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NCT02612324 Clinical Trial

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

Sexually Transmitted Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02612324
Other study ID # TP2AH000017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date September 2015

Study information
Verified date November 2020
Source University of Hawaii
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1783
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 13 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Business as Usual
Teen pregnancy and STI prevention education left to the discretion of the school.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Hawaii IMPAQ International, LLC.

References & Publications (4)

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. — View 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. — View 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. — View 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

Outcome
Type Measure Description Time frame Safety issue
Other Knowledge related to pregnancy & STI prevention assessed by the percent of pregnancy and STI prevention knowledge items on the questionnaire answered correctly. 1 year
Other 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
Other 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
Other Intentions to have sex assessed by the scale response on the questionnaire on intention to have sex in the next 12 months. 1 year
Primary Initiation of sexual activity assessed by the percent reporting on the questionnaire that they have had sexual intercourse. 1 year
Secondary 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
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