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Multi-level Interventions for STD Prevention Among Adolescents

Primary Purpose

Chlamydia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Connect
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chlamydia focused on measuring Adolescent Health, Sexually Transmitted Disease, Sexual Behavior

Eligibility Criteria

11 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Student at participating school Exclusion Criteria: None

Sites / Locations

  • Health Research Association

Outcomes

Primary Outcome Measures

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 Outcome Measures

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)

Full Information

First Posted
September 2, 2005
Last Updated
September 10, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
Health Research Association
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1. Study Identification

Unique Protocol Identification Number
NCT00146406
Brief Title
Multi-level Interventions for STD Prevention Among Adolescents
Official Title
Integrated Multi-level Interventions to Improve Adolescent Health Through the Prevention of STD, Including HIV, and Teen Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
IRB terminated due to no continuation request.
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Health Research Association

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia
Keywords
Adolescent Health, Sexually Transmitted Disease, Sexual Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36502 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Project Connect
Primary Outcome Measure Information:
Title
Proportion of students who return to abstinence (measured yearly for 6 years)
Title
Proportion of sexually active students who have unprotected intercourse (measured yearly for 6 years)
Title
Proportion of sexually active students screened for chlamydia (measured yearly for 6 years)
Title
Prevelance of chlamydia from Baseline to Year 6
Title
Number of students who are sexually experienced (measured yearly for 6 years
Secondary Outcome Measure Information:
Title
Parental monitoring (measured yearly for 6 years)
Title
Parental communication (measured yearly for 6 years)
Title
Supervision (measured yearly for 6 years)
Title
Participation in after-school activities (measured yearly for 6 year)
Title
Use of reproductive health care services (measured yearly for 6 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Student at participating school Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R Kerndt, M.D.
Organizational Affiliation
Health Research Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Research Association
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States

12. IPD Sharing Statement

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Multi-level Interventions for STD Prevention Among Adolescents

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