Clinical trial NCT01722084: Community-embedded Reproductive Health Care for Adolescents in Latin America.
Official title: Community-embedded Reproductive Health Care for Adolescents in Latin America (CERCA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual and Reproductive Health Problems
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Lithuanian University of Health Sciences
name: VU University of Amsterdam
First posted: 2012-11-06
Enrollment: 9625
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Self-reported use of modern contraceptives at 18 months of interventions.
timeFrame: At 18 months of intervention
Secondary outcomes:
measure: Self-reported ease to communicate about sexuality with parents, partner, friends.
timeFrame: At 18 months of intervention
measure: Self-reported access health services for sexual and reproductive health.
timeFrame: At 18 months of intervention
measure: Self-reported information seeking behaviour.
timeFrame: At 18 months of intervention
measure: Self-reported pregnancy.
timeFrame: At 18 months of intervention
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: South Group
city: Cuenca
country: Ecuador
facility: Universidad de Cuenca
city: Managua
country: Nicaragua
facility: Centro de investigaciones y estudios de salud
city: Managua
country: Nicaragua
facility: Instituto Centro Americano de la Salud
Study officials:
affiliation: University Ghent
name: Marleen Temmerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Decat P, Nelson E, De Meyer S, Jaruseviciene L, Orozco M, Segura Z, Gorter A, Vega B, Cordova K, Maes L, Temmerman M, Leye E, Degomme O. Community embedded reproductive health interventions for adolescents in Latin America: development and evaluation of a complex multi-centre intervention. BMC Public Health. 2013 Jan 14;13:31. doi: 10.1186/1471-2458-13-31.