xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977491</url>
    </required_header>
    <id_info>
      <org_study_id>335889</org_study_id>
      <nct_id>NCT05977491</nct_id>
    </id_info>
    <brief_title>Point-of-care Tests for Vaginal Discharge in Nepal</brief_title>
    <acronym>POCT-BRA</acronym>
    <official_title>Randomized Controlled Trial in Nepal: Introducing Point-of-care Tests and Identifying Barriers to Reduce Antibiotics for Vaginal Discharge</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Norwegian University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kathmandu University School of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Oslo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universiteit Antwerpen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Norwegian University of Science and Technology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to examine if and how the implementation of point-of&#xD;
        care-tests (POCT) for sexually transmitted infections in the management of abnormal vaginal&#xD;
        discharge reduces the overtreatment with antibiotics in a low income country. The setting is&#xD;
        a university hospital in a semi-rural area in Nepal and several of its rural&#xD;
        out-reach-centers. The plan is to include 1500 women attending the gynecological outpatients&#xD;
        with a problem of vaginal discharge over approximately a one year period.&#xD;
  &#xD;
        The main questions the clinical trial aims to answer are:&#xD;
  &#xD;
          -  Does POCT guided treatment result in reduced overtreatment of antibiotics, compared to&#xD;
             the current approach in Nepal?&#xD;
  &#xD;
          -  What are the barriers and facilitators of the acceptability of POCTs and the resulting&#xD;
             treatment from the perspective of both patients and health care practitioners?&#xD;
  &#xD;
        Participants will be randomised in three groups:&#xD;
  &#xD;
          -  standard treatment according to current practice&#xD;
  &#xD;
          -  POCT result based treatment&#xD;
  &#xD;
          -  POCT result based treatment plus patient education and addressing of psychosocial&#xD;
             vulnerabilities&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Abnormal vaginal discharge (AVD) is a common problem women seek treatment for allover the&#xD;
        world. In low and low- middle income countries (LLMICs) about one third of these women will&#xD;
        have a sexually transmitted disease (STI) caused by Chlamydia trachomatis (CT), Neisseria&#xD;
        gonorrhoea (NG) or Trichomonal vaginalis (TV). Approximately another third will have an&#xD;
        imbalance in the vaginal microbiotic flora, bacterial vaginosis (BV). These women and their&#xD;
        sexual partners in the case of sexually transmitted diseases will benefit from specific&#xD;
        antibiotic treatment. The last third of women will not have any infection and there are&#xD;
        indications that psychosocial problems may be expressed as somatic complaints, for example of&#xD;
        abnormal vaginal discharge in some cultures.&#xD;
  &#xD;
        In high income countries, with the help of laboratory-based tests, available after few days,&#xD;
        treatment is usually with a narrow spectrum antibiotic for specific bacteria. This involves&#xD;
        less risk for the development of antibiotic resistance. In low-income countries, laboratory&#xD;
        testing is not feasible due to costs and logistics. Women are usually receiving antibiotic&#xD;
        treatment with several types of antibiotics to cover STIs. More recently, point-of -care&#xD;
        tests which are nearly as accurate as laboratory-based tests have been developed.&#xD;
        Implementation studies for these tests in LLMICs are lacking. However, these molecular tests&#xD;
        are still expensive.&#xD;
  &#xD;
        In this study the investigators propose a combination of molecular tests for the two most&#xD;
        serious infections (CT and NG) and a cheap and simple test for TV and BV, which both are&#xD;
        treated with the same type of antibiotic.&#xD;
  &#xD;
        In addition, women attending an outpatient department in a LLMIC setting, expect (antibiotic)&#xD;
        treatment, which they will not receive with a negative POCT. In LLMICs it is common practice&#xD;
        to purchase over the counter medication, inclusive antibiotics. In particular for women with&#xD;
        negative POCT results, there could be a lack of adherence to treatment recommendations.&#xD;
  &#xD;
        We want to examine the following research questions (RQ) in the context of treatment for&#xD;
        vaginal discharge:&#xD;
  &#xD;
          1. Can POCTs effectively reduce the use of antibiotics? A) The amount of antibiotics&#xD;
             prescribed at the time of the appointment B) Additional antibiotics used, as reported by&#xD;
             the patients,&#xD;
  &#xD;
          2. Barriers and facilitators for patients and health practitioners with a focus on&#xD;
             psychosocial and educational elements&#xD;
  &#xD;
        For this purpose, a RCT with three arms was designed:&#xD;
  &#xD;
        (A) Treatment as usual, (B) Treatment according to POCT results, (C) Treatment according to&#xD;
        POCT results and additional patient information on vaginal discharge and antibiotics and&#xD;
        screening for and attention by the attending health care practitioner to psychosocial&#xD;
        problems.&#xD;
  &#xD;
        The investigators plan to include 1500 women with the complaint of abnormal vaginal during a&#xD;
        10-12 month period at Dhulikhel hospital, a tertiary university hospital in central Nepal and&#xD;
        selected outreach centers in 2024.&#xD;
  &#xD;
        Sample size calculation are based on RQ1 and RQ2, feasibility of recruitment and the&#xD;
        precision of the estimates, a two-sided 95 % confidence intervals (CI). For RQ1, the use of&#xD;
        any antibiotics will be assessed in both POCT arms combined versus the treatment as usual arm&#xD;
        (n = 1500), whilst the effect of the educational material on the use of over-the-counter&#xD;
        medications will be assessed in the POCTplus versus the POCT group (n = 1000). As many as 85%&#xD;
        of women with AVD are overtreated with antibiotics in LLMICs, around 50 % receive&#xD;
        antimicrobial resistance driving antibiotics and it is expected, that around 40 % women in&#xD;
        the POCT group will subsequently seek over the counter antibiotics. With 1500 participants&#xD;
        randomized 1:1:1, a 10 to 20 percentage point reduction in any of these measures will produce&#xD;
        CIs with a width between 8 and 12 % and at least 90% power. When allowing for around 40 %&#xD;
        loss to follow-up, when assessing the use of over-the-counter antibiotics, the expected width&#xD;
        of the CI is still around 15 %.&#xD;
  &#xD;
        The investigators will collect self-sampled urine and vaginal swabs from all included women&#xD;
        and a self-administered questionnaire with a color-coded audio-computer. The questionnaire&#xD;
        contains demographic information and a validated tool to screen for anxiety, depression and&#xD;
        domestic violence.&#xD;
  &#xD;
        Gold standard testing for the STIs and BV will be performed on all women. Participants will&#xD;
        be randomized into three arms. In the standard treatment arm, the attending health&#xD;
        practitioner will not be informed about POCT results. In the two POCT arms, the health care&#xD;
        practitioner will be informed about CT and NG status and about the pH, inclusive a&#xD;
        confirmatory whiff test.&#xD;
  &#xD;
        In the POCT-PLUS arm, patients will receive additional educational information about&#xD;
        physiological and abnormal vaginal discharge and about potentially negative effects of&#xD;
        antibiotic treatment. In this arm, health care practitioners will be informed if the woman&#xD;
        screened positive for anxiety, depression or domestic violence.&#xD;
  &#xD;
        Participants will be followed up telephonically after 1 and 4 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Three armed RCT.&#xD;
  Standard treatment&#xD;
  POCT result based treatment&#xD;
  POCT result based treatment plus patient education and addressing of anxiety, depression and domestic violence</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <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.&#xD;
  The investigator will be present at various times during inclusion for quality control and therefore is not blinded.&#xD;
  The outcome assessor ( the PhD candidate and the statistician) will receive data files without specific group label.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Amount of prescribed antibiotics (excluding antifungals)</measure>
      <time_frame>At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antimicrobial resistance driving antibiotics prescribed</measure>
      <time_frame>At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to treatment recommendations</measure>
      <time_frame>At telephonic follow up after 1 month.</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to treatment recommendations</measure>
      <time_frame>At telephonic follow up after 4 months</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correct antibiotic treatment</measure>
      <time_frame>At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect of educational measures on over the counter acquisition of medication</measure>
      <time_frame>At follow up 1 and 4 months after initial consultation</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of screening for anxiety and depression on over the counter acquisition of medication</measure>
      <time_frame>At follow up 1 and 4 months after initial consultation</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of addressing domestic violence on over the counter acquisition of medication</measure>
      <time_frame>At follow up 1 and 4 months after initial consultation</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>At follow up after 4 months</time_frame>
      <description>Satisfaction with consultation and treatment on a scale from 1-10</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Vaginal Discharge</condition>
    <condition>Sexually Transmitted Diseases</condition>
    <arm_group>
      <arm_group_label>Standard treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>POCT based treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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).&#xD;
  Examination of the patient is performed according to the discretion of the health care practitioner.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>POCT based treatment PLUS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Same as in POCT based treatment PLUS:&#xD;
  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.&#xD;
  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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Health care practitioner is informed of POCT results for CT and NG</intervention_name>
      <description>Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative</description>
      <arm_group_label>POCT based treatment</arm_group_label>
      <arm_group_label>POCT based treatment PLUS</arm_group_label>
      <other_name>GeneXpert test from Cepheid for CT andNG</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Health care practitioner is informed about POCT result for TV and BV</intervention_name>
      <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.</description>
      <arm_group_label>POCT based treatment</arm_group_label>
      <arm_group_label>POCT based treatment PLUS</arm_group_label>
      <other_name>Narrow range pH and confirmatory whiff test with potassium hydroxide (KHO), Amsel criteria</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Health care practitioner is informed on result for anxiety, depression,domestic violence screening</intervention_name>
      <description>The research assistant will inform the health care practitioner if screening positive for anxiety, depression or domestic violence.</description>
      <arm_group_label>POCT based treatment PLUS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women presenting with vaginal discharge to gynecological outpatients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Minors below the age of 18 years.&#xD;
  &#xD;
            -  Any bleeding from the vagina.&#xD;
  &#xD;
            -  Suspicion of gynecological cancer.&#xD;
  &#xD;
            -  Previous inclusion in the same study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Vaginal discharge under investigation is restricted to genetic females.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Risa AM Lonnee-Hoffmann, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Norwegian University for Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Risa AM Lonnee-Hoffmann, PhD</last_name>
      <phone>004741482354</phone>
      <email>risa.lonnee-hoffmann@ntnu.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sunila Shakya, PhD</last_name>
      <phone>009779803972599</phone>
      <email>sunilashakya@kusms.edu.np</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>antibiotic overtreatment</keyword>
    <keyword>psychosomatic</keyword>
    <keyword>domestic violence</keyword>
    <keyword>anxiety and depression</keyword>
    <keyword>chlamydia trachomatis</keyword>
    <keyword>neisseria gonorrhoea</keyword>
    <keyword>trichomonas vaginalis</keyword>
    <keyword>bacterial vaginosis</keyword>
    <keyword>process evaluation</keyword>
    <keyword>point-of-care-test</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sexually Transmitted Diseases</mesh_term>
      <mesh_term>Vaginal Discharge</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in the applicable article, after deidentification (without participant number) (text, tables, figures,and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Immediately following publication. For five years</ipd_time_frame>
      <ipd_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_access_criteria>
      <ipd_url>http://dataarkivering.sikt.no/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977491
  org study id: 335889
  nct id: NCT05977491
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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
  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:
  
          1. 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,
  
          2. 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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
  primary purpose: Other
  masking: Double (Participant, Outcomes 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.
  measure: Amount of prescribed antibiotics (excluding antifungals)
  time frame: At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.
  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.
  measure: Antimicrobial resistance driving antibiotics prescribed
  time frame: At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.
  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.
  measure: Adherence to treatment recommendations
  time frame: At telephonic follow up after 1 month.
  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.
  measure: Adherence to treatment recommendations
  time frame: At telephonic follow up after 4 months
  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.
  measure: Correct antibiotic treatment
  time frame: At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial.
  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.
  measure: Effect of educational measures on over the counter acquisition of medication
  time frame: At follow up 1 and 4 months after initial consultation
  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.
  measure: Effect of screening for anxiety and depression on over the counter acquisition of medication
  time frame: At follow up 1 and 4 months after initial consultation
  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.
  measure: Effect of addressing domestic violence on over the counter acquisition of medication
  time frame: At follow up 1 and 4 months after initial consultation
  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.
  measure: Patient satisfaction
  time frame: At follow up after 4 months
  description: Satisfaction with consultation and treatment on a scale from 1-10
  arm group label: Standard treatment
  arm group type: No Intervention
  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 group label: POCT based treatment
  arm group type: Active Comparator
  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 group label: POCT based treatment PLUS
  arm group type: Active Comparator
  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: Health care practitioner is informed of POCT results for CT and NG
  description: Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative
  arm group label: POCT based treatment
  arm group label: POCT based treatment PLUS
  other name: GeneXpert test from Cepheid for CT andNG
  intervention type: Diagnostic Test
  intervention name: Health care practitioner is informed about POCT result for TV and BV
  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.
  arm group label: POCT based treatment
  arm group label: POCT based treatment PLUS
  other name: Narrow range pH and confirmatory whiff test with potassium hydroxide (KHO), Amsel criteria
  intervention type: Other
  intervention name: Health care practitioner is informed on result for anxiety, depression,domestic violence screening
  description: The research assistant will inform the health care practitioner if screening positive for anxiety, depression or domestic violence.
  arm group label: POCT based treatment PLUS
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Vaginal discharge under investigation is restricted to genetic females.
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Risa AM Lonnee-Hoffmann, PhD
  role: Principal Investigator
  affiliation: Norwegian University for Science and Technology
  last name: Risa AM Lonnee-Hoffmann, PhD
  phone: 004741482354
  email: risa.lonnee-hoffmann@ntnu.no
  last name: Sunila Shakya, PhD
  phone: 009779803972599
  email: sunilashakya@kusms.edu.np
  responsible party type: Sponsor
  mesh term: Sexually Transmitted Diseases
  mesh term: Vaginal Discharge
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in the applicable article, after deidentification (without participant number) (text, tables, figures,and appendices).
  ipd info type: Study Protocol
  ipd time frame: Immediately following publication. For five years
  ipd 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 url: http://dataarkivering.sikt.no/