Community-embedded Reproductive Health Care for Adolescents in Latin America. (CERCA)

December 4, 2014 updated by: University Ghent

Community-embedded Reproductive Health Care for Adolescents in Latin America (CERCA).

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

9625

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cochabamba, Bolivia
        • South Group
      • Cuenca, Ecuador
        • Universidad de Cuenca
      • Managua, Nicaragua
        • Centro de investigaciones y estudios de salud
      • Managua, Nicaragua
        • Instituto Centro Americano de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Nicaragua - adolescents aged 13-18 living in the 33 town districts of Managua with a population number that varies between 1400 and 4500 inhabitants and with more than 50 % poor people.

Bolivia and Ecuador: Students from conveniently selected secondary schools in Cochabamba (Bolivia) and Cuenca (Ecuador).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community-eùbedded reproductive health interventions
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.
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.
No Intervention: Community members without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported use of modern contraceptives at 18 months of interventions.
Time Frame: At 18 months of intervention
Self-reported exposure to intervention activities and registered participation at intervention activities.
At 18 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported ease to communicate about sexuality with parents, partner, friends.
Time Frame: At 18 months of intervention
Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
At 18 months of intervention
Self-reported access health services for sexual and reproductive health.
Time Frame: At 18 months of intervention
Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
At 18 months of intervention
Self-reported information seeking behaviour.
Time Frame: At 18 months of intervention
Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
At 18 months of intervention
Self-reported pregnancy.
Time Frame: At 18 months of intervention
Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
At 18 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marleen Temmerman, MD, PhD, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2011/380
  • FP7-health-241615

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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