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Completed

NCT Number: NCT02612324

An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program

The purpose of this study is to determine the impact Pono Choices has among youth for teen pregnancy and STI prevention measures such as: initiation of sexual activity; engagement in high risk sexual behaviors; knowledge of pregnancy and STI prevention; attitudes toward healthy sexual behaviors; skills in managing relationships and choices; and intentions about future sexual activity.

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Key information

Conditions

Teen Pregnancy Adherence Interventions Behavior Communicable Diseases Disease Attributes Genital Diseases Health Behavior Health Education Infections Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Sexually Transmitted Diseases Sexually Transmitted Infections Treatment Adherence and Compliance Urogenital Diseases

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study used a cluster randomized controlled design to evaluate the impact of Pono Choices. Thirty-six middle schools in Hawaii were randomly assigned to participate as either a treatment or control school. Treatment school teachers were trained to deliver Pono Choices. Control school teachers did not receive training and chose their own middle school sexual health education curricula.

Over 1,700 7th and 8th grade students in 34 Hawaii schools enrolled into the study. As part of the study, students were invited to participate in baseline and follow-up surveys. The student survey responses were used to determine the impact Pono Choices has on teen pregnancy and STI prevention measures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cluster level: Schools with grades 7 and 8 in Hawaii
  • Person level: Students with parent consent and who read and understand English

Exclusion criteria

  • Cluster level: Public middle schools which included grade 6
  • Person level: Students who did not provide written assent

Treatment and study plan

Pono Choices

Behavioral

Medically accurate teen pregnancy and STI prevention education delivered through a place-based framework integrating Hawaiian cultural activities that draw upon both historical and local references.

Business as usual

Behavioral

Teen pregnancy and STI prevention education left to the discretion of the school.

Primary outcomes

  1. Initiation of sexual activity assessed by the percent reporting on the questionnaire that they have had sexual intercourse.

    Time frame: 1 year

Secondary outcomes

  1. Engagement in high risk sexual behaviors assessed by the percent reporting on the questionnaire that they have engaged in sexual intercourse without a condom or other effective method of birth control in the past 3 months.

    Time frame: 1 year

Other outcomes

  1. Knowledge related to pregnancy & STI prevention assessed by the percent of pregnancy and STI prevention knowledge items on the questionnaire answered correctly.

    Time frame: 1 year

  2. Attitudes related to teen pregnancy & STI prevention behaviors assessed by the average rating of scale items on the questionnaire on the importance of healthy sexual behaviors.

    Time frame: 1 year

  3. Skills related to teen pregnancy & STI prevention assessed by the average rating of scale items on the questionnaire on difficulty of skills related to managing relationship and choices.

    Time frame: 1 year

  4. Intentions to have sex assessed by the scale response on the questionnaire on intention to have sex in the next 12 months.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • IMPAQ International, LLC.

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 23, 2015
Registry last updated
Nov 4, 2020

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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