Sexually Transmitted Infections Clinical Trial
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 |
Verified date | November 2020 |
Source | University of Hawaii |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Hawaii | IMPAQ International, LLC. |
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
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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