NCT00146406

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36,502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

7 years

First QC Date

September 2, 2005

Last Update Submit

September 10, 2012

Conditions

Keywords

Adolescent HealthSexually Transmitted DiseaseSexual Behavior

Outcome Measures

Primary Outcomes (5)

  • 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)

Interventions

Project ConnectBEHAVIORAL

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Student at participating school

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Research Association

Los Angeles, California, 90038, United States

Location

MeSH Terms

Conditions

Chlamydia InfectionsSexually Transmitted DiseasesSexual Behavior

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialCommunicable DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Peter R Kerndt, M.D.

    Health Research Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations