- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722084
Community-embedded Reproductive Health Care for Adolescents in Latin America. (CERCA)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Marleen Temmerman, MD, PhD, University Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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