Sexual and Reproductive Health ProblemsCERCANCT01722084
Community-embedded Reproductive Health Care for Adolescents in Latin America.
A study testing Theory of planned behaviour (TPB) and social cognitive theory (SCT). in people with Sexual and Reproductive Health Problems, run by University Ghent at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual and Reproductive Health Problems
- What is being tested?
- Theory of planned behaviour (TPB) and social cognitive theory (SCT).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,625 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Nicaragua2 sites
Centro de investigaciones y estudios de salud
Managua
Instituto Centro Americano de la Salud
Managua
About this study
Official title: 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).
Read more
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
- Being tested
- Theory of planned behaviour (TPB) and social cognitive theory (SCT).
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory of planned behaviour (TPB) and social cognitive theory (SCT).Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-eùbedded reproductive health interventions | Experimental | 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. Receives: Behavioral: Theory of planned behaviour (TPB) and social cognitive theory (SCT). |
| Community members without intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported use of modern contraceptives at 18 months of interventions.
Self-reported exposure to intervention activities and registered participation at intervention activities.
Measured: At 18 months of intervention
Secondary outcomes (4)
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.
Measured: At 18 months of intervention
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.
Measured: At 18 months of intervention
Self-reported information seeking behaviour.
Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
Measured: At 18 months of intervention
Self-reported pregnancy.
Self-reported exposure to intervention activities, registered participation at intervention activities and registered access of adolescents to health services.
Measured: At 18 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual and Reproductive Health ProblemsStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,625 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Lithuanian University of Health Sciences, VU University of Amsterdam
- Responsible party
- Sponsor
- Investigators
- Marleen Temmerman, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722084
- Sponsor's protocol ID
- 2011/380
- Other IDs
- FP7-health-241615
- Acronym
- CERCA
- Status last verified
- Dec 2014
- First submitted
- 29 Oct 2012
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23311647
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-embedded Reproductive Health Care for Adolescents in Latin America (CERCA).
- ClinicalTrials.gov ID
- NCT01722084
- Acronym / sponsor ID
- CERCA / 2011/380
- Conditions
- Sexual and Reproductive Health Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,625 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Lithuanian University of Health Sciences, VU University of Amsterdam
- Study start
- Jul 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-eùbedded reproductive health interventions | Experimental | Behavioral: Theory of planned behaviour (TPB) and social cognitive theory (SCT).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. |
| Community members without intervention | No intervention | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Community-eùbedded reproductive health interventions |
Primary outcome
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.
4 secondary outcomes
Self-reported ease to communicate about sexuality with parents, partner, friends.
Time frame: At 18 months of intervention
Self-reported access health services for sexual and reproductive health.
Time frame: At 18 months of intervention
Self-reported information seeking behaviour.
Time frame: At 18 months of intervention
Self-reported pregnancy.
Time frame: At 18 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 23311647Decat 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marleen Temmerman, MD, PhD principal investigator
University Ghent
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory of planned behaviour (TPB) and social cognitive theory (SCT). in people with Sexual and Reproductive Health Problems, run by University Ghent at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Nicaragua, Bolivia, Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported use of modern contraceptives at 18 months of interventions. (time frame: At 18 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.