Internet-Based Sexual Health Education for Middle School Native American Youth
NCT ID: NCT01303575
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
574 participants
INTERVENTIONAL
2010-09-30
2015-01-31
Brief Summary
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Detailed Description
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During year 1 (Fall 2010 through Spring 2011) of this project, the study team will test the usability of the existing IYG program, while performing an assessment of existing programs for cultural of the IYG intervention. In year 2 (beginning Fall 2011), the project team plans to initiate and complete development of the cultural-adapted IYG intervention for AI/AN youth (IYG-AI/AN). Starting in year 3 (Fall 2012), the study efficacy trial will commence to evaluate the effectiveness of IYG-AI/AN on sexual behaviors and psychosocial determinants of those behaviors among AI/AN youth in three regions (Alaska, the Pacific Northwest, including Idaho, Oregon, and Washington state, and Arizona) relative to a comparison condition. Recruitment sites will be middle schools and Boys and Girls Clubs (BGCs), identified through their affiliations with the Alaska Native Tribal Health Consortium (ANTHC), the Pacific Northwest Tribal Epicenter (the Epicenter) and the Inter Tribal Council of Arizona (ITCA). Randomization will occur regionally, at the site (schools and BGCs) level, to one of two conditions: IYG-AI/AN and a comparison condition. The comparison condition will consist of two web-based educational programs unrelated to sexual health. The IYG-AI/AN intervention will be compared against the comparison condition. The efficacy trial will continue for 16 months into year 4 (2013).
The primary hypothesis to be tested is: (1) youth who receive the IYG-AI/AN intervention will delay sexual activity relative to those who receive the comparison condition. The major dependent variable is the proportion of AI/AN youth initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine the effect of the intervention on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as youth intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also examine the effect of the intervention on the proportion of AI/AN youth who are sexually active, occurrences of unprotected sexual intercourse and the number of sexual partners among these AI/AN youth.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HIV, STI, and Pregnancy Prevention Curriculum
HIV, STI and Pregnancy Prevention Curriculum
A complete internet-based, "It's Your Game...Keep It Real" Intervention Program
Control curricula: Science Education
No sexual health elements
Control Curricula
A computer-based, science education program that does not contain elements of sexual health education
Interventions
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HIV, STI and Pregnancy Prevention Curriculum
A complete internet-based, "It's Your Game...Keep It Real" Intervention Program
Control Curricula
A computer-based, science education program that does not contain elements of sexual health education
Eligibility Criteria
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Inclusion Criteria
* Youth ages 12-14 attending regular classes in regional middle schools or youth attending after-school programs and/or Boys and Girls Clubs
* English-speaking
Exclusion Criteria
* Any physical or mental condition that would inhibit the ability to complete surveys and use computer programs, such as cognitive impairment, motor disorders (e.g. quadriplegia), learning difficulties or psychiatric/behavioral problems (e.g. autism, attention deficit disorder)
* Students will be informed that the surveys and intervention materials will only be available in English and will be asked to consider their comfort level with participating in the study
12 Years
14 Years
ALL
Yes
Sponsors
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Alaska Native Tribal Health Consortium
OTHER
Inter Tribal Council of Arizona
UNKNOWN
Northwest Portland Area Indian Health Board
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Ross Shegog
Associate Professor - School of Public Health
Principal Investigators
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Ross Shegog, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Christine Markham, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Melissa Peskin, DrPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Cornelia Jessen, MA
Role: PRINCIPAL_INVESTIGATOR
Alaska Native Tribal Health Consortium
Stephanie Craig-Rushing, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwest Portland Area Indian Health Board
Gwenda Gorman
Role: PRINCIPAL_INVESTIGATOR
Inter Tribal Council of Arizona, Inc.
Scott Tulloch
Role: PRINCIPAL_INVESTIGATOR
Indian Health Service (IHS)
Locations
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Alaska Native Tribal Health Consortium
Anchorage, Alaska, United States
Inter Tribal Council of Arizona, Inc.
Phoenix, Arizona, United States
Northwest Portland Area Indian Health Board
Portland, Oregon, United States
University of Texas Health Science Center, Houston
Houston, Texas, United States
Countries
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References
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Markham CM, Craig Rushing S, Jessen C, Gorman G, Torres J, Lambert WE, Prokhorov AV, Miller L, Allums-Featherston K, Addy RC, Peskin MF, Shegog R. Internet-Based Delivery of Evidence-Based Health Promotion Programs Among American Indian and Alaska Native Youth: A Case Study. JMIR Res Protoc. 2016 Nov 21;5(4):e225. doi: 10.2196/resprot.6017.
Other Identifiers
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