NCT02612324

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,783

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

November 12, 2015

Last Update Submit

November 2, 2020

Conditions

Keywords

adolescentsteen pregnancy preventionsexually transmitted infections preventionplace-based programshealth education

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 year

Other Outcomes (4)

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

    1 year

  • 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.

    1 year

  • 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.

    1 year

  • +1 more other outcomes

Study Arms (2)

Pono Choices

EXPERIMENTAL

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.

Behavioral: Pono Choices

Business as Usual

ACTIVE COMPARATOR

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

Behavioral: Business as Usual

Interventions

Pono ChoicesBEHAVIORAL

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.

Pono Choices

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

Business as Usual

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 24293268BACKGROUND
  • 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

    BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Sexually Transmitted DiseasesHealth Education

Interventions

Commerce

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

  • Kelly D Roberts, PhD

    University of Hawaii at Manoa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 23, 2015

Study Start

January 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 4, 2020

Record last verified: 2020-11