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
|Condition or disease||Intervention/treatment||Phase|
|Teen Pregnancy Sexually Transmitted Infections||Behavioral: Pono Choices Behavioral: Business as Usual||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1783 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
- Initiation of sexual activity assessed by the percent reporting on the questionnaire that they have had sexual intercourse. [ Time Frame: 1 year ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
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
|Principal Investigator:||Kelly D Roberts, PhD||University of Hawaii at Manoa|