep 25, 2025 to Dec 31, 2025v6
  3. Primary endpoints: 5 to 3v5 Show 4 more changesShow less
    • Primary completion date: Apr 21, 2025 to Sep 25, 2025
    • Study completion date: Aug 30, 2025 to Jan 25, 2026
    • Start date: Apr 21, 2024 to Apr 22, 2024
    • Secondary endpoints revised (6)
  4. Re-verified, no change to tracked fieldsv4
  5. Secondary endpoints: 4 to 6
    • Study description expanded, about 100 words
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 31, 2024 to Apr 21, 2025
    • Study completion date: Apr 30, 2025 to Aug 30, 2025
    • Start date changed from estimate of Feb 1, 2024 to Apr 21, 2024
    • Interventions: Health care practitioner is informed about POCT result for TV and BV (Diagnostic Test), Health care practitioner is informed of POCT… to Health care practitioner is informed about POCT result for TV and BV (Diagnostic Test), Health care practitioner is informed of POCT…
    • Study description expanded, about 5 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05977491
Lead Sponsor Norwegian University of Science and Technology
Collaborators: Kathmandu University School of Medical Sciences, University of Oslo, Universiteit Antwerpen
Conditions
(from sponsor)		 Vaginal Discharge, Sexually Transmitted Diseases
Related terms Anxiety Disorders, Depression, Sexually Transmitted Diseases, Vaginal Discharge, Vaginosis, Bacterial
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov