<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/NCT03024762</url>
  </required_header>
  <id_info>
    <org_study_id>R4D0007/2015</org_study_id>
    <nct_id>NCT03024762</nct_id>
  </id_info>
  <brief_title>Active Search for Pediatric HIV/AIDS (ASPA)</brief_title>
  <acronym>ASPA</acronym>
  <official_title>Active Search for Pediatric HIV/AIDS (ASPA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research for Development International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Else Kröner Fresenius Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Research for Development International</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability,&#xD;
      feasibility and effectiveness of the targeted provider-initiated-testing and counseling&#xD;
      (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC)&#xD;
      among children and adolescents in Cameroon. The new knowledge generated will inform&#xD;
      programming of more suitable strategies to identify HIV-infected children and adolescents and&#xD;
      this will contribute to reducing the current global gap in HIV treatment among this&#xD;
      subpopulation group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Globally in 2014, the antiretroviral therapy (ART) coverage rate amongst&#xD;
      children was 32% against 41% in adults, and in Cameroon this gap was even wider (10.4% % vs&#xD;
      28%). Identifying and linking children to care are key barriers to effective expansion of&#xD;
      pediatric ART in resources-limited settings. To identify HIV-infected children and enroll&#xD;
      positive cases in care, the World Health Organization (WHO) recommended in 2007, the&#xD;
      provider-initiated-testing and counseling (PITC) strategy. The blanket PITC (bPITC), whereby&#xD;
      all children consulting in the health facility have to be screened for HIV requires a lot of&#xD;
      resources in terms of HIV testing kits and supplies in addition to the increased workload on&#xD;
      the already overburden health personnel in resource-limited settings. Conversely, the&#xD;
      targeted PITC approach (tPITC) where children born to HIV-infected parents are offered HIV&#xD;
      testing and counseling seems more feasible and effective. The primary objective of this study&#xD;
      is to assess the effectiveness of tPITC in comparison with bPITC in case detection of&#xD;
      HIV-infected children and adolescents. The secondary objective is to assess the acceptability&#xD;
      and feasibility of tPITC in comparison with bPTIC among children and adolescents in Cameroon.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Design: The investigator will conduct in 3 health facilities a non-randomized controlled&#xD;
      pragmatic trial comparing the effectiveness of the targeted (intervention arm) against the&#xD;
      blanket PITC (control arm) in case finding and linkage of HIV-infected children and&#xD;
      adolescents in HIV treatment.&#xD;
&#xD;
      Study population: For the intervention arm, the study population will be children and&#xD;
      adolescents between 6 weeks to 19 years born to HIV-infected parents and the control arm will&#xD;
      be children of the same age group seeking care in the hospital irrespective of the motive of&#xD;
      consultations.&#xD;
&#xD;
      Procedure: The study will be implemented in the Limbe Regional Hospital (South West Region),&#xD;
      the Abong-Mbang District Hospital (East Region) and the Ndop District Hospital (North West&#xD;
      Region) in Cameroon for a period of 36 months. Prior to the conduct of the study, health&#xD;
      facility staff will be trained in PITC implementation. Testing kits and supplies will be made&#xD;
      available to the site. Enrolment in the 2 arms will be done simultaneously till completion of&#xD;
      the sample size. The HIV testing and ART eligibility assessment will be done following the&#xD;
      national guidelines.&#xD;
&#xD;
      Sample size calculation: Based on the results of the pilot of this targeted PITC, we believe&#xD;
      that with its implementation, the yield of newly diagnosed HIV cases amongst children should&#xD;
      at least equal the double of the yield the blanket PITC (control arm) in same health&#xD;
      facility. Therefore, the investigators have calculated the sample size to detect the minimum&#xD;
      effect in the intervention group equal to at least the double of the yield in the control&#xD;
      arm. Computing the formula for sample size calculation of 2 independent samples, we obtained&#xD;
      a sample size of 435 children per arm. Hence a total sample size of 870 children.&#xD;
&#xD;
      Data collection, management and analysis: Socio-demographic data for children and parents,&#xD;
      HIV status and ART eligibility, linkage to care and HIV treatment outcome will be collected&#xD;
      using standardized pre-tested questionnaires. A database will be developed on Microsoft&#xD;
      Access for data entry. Data entry will be done progressively till the study sample size is&#xD;
      attained. Data analysis will be done using SPSS software and findings will be reported using&#xD;
      both descriptive and analytical statistics.&#xD;
&#xD;
      Ethical considerations: Parents' informed consent and children' assent will be required for&#xD;
      enrollment into the study. The study will obtain an ethical clearance prior to&#xD;
      implementation.&#xD;
&#xD;
      Outcome: This study will assess the effectiveness of targeted PITC in case identification and&#xD;
      linkage of HIV-infected children to care/treatment. This new knowledge could be used to&#xD;
      reduce the current global gap in pediatric and adolescent HIV treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The intervention assessed is the targeted Provider-Initiated Testing and Counselling (tPITC) whereby HIV positive parents receiving HIV services in the hospital are invited to have their children of unknown HIV status tested for HIV. The control arm is the blanket Provider-Initiated Testing and Counselling (bPITC) whereby all children consulting in the hospital (and with unknown HIV status) are invited to test for HIV and this irrespective of the presenting complaint. The study is assessing in the same hospital the effectiveness of tPITC vs bPITC.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yield</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of newly identified HIV cases amongst all children and adolescents eligible for HIV testing 2. Prevalence: proportion of HIV cases amongst children tested</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence</measure>
    <time_frame>6 months</time_frame>
    <description>Prevalence: proportion of HIV cases amongst children and adolescents tested for HIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linkage</measure>
    <time_frame>6 months</time_frame>
    <description>Linkage in care: proportion of pediatric HIV cases linked to care (CD4 testing and/or enrolment on ART)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined effect (tPITC+bPITC)</measure>
    <time_frame>6 months</time_frame>
    <description>Combined effect of tPITC and bPITC: Number of children tested positive and initiated on ART in the hospital during the study as compared to historical data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>6 months</time_frame>
    <description>HIV testing acceptance rate: proportion of parents who accepted to have their children tested for HIV. The acceptability assesses the attitude of parents/caregivers to opt in for HIV testing of their children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>feasibility</measure>
    <time_frame>6 months</time_frame>
    <description>HIV testing uptake: proportion of children tested amongst all eligible identified through parents in HIV care (for the targeted arm) or amongst all eligible children who visited the hospital (control arm) during the enrolment period. The feasibility outcome variable assesses the capacity of the health facility to routinely test all eligible children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>24 months</time_frame>
    <description>Retention in care: proportion of cases still in care 12 and 24 months after enrolment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">870</enrollment>
  <condition>Pediatric HIV Infection</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years; consulting in the hospital for any motive. These children will be recruited for HIV testing at the outpatient department (OPD) and this through their accompany parents/guardians. Care providers will be advised to propose HIV testing systematically to all children and adolescents showing up at the OPD irrespective of the chief complaint.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>targeted Provider-Initiated-Testing and Counseling (tPITC)</intervention_name>
    <description>The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected parents: Parents diagnosed with HIV infection or receiving HIV services&#xD;
             in the hospital and consenting to participate will be eligible for enrollment in the&#xD;
             study.&#xD;
&#xD;
          -  Parents/guardians seeking care for their children in the hospital: Parents/guardians&#xD;
             presenting at the hospital with sick children will be enrolled in the study&#xD;
             irrespective of the motive of consultations for their children.&#xD;
&#xD;
          -  Children of HIV infected parents: children of HIV infected parents aged between 6&#xD;
             weeks to 19 years old will be eligible for enrollment in the study. Parents/guardians&#xD;
             consent will be required as well as assent of older kids.&#xD;
&#xD;
          -  Children consulting in the hospital: Children aged 6 weeks to 19 years old consulting&#xD;
             in the hospital for any reason will be eligible to participate in the study.&#xD;
             Parents/guardians consent will be required as well as assent of older kids.&#xD;
&#xD;
          -  HIV infected children: children (6weeks&lt;years&lt;19 years old) enrolled in HIV care in&#xD;
             the hospital at least 2 years before the beginning of the project and after this&#xD;
             beginning will be enrolled into the study to assess retention into care and factors&#xD;
             associated with loss to follow up.&#xD;
&#xD;
          -  Health personnel: Health personnel involved in children's consultations and consenting&#xD;
             to participate will be enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate: health personnel, parents/guardians, children not willing to&#xD;
             participate will be excluded from the study&#xD;
&#xD;
          -  HIV Status: Children with known HIV positive status will be excluded for HIV testing&#xD;
&#xD;
          -  Age: Children below the age of 6 weeks or above 19 years will be excluded from the&#xD;
             study&#xD;
&#xD;
          -  Health conditions: parents who are critically ill or mentally unstable will be&#xD;
             excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Habakkuk Yumo, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research for Development International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abong-Mbang District Hospital</name>
      <address>
        <city>Abong Mbang</city>
        <state>East</state>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ndop District Hospital</name>
      <address>
        <city>Ndop</city>
        <state>North West</state>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limbe Regional Hospital</name>
      <address>
        <city>Limbe</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cameroon</country>
  </location_countries>
  <link>
    <url>http://www.r4dinternational.org/</url>
    <description>Research for Development International</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 22, 2017</last_update_submitted>
  <last_update_submitted_qc>January 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Research for Development International</investigator_affiliation>
    <investigator_full_name>Dr Yumo, Habakkuk Azinyui</investigator_full_name>
    <investigator_title>Dr Yumo, Habakkuk Azinyui, MD, MPH</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data can be made available to other researchers through an application addressed to the sponsor (Research for Development International) and this via the Principal Investigator (Dr Yumo Habakkuk).</ipd_description>
  </patient_data>
  <!-- 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/NCT03024762
org study id: R4D0007/2015
nct id: NCT03024762
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability,
      feasibility and effectiveness of the targeted provider-initiated-testing and counseling
      (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC)
      among children and adolescents in Cameroon. The new knowledge generated will inform
      programming of more suitable strategies to identify HIV-infected children and adolescents and
      this will contribute to reducing the current global gap in HIV treatment among this
      subpopulation group.
Introduction: Globally in 2014, the antiretroviral therapy (ART) coverage rate amongst
      children was 32% against 41% in adults, and in Cameroon this gap was even wider (10.4% % vs
      28%). Identifying and linking children to care are key barriers to effective expansion of
      pediatric ART in resources-limited settings. To identify HIV-infected children and enroll
      positive cases in care, the World Health Organization (WHO) recommended in 2007, the
      provider-initiated-testing and counseling (PITC) strategy. The blanket PITC (bPITC), whereby
      all children consulting in the health facility have to be screened for HIV requires a lot of
      resources in terms of HIV testing kits and supplies in addition to the increased workload on
      the already overburden health personnel in resource-limited settings. Conversely, the
      targeted PITC approach (tPITC) where children born to HIV-infected parents are offered HIV
      testing and counseling seems more feasible and effective. The primary objective of this study
      is to assess the effectiveness of tPITC in comparison with bPITC in case detection of
      HIV-infected children and adolescents. The secondary objective is to assess the acceptability
      and feasibility of tPITC in comparison with bPTIC among children and adolescents in Cameroon.

      Methods:

      Design: The investigator will conduct in 3 health facilities a non-randomized controlled
      pragmatic trial comparing the effectiveness of the targeted (intervention arm) against the
      blanket PITC (control arm) in case finding and linkage of HIV-infected children and
      adolescents in HIV treatment.

      Study population: For the intervention arm, the study population will be children and
      adolescents between 6 weeks to 19 years born to HIV-infected parents and the control arm will
      be children of the same age group seeking care in the hospital irrespective of the motive of
      consultations.

      Procedure: The study will be implemented in the Limbe Regional Hospital (South West Region),
      the Abong-Mbang District Hospital (East Region) and the Ndop District Hospital (North West
      Region) in Cameroon for a period of 36 months. Prior to the conduct of the study, health
      facility staff will be trained in PITC implementation. Testing kits and supplies will be made
      available to the site. Enrolment in the 2 arms will be done simultaneously till completion of
      the sample size. The HIV testing and ART eligibility assessment will be done following the
      national guidelines.

      Sample size calculation: Based on the results of the pilot of this targeted PITC, we believe
      that with its implementation, the yield of newly diagnosed HIV cases amongst children should
      at least equal the double of the yield the blanket PITC (control arm) in same health
      facility. Therefore, the investigators have calculated the sample size to detect the minimum
      effect in the intervention group equal to at least the double of the yield in the control
      arm. Computing the formula for sample size calculation of 2 independent samples, we obtained
      a sample size of 435 children per arm. Hence a total sample size of 870 children.

      Data collection, management and analysis: Socio-demographic data for children and parents,
      HIV status and ART eligibility, linkage to care and HIV treatment outcome will be collected
      using standardized pre-tested questionnaires. A database will be developed on Microsoft
      Access for data entry. Data entry will be done progressively till the study sample size is
      attained. Data analysis will be done using SPSS software and findings will be reported using
      both descriptive and analytical statistics.

      Ethical considerations: Parents' informed consent and children' assent will be required for
      enrollment into the study. The study will obtain an ethical clearance prior to
      implementation.

      Outcome: This study will assess the effectiveness of targeted PITC in case identification and
      linkage of HIV-infected children to care/treatment. This new knowledge could be used to
      reduce the current global gap in pediatric and adolescent HIV treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The intervention assessed is the targeted Provider-Initiated Testing and Counselling (tPITC) whereby HIV positive parents receiving HIV services in the hospital are invited to have their children of unknown HIV status tested for HIV. The control arm is the blanket Provider-Initiated Testing and Counselling (bPITC) whereby all children consulting in the hospital (and with unknown HIV status) are invited to test for HIV and this irrespective of the presenting complaint. The study is assessing in the same hospital the effectiveness of tPITC vs bPITC.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Yield
time frame: 6 months
description: Proportion of newly identified HIV cases amongst all children and adolescents eligible for HIV testing 2. Prevalence: proportion of HIV cases amongst children tested
measure: Prevalence
time frame: 6 months
description: Prevalence: proportion of HIV cases amongst children and adolescents tested for HIV
measure: Linkage
time frame: 6 months
description: Linkage in care: proportion of pediatric HIV cases linked to care (CD4 testing and/or enrolment on ART)
measure: Combined effect (tPITC+bPITC)
time frame: 6 months
description: Combined effect of tPITC and bPITC: Number of children tested positive and initiated on ART in the hospital during the study as compared to historical data.
measure: Acceptability
time frame: 6 months
description: HIV testing acceptance rate: proportion of parents who accepted to have their children tested for HIV. The acceptability assesses the attitude of parents/caregivers to opt in for HIV testing of their children.
measure: feasibility
time frame: 6 months
description: HIV testing uptake: proportion of children tested amongst all eligible identified through parents in HIV care (for the targeted arm) or amongst all eligible children who visited the hospital (control arm) during the enrolment period. The feasibility outcome variable assesses the capacity of the health facility to routinely test all eligible children
measure: Retention
time frame: 24 months
description: Retention in care: proportion of cases still in care 12 and 24 months after enrolment
arm group label: Intervention arm
arm group type: Experimental
description: The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.
arm group label: Control arm
arm group type: No Intervention
description: The control arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years; consulting in the hospital for any motive. These children will be recruited for HIV testing at the outpatient department (OPD) and this through their accompany parents/guardians. Care providers will be advised to propose HIV testing systematically to all children and adolescents showing up at the OPD irrespective of the chief complaint.
intervention type: Procedure
intervention name: targeted Provider-Initiated-Testing and Counseling (tPITC)
description: The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Habakkuk Yumo, MD, MPH
role: Principal Investigator
affiliation: Research for Development International
facility: 
facility: 
facility: 
country: Cameroon
url: http://www.r4dinternational.org/
description: Research for Development International
responsible party type: Principal Investigator
investigator affiliation: Research for Development International
investigator full name: Dr Yumo, Habakkuk Azinyui
investigator title: Dr Yumo, Habakkuk Azinyui, MD, MPH
mesh term: HIV Infections
sharing ipd: Yes
ipd description: Data can be made available to other researchers through an application addressed to the sponsor (Research for Development International) and this via the Principal Investigator (Dr Yumo Habakkuk).