Clinical trial NCT02612324: An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy
Sexually Transmitted Infections
Keywords: adolescents
teen pregnancy prevention
sexually transmitted infections prevention
place-based programs
health education
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: IMPAQ International, LLC.
First posted: 2015-11-23
Enrollment: 1783
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Initiation of sexual activity assessed by the percent reporting on the questionnaire that they have had sexual intercourse.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
measure: Knowledge related to pregnancy & STI prevention assessed by the percent of pregnancy and STI prevention knowledge items on the questionnaire answered correctly.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Intentions to have sex assessed by the scale response on the questionnaire on intention to have sex in the next 12 months.
timeFrame: 1 year
Locations:
Study officials:
affiliation: University of Hawaii at Manoa
name: Kelly D Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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
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.
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.