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Completed

NCT Number: NCT02540278

Evaluation of the Positive Prevention PLUS Program

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.

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Key information

Conditions

Pregnancy in Adolescence

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSUSB

San Bernardino, California, 92407, United States

About this study

A clustered randomized controlled trial (CRCT) was employed where participating high school sites were randomly assigned either to a treatment group that implemented the Positive Prevention PLUS program or a control group. Students completed a self-administered survey at baseline (prior to program implementation) and a 6 month follow-up survey (post program implementation). Eligible students in the sample included all male and female 9th-grade students from 21 high schools enrolled in mandatory 9th-grade health, science, or physical education classes, to which the district assigns students randomly. Of the 7,042 eligible students, 4,267 received parental consent and were enrolled in the study. Outcome variables include initiation of sexual activity, ever been pregnant, and birth control use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Positive Prevention PLUS

Behavioral

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.

Primary outcomes

  1. Ever had sex (Yes/No)

    Time frame: 6 months

    Ever had sex (Yes/No)

  2. Ever been pregnant (Yes/No)

    Time frame: 6 months

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

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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

California State University, San Bernardino

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Evaluation of the Positive Prevention PLUS Program Teen Pregnancy Prevention Program

Acronym: PP+

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2015
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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