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

Primary Purpose

Teen Pregnancy, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pono Choices
Business as Usual
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Teen Pregnancy focused on measuring adolescents, teen pregnancy prevention, sexually transmitted infections prevention, place-based programs, health education

Eligibility Criteria

10 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pono Choices

    Business as Usual

    Arm Description

    Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program for Middle School Youth in Hawaii. The program includes 9.5 hours of scripted lessons or modules.

    Middle school sexual health content or programs chosen by control group schools.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 12, 2015
    Last Updated
    November 2, 2020
    Sponsor
    University of Hawaii
    Collaborators
    IMPAQ International, LLC.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02612324
    Brief Title
    An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Hawaii
    Collaborators
    IMPAQ International, LLC.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Teen Pregnancy, Sexually Transmitted Infections
    Keywords
    adolescents, teen pregnancy prevention, sexually transmitted infections prevention, place-based programs, health education

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1783 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pono Choices
    Arm Type
    Experimental
    Arm Description
    Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program for Middle School Youth in Hawaii. The program includes 9.5 hours of scripted lessons or modules.
    Arm Title
    Business as Usual
    Arm Type
    Active Comparator
    Arm Description
    Middle school sexual health content or programs chosen by control group schools.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pono Choices
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Business as Usual
    Intervention Description
    Teen pregnancy and STI prevention education left to the discretion of the school.
    Primary Outcome Measure Information:
    Title
    Initiation of sexual activity assessed by the percent reporting on the questionnaire that they have had sexual intercourse.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    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 Pre-specified Outcome Measures:
    Title
    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
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kelly D Roberts, PhD
    Organizational Affiliation
    University of Hawaii at Manoa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24293268
    Citation
    Manaseri H, Uehara D, Roberts K. Making Pono Choices: a collaborative approach to developing a culturally responsive teen pregnancy and sexually transmitted infections prevention curriculum in Hawai'i. Matern Child Health J. 2014 Dec;18(10):2332-40. doi: 10.1007/s10995-013-1395-6.
    Results Reference
    background
    Citation
    Manaseri, H, Roberts, K, Stofocik, K, Manuel, N, Uehara, D (2014). Culture as a Protective Factor: The Use of Storytelling in a Teen Pregnancy and STI Prevention Curriculum. Health Care Current Reviews, 2(3). doi:dx.doi.org/10.4172/hccr.1000127
    Results Reference
    background
    PubMed Identifier
    27689477
    Citation
    Abe Y, Barker LT, Chan V, Eucogco J. Culturally Responsive Adolescent Pregnancy and Sexually Transmitted Infection Prevention Program for Middle School Students in Hawai'i. Am J Public Health. 2016 Sep;106(S1):S110-S116. doi: 10.2105/AJPH.2016.303395.
    Results Reference
    result
    PubMed Identifier
    30740698
    Citation
    Manaseri H, Roberts KD, Barker LT, Tom T. Pono Choices: Lessons for School Leaders From the Evaluation of a Teen Pregnancy Prevention Program. J Sch Health. 2019 Apr;89(4):246-256. doi: 10.1111/josh.12733. Epub 2019 Feb 11.
    Results Reference
    result
    Links:
    URL
    http://www.cds.hawaii.edu/ponochoices/facilitators/curriculum-development/
    Description
    Pono Choices Project website (curriculum development page)
    URL
    http://www.hhs.gov/ash/oah/oah-initiatives/tpp_program/
    Description
    (federal) Office of Adolescent Health website
    URL
    http://www.amchp.org/programsandtopics/BestPractices/InnovationStation/ISDocs/Implementation%20Handout_Pono%20Choices%202019.pdf
    Description
    AMCHP Best Practice Award Implementation Guide for Pono Choices

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

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