MedPath

Internet-Based Sexual Health Education for Middle School Native American Youth

Not Applicable
Completed
Conditions
Sexually Transmitted Diseases
Pregnancy
HIV Infections
Interventions
Behavioral: Control Curricula
Behavioral: HIV, STI and Pregnancy Prevention Curriculum
Registration Number
NCT01303575
Lead Sponsor
The University of Texas Health Science Center, Houston
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
574
Inclusion Criteria
  • American Indian or Alaska Native descent and/or tribal affiliation
  • 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
  • Youth who are not of American Indian or Alaska Native descent
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control curricula: Science EducationControl CurriculaNo sexual health elements
HIV, STI, and Pregnancy Prevention CurriculumHIV, STI and Pregnancy Prevention Curriculum-
Primary Outcome Measures
NameTimeMethod
Delay onset of sexual activity16-months

delay onset of vaginal, oral or anal sex

Secondary Outcome Measures
NameTimeMethod
Reduce alcohol/drug use16-months
Increased avoidance of risky situations16-months
Changes in perceived norms about sexual activity16-months
Decrease the number of sexual partners16-months
Condom use during sexual activity16-months
Increase sexual knowledge16-months
Changes in attitudes toward sexual activity16-months
Changes in perception of sexual beliefs among peers16-months
Changes in intentions to have/abstain from sex16-months
Reduce instances of sexual activity16-months
Contraceptive use while sexually active5-months
Prevalence of sexually transmitted infections16-months
Changes in sexual beliefs16-months
Increased self-efficacy for refusal skills16-months
Changes in reasons for or against having sex16-months
Increased self-efficacy for condom use16-months

Trial Locations

Locations (4)

Alaska Native Tribal Health Consortium

🇺🇸

Anchorage, Alaska, United States

University of Texas Health Science Center, Houston

🇺🇸

Houston, Texas, United States

Northwest Portland Area Indian Health Board

🇺🇸

Portland, Oregon, United States

Inter Tribal Council of Arizona, Inc.

🇺🇸

Phoenix, Arizona, United States

© Copyright 2025. All Rights Reserved by MedPath