HIV Infections Clinical Trial
Official title:
It's Your Game...Keep It Real for American Indian/Alaska Native Youth: Innovative Approaches to Prevent Teen Pregnancy Among Underserved Populations
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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