NCT02540278

Brief Summary

This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

August 25, 2015

Last Update Submit

September 1, 2015

Conditions

Pregnancy in Adolescence

Outcome Measures

Primary Outcomes (3)

  • Ever had sex (Yes/No)

    Ever had sex (Yes/No)

    6 months

  • Ever been pregnant (Yes/No)

    Ever Been Pregnant (or gotten someone pregnant) (Yes/No)

    6 months

  • Sex without using birth control in prior 3 months (Yes/No)

    Ever had sex without using birth control in prior 3 months (Yes/No)

    6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Received the 11 lesson Positive Prevention Curriculum

Behavioral: Positive Prevention PLUS

Control

NO INTERVENTION

Did not receive any sex-related instruction

Interventions

Positive Prevention PLUSBEHAVIORAL

PP+ has elven 45 minute lessons: (1) Getting Started, (2) Life Planning, (3) Healthy Relationships, (4) Relationship Violence, (5) Family Planning and Contraceptives, (6) Myths and Stereotypes, (7) HIV Disease and AIDS, (8) Recognizing and Reducing Risk, (9) Peer and Media Pressures, (10) Human Immunodeficiency Virus (HIV)/Sexually Transmitted Disease (STD) Testing and Community Resources, and (11) Steps to Success.

Treatment

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must have parental consent and be in the eligible school sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSUSB

San Bernardino, California, 92407, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 3, 2015

Study Start

August 1, 2013

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

US(1)