Point-of-care Tests for Vaginal Discharge in Nepal

NCT05977491 | Active Not Recruiting

• 1 other identifier: 335889
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

antibiotic overtreatment; psychosomatic; domestic violence; anxiety and depression; chlamydia trachomatis; neisseria gonorrhoea; trichomonas vaginalis; bacterial vaginosis; process evaluation; point-of-care-test

Outcome Measures

Primary Outcomes (3)

• Proportion of participants overtreated with antibiotics (excluding antifungals)

  Comparing the proportion of women overtreated with antibiotics for treatment depending if the health care practitioner was informed about the POCT results (arm 2+3) or not (arm1). Reported by the health care practitioner. Overtreatment is defined as receiving a cephalosporin when NG is negative; a tetracycline when CT is negative; a macrolide when NT and CT are neagtive; a nitroimidazole when the gold standard test for TV or BV is negative. These subgroups are anlayzed: (a) before addition of an additional POCT for women with a pH above 4.5 and a negative whiff test, this is the first half of participants; (b) after addition of this extra test, for the second half of included participants; (c) suburban- and (d) rural clinics. We compare arm 1 with the combined arms 2+3.

  At inclusion

• Proportion of participant prescribed antimicrobial resistance driving antibiotics

  Comparing the proportion of women in arm 1( comparison arm) compared to arm 2 and 3 (intervention arms), receiving AMR driving antibiotics (Cephalosporins, Azithromycin, Ciprofloxacillin), depending if the health practitioner received POCT results. These subgroup analysis are planned: (a) suburban vs urban clinics. We compare arm 1 with the combined arms 2+3.

  At inclusion.

• Proportion of participants adhering to treatment recommendations

  Among participants, where the health practitioner had received POCT results, we compare the proportion of women adhering to treatment recommendations, depending on if they received psycho social intervention (arm 3) or not (arm2), in the arm Adherence is defined as follows: (1) participants report they took the prescribed medication, (2) no additional purchase of antibiotics; (3) no purchase of other medication for VD. Subgroup analysis for (a) suburban and (b) rural areas. (c) participants screening positive for domestic violence or (d) anxiety or depression, offered counseling or not. We compare all arms (arm1, 2 and 3)

  At telephonic follow up after 1 month.

Secondary Outcomes (6)

• Proportion of participants prescribed antibiotics

  At inclusion

• Undertreatment with antibiotics for CT, NG, TV and BV with or without POCT guided treatment

  At inclusion

• Proportion of women adhering to treatment recommendationss

  At telephonic follow up 4 months after initial consultation

• Does educational and psychosocial measures affect change in VD symptoms?

  At telephonic follow up after 4 weeks and 4 months.

• Comparing prevalence of screening positive for anxiety and depression before and 4 months after consultation for VD

  At telephonic follow up, 4 months after initial consultation

Other Outcomes (4)

• Prevalence STIs and associated demographic and clinical findings

  at enrollment

• Associations between self reported domestic violence, anxiety and depression and STI diagnosis

  at enrollment

• Diagnostic accuracy for bacterial vaginosis(BV) and/or Trichomonas Vaginalis (TV) with pH and whiff test

  First 500 participants at Dhulikhel Hospital and first 250 participants at ORC.

Study Arms (3)

Standard treatment

NO INTERVENTION

Patients are treated by the health care practitioner according to local protocol. This protocol corresponds to the syndromic approach without laboratory or microscopic testing. This may or may not include inspection and examination of the vulva, vagina, cervix and lower abdomen.

POCT based treatment

ACTIVE COMPARATOR

The health care practitioner is informed about the POCT results for CT and NG (positive or negative). In addition, if the pH is within the normal level (4.5 and below). If it is higher, he will receive the outcome of the whiff test (positive or negative). For the second half of enrolled participants: if pH is \> 4.5 and whiff test is negative, the OSOM test for TV will be performed an self collected vaginal discharge. The Health care practitioner is informed if the TV test is positive or negative. Examination of the patient is performed according to the discretion of the health care practitioner.

Diagnostic Test: Health care practitioner is informed of POCT results for CT and NG; Diagnostic Test: Health care practitioner is informed about POCT result for TV and BV

POCT based treatment PLUS

ACTIVE COMPARATOR

Same as in POCT based treatment PLUS in addition: 1. All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, they are offered psychological counseling. All women are informed about referral possibilities to a crisis management center. 2. Patients are given a short educational leaflet and 10 min audio-recording about physiological and abnormal vaginal discharge and about problems associated with unnecessary use of antibiotics.

Diagnostic Test: Health care practitioner is informed of POCT results for CT and NG; Diagnostic Test: Health care practitioner is informed about POCT result for TV and BV; Other: addressing psycholsocial problems

Interventions

Health care practitioner is informed of POCT results for CT and NG DIAGNOSTIC_TEST

Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative

Also known as: GeneXpert test from Cepheid for CT andNG

POCT based treatment; POCT based treatment PLUS

Health care practitioner is informed about POCT result for TV and BV DIAGNOSTIC_TEST

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.

Also known as: Narrow range pH and confirmatory whiff test with potassium hydroxide (KHO), Amsel criteria, for second half of participants to be included: if pH > 4.5 and whiff test is negative, the OSOM test will be performed for TV

POCT based treatment; POCT based treatment PLUS

addressing psycholsocial problems OTHER

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

Also known as: providing basic information on vaginal discharge and antibiotics

POCT based treatment PLUS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Vaginal discharge under investigation is restricted to genetic females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women presenting with vaginal discharge to gynecological outpatients

You may not qualify if:

• Minors below the age of 18 years.
• Any bleeding from the vagina.
• Suspicion of gynecological cancer.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Kathmandu University School of Medical Sciences: collaborator
• University of Oslo: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Kavre, Nepal

Location

Related Publications (1)

• Shrestha S, Shakya S, Infanti JJ, Skovlund E, Simpson MR, Lonnee-Hoffmann RAM. Implementing point-of-care tests to optimize antibiotic use for vaginal discharge: a study protocol for a randomized controlled trial in Nepal. Trials. 2025 Dec 12;27(1):41. doi: 10.1186/s13063-025-09333-4.

  PMID: 41388307 DERIVED

MeSH Terms

Conditions

Vaginal Discharge; Sexually Transmitted Diseases; Anxiety Disorders; Depression; Vaginosis, Bacterial

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Risa AM Lonnee-Hoffmann, PhD

  Norwegian University for Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The health care provider will know if informed about the POCT results (in groups 2,3) or not (group 1). He will not know if patient is in group 2 or 3. The investigator will be present at various times during inclusion for quality control and therefore is not blinded. The outcome assessor ( the PhD candidate and the statistician) will receive data files without specific group label.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three armed RCT. 1. Standard treatment 2. POCT result based treatment 3. POCT result based treatment plus patient education and addressing of anxiety, depression and domestic violence

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: August 4, 2023
• Study Start: April 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 25, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. For five years
• Access Criteria: To researchers who submit a sound proposal. Proposals should be directed to risa.lonnee-hoffmann@ntnu.no. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Linkto be included).

Locations

NE (1)