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
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
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
NCT ID
NCT02612324
First Posted
November 12, 2015
Last Updated
November 2, 2020
Sponsor
University of Hawaii
Collaborators
IMPAQ International, LLC.
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
Learn more about this trial
An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program
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