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

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ClinicalTrials.gov Identifier: NCT02612324
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
IMPAQ International, LLC.
Information provided by (Responsible Party):
University of Hawaii

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.

Condition or disease Intervention/treatment Phase
Teen Pregnancy Sexually Transmitted Infections Behavioral: Pono Choices Behavioral: Business as Usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1783 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Pono Choices
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
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.

Active Comparator: Business as Usual
Middle school sexual health content or programs chosen by control group schools.
Behavioral: Business as Usual
Teen pregnancy and STI prevention education left to the discretion of the school.




Primary Outcome Measures :
  1. Initiation of sexual activity assessed by the percent reporting on the questionnaire that they have had sexual intercourse. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612324


Sponsors and Collaborators
University of Hawaii
IMPAQ International, LLC.
Investigators
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Principal Investigator: Kelly D Roberts, PhD University of Hawaii at Manoa

Additional Information:
Publications of Results:
Other Publications:
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

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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT02612324     History of Changes
Other Study ID Numbers: TP2AH000017
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by University of Hawaii:
adolescents
teen pregnancy prevention
sexually transmitted infections prevention
place-based programs
health education

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female