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Completed

NCT Number: NCT01722084

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

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.

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Key information

Conditions

Sexual and Reproductive Health Problems Behavior Coitus Sexual Behavior

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Group, Cochabamba, Bolivia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Lithuanian University of Health Sciences
  • VU University of Amsterdam

Registry information

Official study title

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

Acronym: CERCA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 6, 2012
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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