<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/NCT01722084</url>
  </required_header>
  <id_info>
    <org_study_id>2011/380</org_study_id>
    <secondary_id>FP7-health-241615</secondary_id>
    <nct_id>NCT01722084</nct_id>
  </id_info>
  <brief_title>Community-embedded Reproductive Health Care for Adolescents in Latin America.</brief_title>
  <acronym>CERCA</acronym>
  <official_title>Community-embedded Reproductive Health Care for Adolescents in Latin America (CERCA).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lithuanian University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VU University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe&#xD;
      abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on&#xD;
      unidirectional interventions aiming at a single determinant of adolescents´ sexual and&#xD;
      reproductive health. However, evidence exists that a complex health problem should be&#xD;
      addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to&#xD;
      develop a comprehensive approach to promote adolescents' sexual health.&#xD;
&#xD;
      The CERCA study will conduct an implementation based on the hypothesis that a comprehensive&#xD;
      strategy of community-embedded interventions helps to improve the sexual health of&#xD;
      adolescents. We will test this hypothesis and describe the development, implementation and&#xD;
      testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca&#xD;
      (Ecuador) and Managua (Nicaragua).&#xD;
&#xD;
      The research methodology has been designed based on the methodological frameworks of action&#xD;
      research, community based participatory research and intervention mapping.&#xD;
&#xD;
      The interventions are complex addressing different target groups (adolescents, parents,&#xD;
      authorities and health providers) and focussing on various behaviours that are related to&#xD;
      communication about sexuality, information seeking, access to health care and safe sexual&#xD;
      intercourse.&#xD;
&#xD;
      For the evaluation of effectiveness a randomised and non-randomised controlled study was&#xD;
      developed for respectively Managua and the two other cities. Furthermore a process evaluation&#xD;
      is conducted.&#xD;
&#xD;
      This research will result in a framework that will contribute to the planning of&#xD;
      interventions that are effective and responsive to adolescents' sexual health needs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported use of modern contraceptives at 18 months of interventions.</measure>
    <time_frame>At 18 months of intervention</time_frame>
    <description>Self-reported exposure to intervention activities and registered participation at intervention activities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported ease to communicate about sexuality with parents, partner, friends.</measure>
    <time_frame>At 18 months of intervention</time_frame>
    <description>Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported access health services for sexual and reproductive health.</measure>
    <time_frame>At 18 months of intervention</time_frame>
    <description>Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported information seeking behaviour.</measure>
    <time_frame>At 18 months of intervention</time_frame>
    <description>Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported pregnancy.</measure>
    <time_frame>At 18 months of intervention</time_frame>
    <description>Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9625</enrollment>
  <condition>Sexual and Reproductive Health Problems</condition>
  <arm_group>
    <arm_group_label>Community-eùbedded reproductive health interventions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Members of communities that belonged to the intervention arm were exposed to complex interventions addressing different target groups (adolescents, parents, authorities and health providers) and focusing on various behaviours that were related to communication about sexuality, information seeking, access to health care and safe sexual intercourse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community members without intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Theory of planned behaviour (TPB) and social cognitive theory (SCT).</intervention_name>
    <description>TPB is appropriate to influence adolescents' behaviour related to the use of contraceptive methods and their health/information seeking behaviour. The SCT helped to find out strategies to improve communication about sexuality, to promote openness towards adolescents' sexuality among parents, community members and health providers and for health providers to adopt a more adolescent friendly attitude.The development of the strategies in the different countries is a dynamic process that is continuously being adapted. The target groups were &quot;driving&quot; the process of identifying, selecting and implementing interventions. Therefore, local institutions were involved in the intervention. Attention was paid to ensure that the interventions were in line with the existing local structures/policies and reinforce the local health system.Primary health care services had a key role in the interventions. Gender was a transversal topic throughout the intervention process.</description>
    <arm_group_label>Community-eùbedded reproductive health interventions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Nicaragua - adolescents aged 13-18 living in the 33 town districts of Managua with a&#xD;
        population number that varies between 1400 and 4500 inhabitants and with more than 50 %&#xD;
        poor people.&#xD;
&#xD;
        Bolivia and Ecuador: Students from conveniently selected secondary schools in Cochabamba&#xD;
        (Bolivia) and Cuenca (Ecuador).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marleen Temmerman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Group</name>
      <address>
        <city>Cochabamba</city>
        <country>Bolivia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad de Cuenca</name>
      <address>
        <city>Cuenca</city>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de investigaciones y estudios de salud</name>
      <address>
        <city>Managua</city>
        <country>Nicaragua</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Centro Americano de la Salud</name>
      <address>
        <city>Managua</city>
        <country>Nicaragua</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bolivia</country>
    <country>Ecuador</country>
    <country>Nicaragua</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>December 4, 2014</last_update_submitted>
  <last_update_submitted_qc>December 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01722084
org study id: 2011/380
secondary id: FP7-health-241615
nct id: NCT01722084
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe
      abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on
      unidirectional interventions aiming at a single determinant of adolescents´ sexual and
      reproductive health. However, evidence exists that a complex health problem should be
      addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to
      develop a comprehensive approach to promote adolescents' sexual health.

      The CERCA study will conduct an implementation based on the hypothesis that a comprehensive
      strategy of community-embedded interventions helps to improve the sexual health of
      adolescents. We will test this hypothesis and describe the development, implementation and
      testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca
      (Ecuador) and Managua (Nicaragua).

      The research methodology has been designed based on the methodological frameworks of action
      research, community based participatory research and intervention mapping.

      The interventions are complex addressing different target groups (adolescents, parents,
      authorities and health providers) and focussing on various behaviours that are related to
      communication about sexuality, information seeking, access to health care and safe sexual
      intercourse.

      For the evaluation of effectiveness a randomised and non-randomised controlled study was
      developed for respectively Managua and the two other cities. Furthermore a process evaluation
      is conducted.

      This research will result in a framework that will contribute to the planning of
      interventions that are effective and responsive to adolescents' sexual health needs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Self-reported use of modern contraceptives at 18 months of interventions.
time frame: At 18 months of intervention
description: Self-reported exposure to intervention activities and registered participation at intervention activities.
measure: Self-reported ease to communicate about sexuality with parents, partner, friends.
time frame: At 18 months of intervention
description: Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
measure: Self-reported access health services for sexual and reproductive health.
time frame: At 18 months of intervention
description: Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
measure: Self-reported information seeking behaviour.
time frame: At 18 months of intervention
description: Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
measure: Self-reported pregnancy.
time frame: At 18 months of intervention
description: Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
arm group label: Community-eùbedded reproductive health interventions
arm group type: Experimental
description: Members of communities that belonged to the intervention arm were exposed to complex interventions addressing different target groups (adolescents, parents, authorities and health providers) and focusing on various behaviours that were related to communication about sexuality, information seeking, access to health care and safe sexual intercourse.
arm group label: Community members without intervention
arm group type: No Intervention
intervention type: Behavioral
intervention name: Theory of planned behaviour (TPB) and social cognitive theory (SCT).
description: TPB is appropriate to influence adolescents' behaviour related to the use of contraceptive methods and their health/information seeking behaviour. The SCT helped to find out strategies to improve communication about sexuality, to promote openness towards adolescents' sexuality among parents, community members and health providers and for health providers to adopt a more adolescent friendly attitude.The development of the strategies in the different countries is a dynamic process that is continuously being adapted. The target groups were "driving" the process of identifying, selecting and implementing interventions. Therefore, local institutions were involved in the intervention. Attention was paid to ensure that the interventions were in line with the existing local structures/policies and reinforce the local health system.Primary health care services had a key role in the interventions. Gender was a transversal topic throughout the intervention process.
arm group label: Community-eùbedded reproductive health interventions
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marleen Temmerman, MD, PhD
role: Principal Investigator
affiliation: University Ghent
facility: 
facility: 
facility: 
facility: 
country: Bolivia
country: Ecuador
country: Nicaragua
responsible party type: Sponsor