Point-of-care tests for vaginal discharge in Nepal
Randomized Controlled Trial in Nepal: Introducing Point-of-care Tests and Identifying Barriers to Reduce Antibiotics for Vaginal Discharge
NA · Norwegian University of Science and Technology · NCT05977491
This study tests if quick tests for sexually transmitted infections can help women in Nepal with abnormal vaginal discharge get better treatment and reduce unnecessary use of antibiotics.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Norwegian University of Science and Technology (other) |
| Locations | 1 site (Dhulikhel, Kavre) |
| Trial ID | NCT05977491 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of point-of-care tests (POCT) for sexually transmitted infections in managing abnormal vaginal discharge among women in Nepal. The study will include 1500 women attending gynecological outpatient clinics and will compare standard treatment with POCT-guided treatment to assess the reduction of antibiotic overtreatment. Additionally, the trial will explore the barriers and facilitators to the acceptability of POCTs from both patient and healthcare practitioner perspectives.
Who should consider this trial
Good fit: Ideal candidates for this study are women presenting with vaginal discharge at gynecological outpatient clinics.
Not a fit: Patients who are minors, have vaginal bleeding, or are suspected of having gynecological cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and reduced unnecessary antibiotic use for women with vaginal discharge.
How similar studies have performed: While there is limited research on the implementation of POCTs in low-income countries, similar approaches in high-income settings have shown success in reducing antibiotic overtreatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women presenting with vaginal discharge to gynecological outpatients Exclusion Criteria: * Minors below the age of 18 years. * Any bleeding from the vagina. * Suspicion of gynecological cancer. * Previous inclusion in the same study.
Where this trial is running
Dhulikhel, Kavre
- Dhulikhel Hospital — Dhulikhel, Kavre, Nepal (RECRUITING)
Study contacts
- Principal investigator: Risa AM Lonnee-Hoffmann, PhD — Norwegian University for Science and Technology
- Study coordinator: Risa AM Lonnee-Hoffmann, PhD
- Email: risa.lonnee-hoffmann@ntnu.no
- Phone: 004741482354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vaginal Discharge, Sexually Transmitted Diseases, antibiotic overtreatment, psychosomatic, domestic violence, anxiety and depression, chlamydia trachomatis, neisseria gonorrhoea