Sexual and Reproductive Health Problems Clinical Trial
— CERCAOfficial title:
Community-embedded Reproductive Health Care for Adolescents in Latin America (CERCA).
| Verified date | December 2014 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9625 |
| Est. completion date | December 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 13 Years to 18 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Bolivia | South Group | Cochabamba | |
| Ecuador | Universidad de Cuenca | Cuenca | |
| Nicaragua | Centro de investigaciones y estudios de salud | Managua | |
| Nicaragua | Instituto Centro Americano de la Salud | Managua |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Lithuanian University of Health Sciences, VU University of Amsterdam |
Bolivia, Ecuador, Nicaragua,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self-reported use of modern contraceptives at 18 months of interventions. | Self-reported exposure to intervention activities and registered participation at intervention activities. | At 18 months of intervention | No |
| Secondary | Self-reported ease to communicate about sexuality with parents, partner, friends. | Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services. | At 18 months of intervention | No |
| Secondary | Self-reported access health services for sexual and reproductive health. | Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services. | At 18 months of intervention | No |
| Secondary | Self-reported information seeking behaviour. | Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services. | At 18 months of intervention | No |
| Secondary | Self-reported pregnancy. | Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services. | At 18 months of intervention | No |