Internet-Based Sexual Health Education for Middle School Native American Youth (IYG-AI/AN)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases; Pregnancy
• Intervention / Treatment: Behavioral: HIV, STI and Pregnancy Prevention Curriculum; Behavioral: Control Curricula

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.

• Study Type: Interventional
• Enrollment (Actual): 574
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Native Tribal Health Consortium
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Inter Tribal Council of Arizona, Inc.
  • Oregon
    • Portland, Oregon, United States, 97201
      • Northwest Portland Area Indian Health Board
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center, Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV, STI, and Pregnancy Prevention Curriculum	Behavioral: HIV, STI and Pregnancy Prevention Curriculum; A complete internet-based, "It's Your Game...Keep It Real" Intervention Program
Active Comparator: Control curricula: Science Education; No sexual health elements	Behavioral: Control Curricula; A computer-based, science education program that does not contain elements of sexual health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay onset of sexual activity	delay onset of vaginal, oral or anal sex	baseline
Delay onset of sexual activity	delay onset of vaginal, oral or anal sex	5-months
Delay onset of sexual activity	delay onset of vaginal, oral or anal sex	16-months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduce alcohol/drug use	baseline
Reduce instances of sexual activity	baseline
Decrease the number of sexual partners	baseline
Condom use during sexual activity	baseline
Contraceptive use while sexually active	baseline
Prevalence of sexually transmitted infections	baseline
Increase sexual knowledge	baseline
Changes in sexual beliefs	baseline
Changes in attitudes toward sexual activity	baseline
Changes in perception of sexual beliefs among peers	baseline
Increased self-efficacy for refusal skills	baseline
Increased self-efficacy for condom use	baseline
Increased avoidance of risky situations	baseline
Changes in perceived norms about sexual activity	baseline
Changes in reasons for or against having sex	baseline
Changes in intentions to have/abstain from sex	baseline
Reduce alcohol/drug use	5-months
Reduce alcohol/drug use	16-months
Reduce instances of sexual activity	5-months
Reduce instances of sexual activity	16-months
Decrease the number of sexual partners	5-months
Decrease the number of sexual partners	16-months
Condom use during sexual activity	5-months
Condom use during sexual activity	16-months
Contraceptive use while sexually active	5-months
Prevalence of sexually transmitted infections	5-months
Prevalence of sexually transmitted infections	16-months
Increase sexual knowledge	5-months
Increase sexual knowledge	16-months
Changes in sexual beliefs	5-months
Changes in sexual beliefs	16-months
Changes in attitudes toward sexual activity	5-months
Changes in attitudes toward sexual activity	16-months
Changes in perception of sexual beliefs among peers	5-months
Changes in perception of sexual beliefs among peers	16-months
Increased self-efficacy for refusal skills	5-months
Increased self-efficacy for refusal skills	16-months
Increased self-efficacy for condom use	5-months
Increased self-efficacy for condom use	16-months
Increased avoidance of risky situations	5-months
Increased avoidance of risky situations	16-months
Changes in perceived norms about sexual activity	5-months
Changes in perceived norms about sexual activity	16-months
Changes in reasons for or against having sex	5-months
Changes in reasons for or against having sex	16-months
Changes in intentions to have/abstain from sex	5-months
Changes in intentions to have/abstain from sex	16-months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Alaska Native Tribal Health Consortium; Northwest Portland Area Indian Health Board; Inter Tribal Council of Arizona
• Investigators: Principal Investigator: Ross Shegog, PhD, The University of Texas Health Science Center, Houston; Principal Investigator: Melissa Peskin, DrPH, The University of Texas Health Science Center, Houston; Principal Investigator: Cornelia Jessen, MA, Alaska Native Tribal Health Consortium; Principal Investigator: Stephanie Craig-Rushing, MPH, PhD, Northwest Portland Area Indian Health Board; Principal Investigator: Gwenda Gorman, Inter Tribal Council of Arizona, Inc.; Principal Investigator: Scott Tulloch, Indian Health Service

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Adolescents; HIV; Chlamydia; Gonorrhea; STI; Human Immunodeficiency Virus; Alaska Native; Youth; Sexual Health; Native American; Sexually Transmitted Infections; American Indian; Sex Education; Internet-Based; Pregnancy Prevention; Abstinence Education; Computer-based Education; Computer-based learning
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 5U48DP001949 (U.S. NIH Grant/Contract)