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

NCT ID: NCT01722084

Last Updated: 2014-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9625 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Sexual and Reproductive Health Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Theory of planned behaviour (TPB) and social cognitive theory (SCT).

Intervention Type: BEHAVIORAL

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.

Community members without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Theory of planned behaviour (TPB) and social cognitive theory (SCT).

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: collaborator

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marleen Temmerman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

South Group

Cochabamba, , Bolivia

Universidad de Cuenca

Cuenca, , Ecuador

Centro de investigaciones y estudios de salud

Managua, , Nicaragua

Instituto Centro Americano de la Salud

Managua, , Nicaragua

Countries

Bolivia; Ecuador; Nicaragua

References

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.

Reference Type: DERIVED

PMID: 23311647 (View on PubMed)

Other Identifiers

FP7-health-241615

Identifier Type: -

Identifier Source: secondary_id

2011/380

Identifier Type: -

Identifier Source: org_study_id