<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/NCT01681914</url>
  </required_header>
  <id_info>
    <org_study_id>100803</org_study_id>
    <secondary_id>U2GPS000631-05</secondary_id>
    <nct_id>NCT01681914</nct_id>
  </id_info>
  <brief_title>Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique</brief_title>
  <official_title>Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique: A Country-specific Public Health Evaluation.&quot; (CDC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this&#xD;
      project seeks to assess the effectiveness of a subset of the new Mozambican clinical&#xD;
      guidelines for the diagnosis, initial management, and follow-up ( &gt;1 follow-up visit to&#xD;
      determine response to initial and/or second-line therapy) of common signs and symptoms in&#xD;
      HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in&#xD;
      MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the&#xD;
      new guidelines will be described; they will be compared to the previous standard of care for&#xD;
      the problem(s) of interest, and the clinical importance of differences between guidelines&#xD;
      designed for Mozambican non-physician clinicians and new guidelines (also issued in late&#xD;
      2009) for Mozambican physicians will be described. The subset of guidelines to be addressed&#xD;
      in the current phase of this 2-year project includes algorithms for diagnosis and management&#xD;
      of acute fever, persistent fever, and anemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1. What proportion of HIV-infected adult patients with common signs and symptoms can be assigned specific, potentially treatable diagnoses or syndromic classifications when evaluated in conformity with new Mozambican algorithms?</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>What proportion of HIV-infected adult patients with common signs and symptoms improve clinically when evaluated and managed in conformity with new Mozambican algorithms for técnicos de medicina?</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">492</enrollment>
  <condition>Anemia</condition>
  <condition>Fever</condition>
  <condition>HIV Positive</condition>
  <arm_group>
    <arm_group_label>Anemia</arm_group_label>
    <description>Ambulatory, HIV-infected adult patients with hemoglobin &lt;10 g/dL will be evaluated and managed in accordance with Mozambique's new anemia guideline for non-physician clinicians. The basic steps recommended by the guideline are: screen for danger signs and stabilize or admit if indicated; perform rapid malaria antigen test (and/or peripheral blood smear) and treat if indicated; evaluate for adverse drug reactions and manage per Mozambican national guidelines; consider nutritional deficiencies and intestinal parasites; evaluate response to therapy at &lt;=1 month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fever or History of Fever</arm_group_label>
    <description>Ambulatory, HIV-infected adult patients with measured axillary temperature &gt;=37.5 C or history of fever within the past 24 hours will be evaluated and managed in accordance with Mozambique's new fever guideline for non-physician clinicians. The basic steps of the fever guideline are: screen for danger signs and stabilize or admit if indicated; perform rapid malaria antigen test (and/or peripheral smear) and treat if indicated; treat any other cause of fever identified through history and physical examination; re-evaluate at next scheduled clinical visit (sooner if worse or if not improving within 48 hours of initiating treatment). Although blood cultures are seldom performed in Mozambican health centers, venipuncture specimens will also be cultured for bacterial pathogens at the first study visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anemia and Fever/History of Fever</arm_group_label>
    <description>Patients who meet eligibility criteria for both the anemia and fever arms will be evaluated and managed using both the new Mozambican anemia guideline and the new Mozambican fever guideline, as above.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of HIV-infected adult Mozambicans (age 18 years or over)&#xD;
        who receive ambulatory care at the Centro de Saúde (Health Center) of the 3 participating&#xD;
        health districts (Inhassunge, Namacurra and Maganja da Costa) in Zambézia Province. All 3&#xD;
        health centers have been providing ART for more than three years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years old&#xD;
&#xD;
          -  HIV-infected&#xD;
&#xD;
          -  Fever &gt; 37.5° C or history of fever&#xD;
&#xD;
          -  Anemia with recorded hemoglobin level &lt;10 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary language/dialect is not spoken or understood by any member of the study team.&#xD;
&#xD;
          -  Participants who meet algorithm-driven definitions of &quot;danger signs&quot; related to the&#xD;
             condition of interest at the time of screening&#xD;
&#xD;
          -  Pregnant women will be excluded only if they meet the following criteria (in labor, or&#xD;
             in need of emergency Caesarean section or dilatation and curettage)&#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>Paula E Brentlinger, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Friends in Global Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Troy Moon, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inhassunge District Health Facility</name>
      <address>
        <city>Inhassunge</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Namacurra District Health Facility</name>
      <address>
        <city>Namacurra</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coalane Health Facility</name>
      <address>
        <city>Quelimane</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mozambique</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>August 9, 2013</last_update_submitted>
  <last_update_submitted_qc>August 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Troy Moon</investigator_full_name>
    <investigator_title>Assistant Professor Department of Pediatric Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>adult HIV positive patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01681914
org study id: 100803
secondary id: U2GPS000631-05
nct id: NCT01681914
lead sponsor: 
has dmc: No
Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this
      project seeks to assess the effectiveness of a subset of the new Mozambican clinical
      guidelines for the diagnosis, initial management, and follow-up ( >1 follow-up visit to
      determine response to initial and/or second-line therapy) of common signs and symptoms in
      HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in
      MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the
      new guidelines will be described; they will be compared to the previous standard of care for
      the problem(s) of interest, and the clinical importance of differences between guidelines
      designed for Mozambican non-physician clinicians and new guidelines (also issued in late
      2009) for Mozambican physicians will be described. The subset of guidelines to be addressed
      in the current phase of this 2-year project includes algorithms for diagnosis and management
      of acute fever, persistent fever, and anemia.
observational model: Cohort
time perspective: Prospective
measure: 1. What proportion of HIV-infected adult patients with common signs and symptoms can be assigned specific, potentially treatable diagnoses or syndromic classifications when evaluated in conformity with new Mozambican algorithms?
time frame: 6 months
measure: 2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)
time frame: 6 months
measure: 3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?
time frame: 6 months
measure: What proportion of HIV-infected adult patients with common signs and symptoms improve clinically when evaluated and managed in conformity with new Mozambican algorithms for técnicos de medicina?
time frame: 6 months
measure: What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?
time frame: 6 months
measure: For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.
time frame: 6 months
measure: What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?
time frame: 6 months
arm group label: Anemia
description: Ambulatory, HIV-infected adult patients with hemoglobin <10 g/dL will be evaluated and managed in accordance with Mozambique's new anemia guideline for non-physician clinicians. The basic steps recommended by the guideline are: screen for danger signs and stabilize or admit if indicated; perform rapid malaria antigen test (and/or peripheral blood smear) and treat if indicated; evaluate for adverse drug reactions and manage per Mozambican national guidelines; consider nutritional deficiencies and intestinal parasites; evaluate response to therapy at <=1 month.
arm group label: Fever or History of Fever
description: Ambulatory, HIV-infected adult patients with measured axillary temperature >=37.5 C or history of fever within the past 24 hours will be evaluated and managed in accordance with Mozambique's new fever guideline for non-physician clinicians. The basic steps of the fever guideline are: screen for danger signs and stabilize or admit if indicated; perform rapid malaria antigen test (and/or peripheral smear) and treat if indicated; treat any other cause of fever identified through history and physical examination; re-evaluate at next scheduled clinical visit (sooner if worse or if not improving within 48 hours of initiating treatment). Although blood cultures are seldom performed in Mozambican health centers, venipuncture specimens will also be cultured for bacterial pathogens at the first study visit.
arm group label: Anemia and Fever/History of Fever
description: Patients who meet eligibility criteria for both the anemia and fever arms will be evaluated and managed using both the new Mozambican anemia guideline and the new Mozambican fever guideline, as above.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paula E Brentlinger, MD, MPH
role: Principal Investigator
affiliation: Friends in Global Health
last name: Troy Moon, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
facility: 
facility: 
country: Mozambique
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Troy Moon
investigator title: Assistant Professor Department of Pediatric Infectious Diseases
mesh term: HIV Seropositivity