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Multi-level Interventions for STD Prevention Among Adolescents

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ClinicalTrials.gov Identifier: NCT00146406
Recruitment Status : Terminated (IRB terminated due to no continuation request.)
First Posted : September 7, 2005
Last Update Posted : September 11, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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 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

Condition or disease Intervention/treatment
Chlamydia Behavioral: Project Connect

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36502 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Integrated Multi-level Interventions to Improve Adolescent Health Through the Prevention of STD, Including HIV, and Teen Pregnancy
Study Start Date : January 2005
Primary Completion Date : January 2012
Study Completion Date : January 2012
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Proportion of students who return to abstinence (measured yearly for 6 years)
  2. Proportion of sexually active students who have unprotected intercourse (measured yearly for 6 years)
  3. Proportion of sexually active students screened for chlamydia (measured yearly for 6 years)
  4. Prevelance of chlamydia from Baseline to Year 6
  5. Number of students who are sexually experienced (measured yearly for 6 years

Secondary Outcome Measures :
  1. Parental monitoring (measured yearly for 6 years)
  2. Parental communication (measured yearly for 6 years)
  3. Supervision (measured yearly for 6 years)
  4. Participation in after-school activities (measured yearly for 6 year)
  5. Use of reproductive health care services (measured yearly for 6 years)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Student at participating school

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146406


Locations
United States, California
Health Research Association
Los Angeles, California, United States, 90038
Sponsors and Collaborators
Centers for Disease Control and Prevention
Health Research Association
Investigators
Principal Investigator: Peter R Kerndt, M.D. Health Research Association
More Information

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00146406     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4347
U30/CCU922283-01
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Centers for Disease Control and Prevention:
Adolescent Health
Sexually Transmitted Disease
Sexual Behavior