This study will evaluate the effect of an American Indian/Alaska Native (AI/AN) adaptation of the It's Your Game…Keep It Real (IYG) intervention, relative to a comparison condition on sexual behavior outcomes and psychosocial variables for middle school aged youth (12 - 14 years old). The original IYG program was designed for students in Houston middle schools to help students delay sexual initiation and if sexually active, use condoms and contraception. The present study will adapt the existing IYG program for an AI/AN youth cohort; the original IYG curriculum will be transferred into a web-based format and modified to incorporate additional culturally-relevant components. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity. Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex and psychosocial variables related to sexual risk-taking behavior. This project will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.
The goal of this four year research project is to adapt and evaluate the effectiveness of an Internet-based HIV/STI, and pregnancy prevention curriculum for American Indian/Alaska Native (AI/AN) middle school-aged youth (12-14 years). This curriculum will be adapted from a successful, Internet-accessible, prevention program, It's Your Game…Keep it Real (IYG). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
574
A complete internet-based, "It's Your Game...Keep It Real" Intervention Program
A computer-based, science education program that does not contain elements of sexual health education
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
Delay onset of sexual activity
delay onset of vaginal, oral or anal sex
Time frame: baseline
Delay onset of sexual activity
delay onset of vaginal, oral or anal sex
Time frame: 5-months
Delay onset of sexual activity
delay onset of vaginal, oral or anal sex
Time frame: 16-months
Reduce alcohol/drug use
Time frame: baseline
Reduce instances of sexual activity
Time frame: baseline
Decrease the number of sexual partners
Time frame: baseline
Condom use during sexual activity
Time frame: baseline
Contraceptive use while sexually active
Time frame: baseline
Prevalence of sexually transmitted infections
Time frame: baseline
Increase sexual knowledge
Time frame: baseline
Changes in sexual beliefs
Time frame: baseline
Changes in attitudes toward sexual activity
Time frame: baseline
Changes in perception of sexual beliefs among peers
Time frame: baseline
Increased self-efficacy for refusal skills
Time frame: baseline
Increased self-efficacy for condom use
Time frame: baseline
Increased avoidance of risky situations
Time frame: baseline
Changes in perceived norms about sexual activity
Time frame: baseline
Changes in reasons for or against having sex
Time frame: baseline
Changes in intentions to have/abstain from sex
Time frame: baseline
Reduce alcohol/drug use
Time frame: 5-months
Reduce alcohol/drug use
Time frame: 16-months
Reduce instances of sexual activity
Time frame: 5-months
Reduce instances of sexual activity
Time frame: 16-months
Decrease the number of sexual partners
Time frame: 5-months
Decrease the number of sexual partners
Time frame: 16-months
Condom use during sexual activity
Time frame: 5-months
Condom use during sexual activity
Time frame: 16-months
Contraceptive use while sexually active
Time frame: 5-months
Prevalence of sexually transmitted infections
Time frame: 5-months
Prevalence of sexually transmitted infections
Time frame: 16-months
Increase sexual knowledge
Time frame: 5-months
Increase sexual knowledge
Time frame: 16-months
Changes in sexual beliefs
Time frame: 5-months
Changes in sexual beliefs
Time frame: 16-months
Changes in attitudes toward sexual activity
Time frame: 5-months
Changes in attitudes toward sexual activity
Time frame: 16-months
Changes in perception of sexual beliefs among peers
Time frame: 5-months
Changes in perception of sexual beliefs among peers
Time frame: 16-months
Increased self-efficacy for refusal skills
Time frame: 5-months
Increased self-efficacy for refusal skills
Time frame: 16-months
Increased self-efficacy for condom use
Time frame: 5-months
Increased self-efficacy for condom use
Time frame: 16-months
Increased avoidance of risky situations
Time frame: 5-months
Increased avoidance of risky situations
Time frame: 16-months
Changes in perceived norms about sexual activity
Time frame: 5-months
Changes in perceived norms about sexual activity
Time frame: 16-months
Changes in reasons for or against having sex
Time frame: 5-months
Changes in reasons for or against having sex
Time frame: 16-months
Changes in intentions to have/abstain from sex
Time frame: 5-months
Changes in intentions to have/abstain from sex
Time frame: 16-months
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