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Point-of-care Tests for Vaginal Discharge in Nepal (POCT-BRA)

Primary Purpose

Vaginal Discharge, Sexually Transmitted Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health care practitioner is informed of POCT results for CT and NG
Health care practitioner is informed about POCT result for TV and BV
Health care practitioner is informed on result for anxiety, depression,domestic violence screening
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaginal Discharge focused on measuring antibiotic overtreatment, psychosomatic, domestic violence, anxiety and depression, chlamydia trachomatis, neisseria gonorrhoea, trichomonas vaginalis, bacterial vaginosis, process evaluation, point-of-care-test

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    Standard treatment

    POCT based treatment

    POCT based treatment PLUS

    Arm Description

    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.

    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). Examination of the patient is performed according to the discretion of the health care practitioner.

    Same as in POCT based treatment PLUS: 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. All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, the health care practitioner will be informed, in addition to the POCT result.

    Outcomes

    Primary Outcome Measures

    Amount of prescribed antibiotics (excluding antifungals)
    Comparing the proportion of women prescribed antibiotics for treatment in total and in subgroups, depending if the health care practitioner was informed about the POCT results. Self reported by the health care practitioner. Subgroups: Doxycycline, Tetracycline, Ciprofloxacin, Azithromycin or Trimethoprim(sulfa), Metronidazole, Cephalosporin, other antibiotics.
    Antimicrobial resistance driving antibiotics prescribed
    Comparing the proportion of women prescribed antimicrobial resistance driving antibiotics, in total and in subgroups (Cephalosporins, Azithromycin, Ciprofloxacin), depending if the health care practitioner was informed about the POCT results. Reported by health care practitioner.
    Adherence to treatment recommendations
    Comparing the proportion of women reporting acquisition of self reported over the counter medication in total and subgroups (antibiotics, painkillers, others, unknown type) for the three different RCT arms.
    Adherence to treatment recommendations
    Comparing the proportion of women reporting acquisition of over the counter medication in total and subgroups (antibiotics, painkillers, others, unknown type) for the three different RCT arms.
    Correct antibiotic treatment
    Comparing the proportion of women receiving correct antibiotic treatment for a Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis infection or for bacterial vaginosis, depending if the health practitioner received POCT results.

    Secondary Outcome Measures

    Effect of educational measures on over the counter acquisition of medication
    Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if they received education on vaginal discharge and antibiotics. Subgroups: Antibiotics, painkillers, others, unknown type.
    Effect of screening for anxiety and depression on over the counter acquisition of medication
    Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if the health practitioner was informed about a positive anxiety or depression screen. Subgroups: Antibiotics, painkillers, others, unknown type.
    Effect of addressing domestic violence on over the counter acquisition of medication
    Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if the health practitioner was informed about a history of domestic violence. Subgroups: Antibiotics, painkillers, others, unknown type.
    Patient satisfaction
    Satisfaction with consultation and treatment on a scale from 1-10

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Norwegian University of Science and Technology
    Collaborators
    Kathmandu University School of Medical Sciences, University of Oslo, Universiteit Antwerpen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05977491
    Brief Title
    Point-of-care Tests for Vaginal Discharge in Nepal
    Acronym
    POCT-BRA
    Official Title
    Randomized Controlled Trial in Nepal: Introducing Point-of-care Tests and Identifying Barriers to Reduce Antibiotics for Vaginal Discharge
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    Collaborators
    Kathmandu University School of Medical Sciences, University of Oslo, Universiteit Antwerpen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 overtreatment 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 randomised in three groups: standard treatment according to current practice POCT result based treatment POCT result based treatment plus patient education and addressing of psychosocial vulnerabilities
    Detailed Description
    Abnormal vaginal discharge (AVD) is a common problem women seek treatment for allover the world. In low and low- middle income countries (LLMICs) about one third of these women will have a sexually transmitted disease (STI) caused by Chlamydia trachomatis (CT), Neisseria gonorrhoea (NG) or Trichomonal vaginalis (TV). Approximately another third will have an imbalance in the vaginal microbiotic flora, bacterial vaginosis (BV). These women and their sexual partners in the case of sexually transmitted diseases will benefit from specific antibiotic treatment. The last third of women will not have any infection and there are indications that psychosocial problems may be expressed as somatic complaints, for example of abnormal vaginal discharge in some cultures. In high income countries, with the help of laboratory-based tests, available after few days, treatment is usually with a narrow spectrum antibiotic for specific bacteria. This involves less risk for the development of antibiotic resistance. In low-income countries, laboratory testing is not feasible due to costs and logistics. Women are usually receiving antibiotic treatment with several types of antibiotics to cover STIs. More recently, point-of -care tests which are nearly as accurate as laboratory-based tests have been developed. Implementation studies for these tests in LLMICs are lacking. However, these molecular tests are still expensive. In this study the investigators propose a combination of molecular tests for the two most serious infections (CT and NG) and a cheap and simple test for TV and BV, which both are treated with the same type of antibiotic. In addition, women attending an outpatient department in a LLMIC setting, expect (antibiotic) treatment, which they will not receive with a negative POCT. In LLMICs it is common practice to purchase over the counter medication, inclusive antibiotics. In particular for women with negative POCT results, there could be a lack of adherence to treatment recommendations. We want to examine the following research questions (RQ) in the context of treatment for vaginal discharge: Can POCTs effectively reduce the use of antibiotics? A) The amount of antibiotics prescribed at the time of the appointment B) Additional antibiotics used, as reported by the patients, Barriers and facilitators for patients and health practitioners with a focus on psychosocial and educational elements For this purpose, a RCT with three arms was designed: (A) Treatment as usual, (B) Treatment according to POCT results, (C) Treatment according to POCT results and additional patient information on vaginal discharge and antibiotics and screening for and attention by the attending health care practitioner to psychosocial problems. The investigators plan to include 1500 women with the complaint of abnormal vaginal during a 10-12 month period at Dhulikhel hospital, a tertiary university hospital in central Nepal and selected outreach centers in 2024. Sample size calculation are based on RQ1 and RQ2, feasibility of recruitment and the precision of the estimates, a two-sided 95 % confidence intervals (CI). For RQ1, the use of any antibiotics will be assessed in both POCT arms combined versus the treatment as usual arm (n = 1500), whilst the effect of the educational material on the use of over-the-counter medications will be assessed in the POCTplus versus the POCT group (n = 1000). As many as 85% of women with AVD are overtreated with antibiotics in LLMICs, around 50 % receive antimicrobial resistance driving antibiotics and it is expected, that around 40 % women in the POCT group will subsequently seek over the counter antibiotics. With 1500 participants randomized 1:1:1, a 10 to 20 percentage point reduction in any of these measures will produce CIs with a width between 8 and 12 % and at least 90% power. When allowing for around 40 % loss to follow-up, when assessing the use of over-the-counter antibiotics, the expected width of the CI is still around 15 %. The investigators will collect self-sampled urine and vaginal swabs from all included women and a self-administered questionnaire with a color-coded audio-computer. The questionnaire contains demographic information and a validated tool to screen for anxiety, depression and domestic violence. Gold standard testing for the STIs and BV will be performed on all women. Participants will be randomized into three arms. In the standard treatment arm, the attending health practitioner will not be informed about POCT results. In the two POCT arms, the health care practitioner will be informed about CT and NG status and about the pH, inclusive a confirmatory whiff test. In the POCT-PLUS arm, patients will receive additional educational information about physiological and abnormal vaginal discharge and about potentially negative effects of antibiotic treatment. In this arm, health care practitioners will be informed if the woman screened positive for anxiety, depression or domestic violence. Participants will be followed up telephonically after 1 and 4 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Three armed RCT. Standard treatment POCT result based treatment POCT result based treatment plus patient education and addressing of anxiety, depression and domestic violence
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard treatment
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    POCT based treatment
    Arm Type
    Active Comparator
    Arm Description
    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). Examination of the patient is performed according to the discretion of the health care practitioner.
    Arm Title
    POCT based treatment PLUS
    Arm Type
    Active Comparator
    Arm Description
    Same as in POCT based treatment PLUS: 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. All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, the health care practitioner will be informed, in addition to the POCT result.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Health care practitioner is informed of POCT results for CT and NG
    Other Intervention Name(s)
    GeneXpert test from Cepheid for CT andNG
    Intervention Description
    Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Health care practitioner is informed about POCT result for TV and BV
    Other Intervention Name(s)
    Narrow range pH and confirmatory whiff test with potassium hydroxide (KHO), Amsel criteria
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Health care practitioner is informed on result for anxiety, depression,domestic violence screening
    Intervention Description
    The research assistant will inform the health care practitioner if screening positive for anxiety, depression or domestic violence.
    Primary Outcome Measure Information:
    Title
    Amount of prescribed antibiotics (excluding antifungals)
    Description
    Comparing the proportion of women prescribed antibiotics for treatment in total and in subgroups, depending if the health care practitioner was informed about the POCT results. Self reported by the health care practitioner. Subgroups: Doxycycline, Tetracycline, Ciprofloxacin, Azithromycin or Trimethoprim(sulfa), Metronidazole, Cephalosporin, other antibiotics.
    Time Frame
    At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.
    Title
    Antimicrobial resistance driving antibiotics prescribed
    Description
    Comparing the proportion of women prescribed antimicrobial resistance driving antibiotics, in total and in subgroups (Cephalosporins, Azithromycin, Ciprofloxacin), depending if the health care practitioner was informed about the POCT results. Reported by health care practitioner.
    Time Frame
    At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.
    Title
    Adherence to treatment recommendations
    Description
    Comparing the proportion of women reporting acquisition of self reported over the counter medication in total and subgroups (antibiotics, painkillers, others, unknown type) for the three different RCT arms.
    Time Frame
    At telephonic follow up after 1 month.
    Title
    Adherence to treatment recommendations
    Description
    Comparing the proportion of women reporting acquisition of over the counter medication in total and subgroups (antibiotics, painkillers, others, unknown type) for the three different RCT arms.
    Time Frame
    At telephonic follow up after 4 months
    Title
    Correct antibiotic treatment
    Description
    Comparing the proportion of women receiving correct antibiotic treatment for a Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis infection or for bacterial vaginosis, depending if the health practitioner received POCT results.
    Time Frame
    At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.
    Secondary Outcome Measure Information:
    Title
    Effect of educational measures on over the counter acquisition of medication
    Description
    Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if they received education on vaginal discharge and antibiotics. Subgroups: Antibiotics, painkillers, others, unknown type.
    Time Frame
    At follow up 1 and 4 months after initial consultation
    Title
    Effect of screening for anxiety and depression on over the counter acquisition of medication
    Description
    Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if the health practitioner was informed about a positive anxiety or depression screen. Subgroups: Antibiotics, painkillers, others, unknown type.
    Time Frame
    At follow up 1 and 4 months after initial consultation
    Title
    Effect of addressing domestic violence on over the counter acquisition of medication
    Description
    Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if the health practitioner was informed about a history of domestic violence. Subgroups: Antibiotics, painkillers, others, unknown type.
    Time Frame
    At follow up 1 and 4 months after initial consultation
    Title
    Patient satisfaction
    Description
    Satisfaction with consultation and treatment on a scale from 1-10
    Time Frame
    At follow up after 4 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Vaginal discharge under investigation is restricted to genetic females.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Risa AM Lonnee-Hoffmann, PhD
    Phone
    004741482354
    Email
    risa.lonnee-hoffmann@ntnu.no
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sunila Shakya, PhD
    Phone
    009779803972599
    Email
    sunilashakya@kusms.edu.np
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Risa AM Lonnee-Hoffmann, PhD
    Organizational Affiliation
    Norwegian University for Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data that underlie the results reported in the applicable article, after deidentification (without participant number) (text, tables, figures,and appendices).
    IPD Sharing Time Frame
    Immediately following publication. For five years
    IPD Sharing 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).
    IPD Sharing URL
    http://dataarkivering.sikt.no/

    Learn more about this trial

    Point-of-care Tests for Vaginal Discharge in Nepal

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