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/NCT05994495</url>
    </required_header>
    <id_info>
      <org_study_id>MHREC2023-97</org_study_id>
      <nct_id>NCT05994495</nct_id>
    </id_info>
    <brief_title>Utility and Acceptability of a Molecular Test in the Management of Sexually Transmitted Diseases in Uganda</brief_title>
    <acronym>ASTRHA</acronym>
    <official_title>Utility, Acceptability and Applicability of a Nucleic Acid Amplification Test (NAAT) in Comparison With Syndromic Approach in the Management of Sexually Transmitted Diseases at Mulago National Referral Hospital in Uganda</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riccardo Serraino</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Societa' Italiana Di Malattie Infettive E Tropicali</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Azienda Ospedaliera Universitaria Mater Domini, Catanzaro</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess utility and acceptability of a molecular test in&#xD;
        comparison with clinical syndromic approach in the management of sexually transmitted&#xD;
        diseases (STD) at STD clinic of Mulago National Referral Hospital in Uganda.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does new molecular test improve appropriateness of therapy compared with the clinical&#xD;
             syndromic approach without or with limited laboratory tests in the management of STDs?&#xD;
  &#xD;
          -  Are new molecular tests both clinically useful and acceptable in a Low-Middle Income&#xD;
             Country for the management of STDs?&#xD;
  &#xD;
        Participants will be put into two groups (&quot;A&quot; or &quot;B&quot;):&#xD;
  &#xD;
          -  Participants in group &quot;A&quot; will have a pus swab collected from urethra or vagina or a&#xD;
             urine sample. After the result of the test, patients will be prescribed a specific drug.&#xD;
  &#xD;
          -  Participants in group &quot;B&quot; will have a pus swab collected from urethra or vagina or a&#xD;
             urine sample, but participants in group &quot;B&quot; and their doctor will not know the results&#xD;
             of the test. So, participants in group &quot;B&quot; will be given treatment in the standard way,&#xD;
             according to the current clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sexually transmitted diseases (STDs) are a major cause of long-term disability. Urethral&#xD;
        discharge syndrome (UDS), abnormal vaginal discharge (AVD) and genital ulcer disease (GUD)&#xD;
        are very common syndromes in low- and middle-income countries where, due to lack of&#xD;
        resources, these syndromes are managed according to a syndromic approach. Appropriate STD&#xD;
        diagnosis and treatment are crucial to prevent the transmission and sequelae. No randomized&#xD;
        trials have been conducted so far to evaluate clinical usefulness and acceptability of&#xD;
        microbiological diagnosis using NAAT in comparison with syndromic approach.&#xD;
  &#xD;
        The aims of the study is to evaluate the clinical usefulness of a NAAT in terms of&#xD;
        appropriateness of therapy, clinical and microbiological outcomes, diagnostic accuracy, and&#xD;
        acceptability in comparison with syndromic approach and to explore whether this test could&#xD;
        replace the syndromic approach in the management of STDs at a National Referral Hospital in&#xD;
        Uganda. At last, to estimate the actual prevalence of causative agents of STDs in this&#xD;
        setting.&#xD;
  &#xD;
        In summary final aim is that the results could inform diagnostic guidelines since they may&#xD;
        suggest an update of the current recommendations. Investigators speculate that the change in&#xD;
        approach would allow a significant improvement in terms of appropriateness of therapy,&#xD;
        reduction of the collateral damage, toxicity, and pharmacoeconomics costs.&#xD;
  &#xD;
        This is an operational, randomized, open-label trial. Patients will be randomized (using&#xD;
        block computerized method) into two Arms (&quot;A&quot; or &quot;B&quot;). Patients randomized to Arm &quot;A&quot; will be&#xD;
        subjected to a microbiological test (either swabs or urine testing by NAAT). After having&#xD;
        obtained the result of the molecular test, patients will be prescribed a targeted treatment.&#xD;
        Patients randomized to Arm &quot;B&quot; will be subjected to a molecular test, but they will be&#xD;
        treated according to the current guidelines and the best practice using the clinical&#xD;
        syndromic approach. So, patients randomized to Arm &quot;B&quot; and their physician also will be&#xD;
        blinded to the results of the molecular test. All the patients randomized to Arm &quot;A&quot; or to&#xD;
        Arm &quot;B&quot; will be asked to return after two-three weeks for a control visit. The NAAT test will&#xD;
        be performed with Bosch Vivalytic Sexually Transmitted Infection test.&#xD;
  &#xD;
        STUDY POPULATION Adults aged 18 years and above presenting with signs and symptoms of STDs at&#xD;
        the Mulago Hospital STDs clinic during the study period, who provide written consent to the&#xD;
        participation to the study and are diagnosed with UDS, AVD and GUD. Persons belonging to&#xD;
        special populations (i.e., female sex workers, MSM) will be analyzed separately.&#xD;
  &#xD;
        SAMPLE SIZE Eighty-seven patients (rounded to 90) in each treatment arm are necessary for&#xD;
        demonstrating a difference of 0.20 by means of the Fisher's exact test carried out at a&#xD;
        significance level of 0.05 (two tailed). The sample size will be increased to 110 patients in&#xD;
        each treatment arm for allowing a drop- out rate of about 20%.&#xD;
  &#xD;
        SAMPLING METHOD Two groups will be created by a random process and a blinded intervention.&#xD;
        The intended sample will be composed by all sequential patients presenting with signs or&#xD;
        symptoms suggestive for STDs at the time of screening for inclusion into the trial. Only&#xD;
        patients who will satisfy the inclusion and exclusion criteria will be randomized after&#xD;
        signing the informed consent. The randomization process will be carried out according to a&#xD;
        complete block model. In addition, randomization will be stratified by gender. Any efforts&#xD;
        will be put into improving the internal and external validity of the trial.&#xD;
  &#xD;
        Data will be collected in an anonymized form: an Identification number will be assigned to&#xD;
        each patients. Data will be analyzed by statistical team which will be led by a senior&#xD;
        statistician&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>This is an operational, randomized, open-label trial to assess appropriateness of therapy, diagnostic accuracy, clinical and microbiological outcomes, and acceptability of an etiology approach using a molecular test (NAAT) versus a clinical syndromic approach for the management of STDs in patients followed by a STD clinic of a National Referral Hospital in Kampala, Uganda.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical Usefulness</measure>
      <time_frame>minutes 210</time_frame>
      <description>Proportion of patients with appropriate therapy in each arm. Appropriate therapy will be defined (either as study intervention during consultation in Arm &quot;A&quot; or post-hoc in Arm &quot;B&quot;) as the use of a recommended drug or drug combinations which are recommended against the pathogen(s) diagnosed by the molecular test.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Microbiological and clinical cure</measure>
      <time_frame>weeks 3</time_frame>
      <description>Microbiological cure measured as the percentage of patients who will achieve success at the test of cure performed after two-three weeks from the end of therapy in both arms. For the clinical outcome, we will consider the percentage of patients who will recover from signs and symptoms of the STDs in both arms at the same time-point.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concordance</measure>
      <time_frame>Minutes 210</time_frame>
      <description>Percentage of concordant results between the syndromic approach and the NAAT. The diagnosis is considered concordant when at least one pathogen responsible for a specific syndrome (Table 1) diagnosed through the syndromic approach is detected by a molecular testing. The diagnosis is considered not concordant when one or more pathogens responsible for syndromes other than those identified by the syndromic approach, are detected by molecular testing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability</measure>
      <time_frame>Minutes 210</time_frame>
      <description>Percentage of patients who will be sent home the same day with the treatment prescribed according to the molecular test result (Arm &quot;A&quot;) or with the treatment according to the syndromic approach (Arm &quot;B&quot;). Patients will not be able to wait for the result of the test and for the targeted therapy will be considered as failure for the primary endpoint. In addition, patients who will drop out from the study will be considered as failure.&#xD;
  Percentage of patients who will be sent home the same day with the treatment prescribed according to the molecular test result (Arm &quot;A&quot;) or with the treatment according to the syndromic approach (Arm &quot;B&quot;). Patients will not be able to wait for the result of the test and for the targeted therapy will be considered as failure for the primary endpoint. In addition, patients who will drop out from the study will be considered as failure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence</measure>
      <time_frame>Months 2</time_frame>
      <description>Prevalence of detected pathogens' genome at the molecular test (overall population).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Sexually Transmitted Diseases</condition>
    <arm_group>
      <arm_group_label>ARM A Molecular test</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to Arm &quot;A&quot; will be subjected to a microbiological test (either swabs or urine testing by NAAT). After having obtained the result of the molecular test, patients will be prescribed a targeted treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ARM B Clinical Syndromic Approach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients randomized to Arm &quot;B&quot; will be subjected to a molecular test, but they will be treated according to the current guidelines and the best practice using the clinical syndromic approach. So, patients randomized to Arm &quot;B&quot; and their physician also will be blinded to the results of the molecular test</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>nuclear acid amplification tests</intervention_name>
      <description>The NAAT test will be performed with Bosch Vivalytic STI test. It is a qualitative Polymerase Chain Reaction-based assay for simultaneous detection of 10 common sexually transmitted pathogens: Herpes simplex virus 1 (HSV 1)- Herpes simplex virus 2 (HSV 2)- Chlamydia trachomatis (CT) - Haemophilus ducreyi (HD)- Mycoplasma genitalium (MG) - Mycoplasma hominis (MH) - Neisseria gonorrhoeae (NG) - Treponema pallidum (TP)- Ureaplasma urealyticum (UU) - Trichomonas vaginalis (TV)</description>
      <arm_group_label>ARM A Molecular test</arm_group_label>
      <other_name>Bosch Vivalytic STI test</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical Syndromic Approach</intervention_name>
      <description>Physical examination</description>
      <arm_group_label>ARM B Clinical Syndromic Approach</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult males and females with UDS, AVD and GUD diagnosed as per the current National&#xD;
               STD Management Guidelines 201616, who have given informed, written, and signed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  All patients presenting with UDS, AVD and GUD who decline informed and written&#xD;
               consent.&#xD;
  &#xD;
                 -  All patients living farther than a 20 km radius from Mulago National Referral&#xD;
                    Hospital&#xD;
  &#xD;
                 -  All patients presenting with any syndromes not listed above.&#xD;
  &#xD;
                 -  Female patients in their menstrual period.&#xD;
  &#xD;
                 -  Pregnant patients.&#xD;
  &#xD;
                 -  Patients with a previous infection presenting with recurrence or relapse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Carlo Torti</last_name>
      <role>Principal Investigator</role>
      <affiliation>Magna Graecia University of Catanzaro, Italy</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Patrick Musinguzi</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mulago National Referral Hospital, Kampala, Uganda</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Riccardo Serraino</last_name>
      <phone>+39 3338468913</phone>
      <email>r.serraino1@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carlo Torti</last_name>
      <phone>+39 3394706981</phone>
      <email>torti@unicz.it</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Ospedaliera Universitaria Mater Domini, Catanzaro</investigator_affiliation>
      <investigator_full_name>Riccardo Serraino</investigator_full_name>
      <investigator_title>Fellow</investigator_title>
    </responsible_party>
    <keyword>Sexually transmitted diseases</keyword>
    <keyword>STDs</keyword>
    <keyword>Low-Middle Income Country</keyword>
    <keyword>Molecular Test</keyword>
    <keyword>NUCLEIC ACID AMPLIFICATION TEST</keyword>
    <keyword>NAAT</keyword>
    <keyword>Clinical Syndromic Approach</keyword>
    <keyword>LMIC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sexually Transmitted Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05994495
  org study id: MHREC2023-97
  nct id: NCT05994495
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess utility and acceptability of a molecular test in
        comparison with clinical syndromic approach in the management of sexually transmitted
        diseases (STD) at STD clinic of Mulago National Referral Hospital in Uganda.
  
        The main questions it aims to answer are:
  
          -  Does new molecular test improve appropriateness of therapy compared with the clinical
             syndromic approach without or with limited laboratory tests in the management of STDs?
  
          -  Are new molecular tests both clinically useful and acceptable in a Low-Middle Income
             Country for the management of STDs?
  
        Participants will be put into two groups ("A" or "B"):
  
          -  Participants in group "A" will have a pus swab collected from urethra or vagina or a
             urine sample. After the result of the test, patients will be prescribed a specific drug.
  
          -  Participants in group "B" will have a pus swab collected from urethra or vagina or a
             urine sample, but participants in group "B" and their doctor will not know the results
             of the test. So, participants in group "B" will be given treatment in the standard way,
             according to the current clinical practice.
  Sexually transmitted diseases (STDs) are a major cause of long-term disability. Urethral
        discharge syndrome (UDS), abnormal vaginal discharge (AVD) and genital ulcer disease (GUD)
        are very common syndromes in low- and middle-income countries where, due to lack of
        resources, these syndromes are managed according to a syndromic approach. Appropriate STD
        diagnosis and treatment are crucial to prevent the transmission and sequelae. No randomized
        trials have been conducted so far to evaluate clinical usefulness and acceptability of
        microbiological diagnosis using NAAT in comparison with syndromic approach.
  
        The aims of the study is to evaluate the clinical usefulness of a NAAT in terms of
        appropriateness of therapy, clinical and microbiological outcomes, diagnostic accuracy, and
        acceptability in comparison with syndromic approach and to explore whether this test could
        replace the syndromic approach in the management of STDs at a National Referral Hospital in
        Uganda. At last, to estimate the actual prevalence of causative agents of STDs in this
        setting.
  
        In summary final aim is that the results could inform diagnostic guidelines since they may
        suggest an update of the current recommendations. Investigators speculate that the change in
        approach would allow a significant improvement in terms of appropriateness of therapy,
        reduction of the collateral damage, toxicity, and pharmacoeconomics costs.
  
        This is an operational, randomized, open-label trial. Patients will be randomized (using
        block computerized method) into two Arms ("A" or "B"). Patients randomized to Arm "A" will be
        subjected to a microbiological test (either swabs or urine testing by NAAT). After having
        obtained the result of the molecular test, patients will be prescribed a targeted treatment.
        Patients randomized to Arm "B" will be subjected to a molecular test, but they will be
        treated according to the current guidelines and the best practice using the clinical
        syndromic approach. So, patients randomized to Arm "B" and their physician also will be
        blinded to the results of the molecular test. All the patients randomized to Arm "A" or to
        Arm "B" will be asked to return after two-three weeks for a control visit. The NAAT test will
        be performed with Bosch Vivalytic Sexually Transmitted Infection test.
  
        STUDY POPULATION Adults aged 18 years and above presenting with signs and symptoms of STDs at
        the Mulago Hospital STDs clinic during the study period, who provide written consent to the
        participation to the study and are diagnosed with UDS, AVD and GUD. Persons belonging to
        special populations (i.e., female sex workers, MSM) will be analyzed separately.
  
        SAMPLE SIZE Eighty-seven patients (rounded to 90) in each treatment arm are necessary for
        demonstrating a difference of 0.20 by means of the Fisher's exact test carried out at a
        significance level of 0.05 (two tailed). The sample size will be increased to 110 patients in
        each treatment arm for allowing a drop- out rate of about 20%.
  
        SAMPLING METHOD Two groups will be created by a random process and a blinded intervention.
        The intended sample will be composed by all sequential patients presenting with signs or
        symptoms suggestive for STDs at the time of screening for inclusion into the trial. Only
        patients who will satisfy the inclusion and exclusion criteria will be randomized after
        signing the informed consent. The randomization process will be carried out according to a
        complete block model. In addition, randomization will be stratified by gender. Any efforts
        will be put into improving the internal and external validity of the trial.
  
        Data will be collected in an anonymized form: an Identification number will be assigned to
        each patients. Data will be analyzed by statistical team which will be led by a senior
        statistician
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is an operational, randomized, open-label trial to assess appropriateness of therapy, diagnostic accuracy, clinical and microbiological outcomes, and acceptability of an etiology approach using a molecular test (NAAT) versus a clinical syndromic approach for the management of STDs in patients followed by a STD clinic of a National Referral Hospital in Kampala, Uganda.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Clinical Usefulness
  time frame: minutes 210
  description: Proportion of patients with appropriate therapy in each arm. Appropriate therapy will be defined (either as study intervention during consultation in Arm "A" or post-hoc in Arm "B") as the use of a recommended drug or drug combinations which are recommended against the pathogen(s) diagnosed by the molecular test.
  measure: Microbiological and clinical cure
  time frame: weeks 3
  description: Microbiological cure measured as the percentage of patients who will achieve success at the test of cure performed after two-three weeks from the end of therapy in both arms. For the clinical outcome, we will consider the percentage of patients who will recover from signs and symptoms of the STDs in both arms at the same time-point.
  measure: Concordance
  time frame: Minutes 210
  description: Percentage of concordant results between the syndromic approach and the NAAT. The diagnosis is considered concordant when at least one pathogen responsible for a specific syndrome (Table 1) diagnosed through the syndromic approach is detected by a molecular testing. The diagnosis is considered not concordant when one or more pathogens responsible for syndromes other than those identified by the syndromic approach, are detected by molecular testing.
  measure: Acceptability
  time frame: Minutes 210
  description: Percentage of patients who will be sent home the same day with the treatment prescribed according to the molecular test result (Arm "A") or with the treatment according to the syndromic approach (Arm "B"). Patients will not be able to wait for the result of the test and for the targeted therapy will be considered as failure for the primary endpoint. In addition, patients who will drop out from the study will be considered as failure.
  Percentage of patients who will be sent home the same day with the treatment prescribed according to the molecular test result (Arm "A") or with the treatment according to the syndromic approach (Arm "B"). Patients will not be able to wait for the result of the test and for the targeted therapy will be considered as failure for the primary endpoint. In addition, patients who will drop out from the study will be considered as failure.
  measure: Prevalence
  time frame: Months 2
  description: Prevalence of detected pathogens' genome at the molecular test (overall population).
  arm group label: ARM A Molecular test
  arm group type: Experimental
  description: Patients randomized to Arm "A" will be subjected to a microbiological test (either swabs or urine testing by NAAT). After having obtained the result of the molecular test, patients will be prescribed a targeted treatment
  arm group label: ARM B Clinical Syndromic Approach
  arm group type: Active Comparator
  description: Patients randomized to Arm "B" will be subjected to a molecular test, but they will be treated according to the current guidelines and the best practice using the clinical syndromic approach. So, patients randomized to Arm "B" and their physician also will be blinded to the results of the molecular test
  intervention type: Diagnostic Test
  intervention name: nuclear acid amplification tests
  description: The NAAT test will be performed with Bosch Vivalytic STI test. It is a qualitative Polymerase Chain Reaction-based assay for simultaneous detection of 10 common sexually transmitted pathogens: Herpes simplex virus 1 (HSV 1)- Herpes simplex virus 2 (HSV 2)- Chlamydia trachomatis (CT) - Haemophilus ducreyi (HD)- Mycoplasma genitalium (MG) - Mycoplasma hominis (MH) - Neisseria gonorrhoeae (NG) - Treponema pallidum (TP)- Ureaplasma urealyticum (UU) - Trichomonas vaginalis (TV)
  arm group label: ARM A Molecular test
  other name: Bosch Vivalytic STI test
  intervention type: Other
  intervention name: Clinical Syndromic Approach
  description: Physical examination
  arm group label: ARM B Clinical Syndromic Approach
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Carlo Torti
  role: Principal Investigator
  affiliation: Magna Graecia University of Catanzaro, Italy
  last name: Patrick Musinguzi
  role: Principal Investigator
  affiliation: Mulago National Referral Hospital, Kampala, Uganda
  last name: Riccardo Serraino
  phone: +39 3338468913
  email: r.serraino1@gmail.com
  last name: Carlo Torti
  phone: +39 3394706981
  email: torti@unicz.it
  responsible party type: Sponsor-Investigator
  investigator affiliation: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
  investigator full name: Riccardo Serraino
  investigator title: Fellow
  mesh term: Sexually Transmitted Diseases
  sharing ipd: No