Multi-level Interventions for STD Prevention Among Adolescents

Chlamydia Clinical Trial

Official title:

Integrated Multi-level Interventions to Improve Adolescent Health Through the Prevention of STD, Including HIV, and Teen Pregnancy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00146406
• Other study ID #: CDC-NCHSTP-4347
• Secondary ID: U30/CCU922283-01
• Status: Terminated
• Phase: N/A
• First received: September 2, 2005
• Last updated: September 10, 2012
• Start date: January 2005
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36502
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 20 Years

Eligibility

Inclusion Criteria:

• Student at participating school

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia

Intervention

Behavioral:
• Project Connect

Locations

Country	Name	City	State
United States	Health Research Association	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Health Research Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of students who return to abstinence (measured yearly for 6 years)
Primary	Proportion of sexually active students who have unprotected intercourse (measured yearly for 6 years)
Primary	Proportion of sexually active students screened for chlamydia (measured yearly for 6 years)
Primary	Prevelance of chlamydia from Baseline to Year 6
Primary	Number of students who are sexually experienced (measured yearly for 6 years
Secondary	Parental monitoring (measured yearly for 6 years)
Secondary	Parental communication (measured yearly for 6 years)
Secondary	Supervision (measured yearly for 6 years)
Secondary	Participation in after-school activities (measured yearly for 6 year)
Secondary	Use of reproductive health care services (measured yearly for 6 years)