ChlamydiaNCT00146406
Multi-level Interventions for STD Prevention Among Adolescents
A study testing Project Connect in people with Chlamydia, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of this research program is to develop, implement and evaluate integrated multi-level interventions to prevent STD, including HIV, and… Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Chlamydia
- What is being tested?
- Project Connect
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36,502 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2012
- 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 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Student at participating school
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Research Association
Los Angeles, California, 90038
About this study
Official title: Integrated Multi-level Interventions to Improve Adolescent Health Through the Prevention of STD, Including HIV, and Teen Pregnancy
Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of this research program is to develop, implement and evaluate integrated multi-level interventions to prevent STD, including HIV, and pregnancy among adolescents. The study includes 12 high schools and 19 of their feeder middle schools in the Los Angeles Unified School District and the surrounding communities. Interventions will be implemented among parents, health care providers, and in schools in an integrated fashion with the goal of improving social context factors related to health outcomes among adolescents. The evaluation phase will include in-school surveys with adolescents at all middle schools
Read the detailed description
In the current study we plan to implement interventions at four social context levels, that is, with parents, providers or in other medical institutions, schools and community venues, to improve communication between adolescents and adults, facilitate increased access and utilization of health care services, and appropriate supervision of adolescents outside of school hours. As such the goals of the specific level interventions are as follows.
Among parents: (1) to enhance communication and relationship satisfaction; (2) increase parents participation in the healthcare of their adolescents; and (3) to enhance appropriate monitoring and supervision of adolescents.
Among school-based health care providers: (1) to increase access to and utilization of services by adolescents; and (2) to increase STD screening of adolescents.
In middle schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (2) to address quality and fidelity of health education curriculum provision and teacher training; (3) to increase parental participation in school-related activities.
In high schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (3) to address quality and fidelity of health education curriculum provision and teacher training; (4) to increase parental participation in school-related activities; (5) to increase awareness and utilization of school-based condom availability programs.
In community venues: (1) increase adolescents utilization of community-based clinical services; (2) to increase adolescent utilization of non-clinic-based screening; and (3) to increase utilization of community-based supervised activities for youth.
Activities will address these goals with the ultimate purpose of reducing adolescent risk for STDs, including HIV, and teen pregnancy through (1) increased age at first intercourse, (2) return to abstinence among sexually active adolescents, (3) decreased rates of unprotected sex among adolescents, (4) and increased screening and treatment of STD-infected adolescents.
- Conditions
- Chlamydia
- Being tested
- Project Connect
- Keywords
- Adolescent Health, Sexually Transmitted Disease, Sexual Behavior
- Medical subject headings
- Chlamydia Infections, Sexually Transmitted Diseases, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ConnectBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of students who return to abstinence (measured yearly for 6 years)
Proportion of sexually active students who have unprotected intercourse (measured yearly for 6 years)
Proportion of sexually active students screened for chlamydia (measured yearly for 6 years)
Prevelance of chlamydia from Baseline to Year 6
Number of students who are sexually experienced (measured yearly for 6 years
Secondary outcomes (5)
Parental monitoring (measured yearly for 6 years)
Parental communication (measured yearly for 6 years)
Supervision (measured yearly for 6 years)
Participation in after-school activities (measured yearly for 6 year)
Use of reproductive health care services (measured yearly for 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: IRB terminated due to no continuation request.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 36,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Health Research Association
- Responsible party
- Sponsor
- Investigators
- Peter R Kerndt, M.D., Principal investigator, Health Research Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146406
- Sponsor's protocol ID
- CDC-NCHSTP-4347
- Other IDs
- U30/CCU922283-01
- Status last verified
- Sep 2012
- First submitted
- 2 Sep 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Multi-level Interventions to Improve Adolescent Health Through the Prevention of STD, Including HIV, and Teen Pregnancy
- ClinicalTrials.gov ID
- NCT00146406
- Acronym / sponsor ID
- CDC-NCHSTP-4347
- Conditions
- Chlamydia
- Keywords
- Adolescent Health, Sexually Transmitted Disease, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB terminated due to no continuation request.
- Enrolment
- 36,502 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Health Research Association
- Study start
- Jan 2005
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Sep 2005 (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.
Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of this research program is to develop, implement and evaluate integrated multi-level interventions to prevent STD, including HIV, and pregnancy among adolescents. The study includes 12 high schools and 19 of their feeder middle schools in the Los Angeles Unified School District and the surrounding communities. Interventions will be implemented among parents, health care providers, and in schools in an integrated fashion with the goal of improving social context factors related to health outcomes among adolescents. The evaluation phase will include in-school surveys with adolescents at all middle schools
Detailed description
In the current study we plan to implement interventions at four social context levels, that is, with parents, providers or in other medical institutions, schools and community venues, to improve communication between adolescents and adults, facilitate increased access and utilization of health care services, and appropriate supervision of adolescents outside of school hours. As such the goals of the specific level interventions are as follows.
Among parents: (1) to enhance communication and relationship satisfaction; (2) increase parents participation in the healthcare of their adolescents; and (3) to enhance appropriate monitoring and supervision of adolescents.
Among school-based health care providers: (1) to increase access to and utilization of services by adolescents; and (2) to increase STD screening of adolescents.
In middle schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (2) to address quality and fidelity of health education curriculum provision and teacher training; (3) to increase parental participation in school-related activities.
In high schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (3) to address quality and fidelity of health education curriculum provision and teacher training; (4) to increase parental participation in school-related activities; (5) to increase awareness and utilization of school-based condom availability programs.
In community venues: (1) increase adolescents utilization of community-based clinical services; (2) to increase adolescent utilization of non-clinic-based screening; and (3) to increase utilization of community-based supervised activities for youth.
Activities will address these goals with the ultimate purpose of reducing adolescent risk for STDs, including HIV, and teen pregnancy through (1) increased age at first intercourse, (2) return to abstinence among sexually active adolescents, (3) decreased rates of unprotected sex among adolescents, (4) and increased screening and treatment of STD-infected adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Student at participating school
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Project Connect | Behavioural | – |
Primary outcome
Proportion of students who return to abstinence (measured yearly for 6 years)
Proportion of sexually active students who have unprotected intercourse (measured yearly for 6 years)
Proportion of sexually active students screened for chlamydia (measured yearly for 6 years)
Prevelance of chlamydia from Baseline to Year 6
Number of students who are sexually experienced (measured yearly for 6 years
5 secondary outcomes
Parental monitoring (measured yearly for 6 years)
Parental communication (measured yearly for 6 years)
Supervision (measured yearly for 6 years)
Participation in after-school activities (measured yearly for 6 year)
Use of reproductive health care services (measured yearly for 6 years)
Results and safety
The study was stopped early (reason given: IRB terminated due to no continuation request.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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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.
Peter R Kerndt, M.D. principal investigator
Health Research Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Connect in people with Chlamydia, run by Centers for Disease Control and Prevention at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: IRB terminated due to no continuation request.). Results are not available in the source record.
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?
Proportion of students who return to abstinence (measured yearly for 6 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2012.