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

HIV Infections Clinical Trial

— IYG-AI/AN  

Official title:

It's Your Game...Keep It Real for American Indian/Alaska Native Youth: Innovative Approaches to Prevent Teen Pregnancy Among Underserved Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303575
• Other study ID #: 5U48DP001949
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: June 22, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: November 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy
• Sexually Transmitted Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Alaska Native Tribal Health Consortium	Anchorage	Alaska
United States	University of Texas Health Science Center, Houston	Houston	Texas
United States	Inter Tribal Council of Arizona, Inc.	Phoenix	Arizona
United States	Northwest Portland Area Indian Health Board	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Alaska Native Tribal Health Consortium, Inter Tribal Council of Arizona, Northwest Portland Area Indian Health Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay onset of sexual activity	delay onset of vaginal, oral or anal sex	baseline	No
Primary	Delay onset of sexual activity	delay onset of vaginal, oral or anal sex	5-months	No
Primary	Delay onset of sexual activity	delay onset of vaginal, oral or anal sex	16-months	No
Secondary	Reduce alcohol/drug use		baseline	No
Secondary	Reduce instances of sexual activity		baseline	No
Secondary	Decrease the number of sexual partners		baseline	No
Secondary	Condom use during sexual activity		baseline	No
Secondary	Contraceptive use while sexually active		baseline	No
Secondary	Prevalence of sexually transmitted infections		baseline	No
Secondary	Increase sexual knowledge		baseline	No
Secondary	Changes in sexual beliefs		baseline	No
Secondary	Changes in attitudes toward sexual activity		baseline	No
Secondary	Changes in perception of sexual beliefs among peers		baseline	No
Secondary	Increased self-efficacy for refusal skills		baseline	No
Secondary	Increased self-efficacy for condom use		baseline	No
Secondary	Increased avoidance of risky situations		baseline	No
Secondary	Changes in perceived norms about sexual activity		baseline	No
Secondary	Changes in reasons for or against having sex		baseline	No
Secondary	Changes in intentions to have/abstain from sex		baseline	No
Secondary	Reduce alcohol/drug use		5-months	No
Secondary	Reduce alcohol/drug use		16-months	No
Secondary	Reduce instances of sexual activity		5-months	No
Secondary	Reduce instances of sexual activity		16-months	No
Secondary	Decrease the number of sexual partners		5-months	No
Secondary	Decrease the number of sexual partners		16-months	No
Secondary	Condom use during sexual activity		5-months	No
Secondary	Condom use during sexual activity		16-months	No
Secondary	Contraceptive use while sexually active		5-months	No
Secondary	Prevalence of sexually transmitted infections		5-months	No
Secondary	Prevalence of sexually transmitted infections		16-months	No
Secondary	Increase sexual knowledge		5-months	No
Secondary	Increase sexual knowledge		16-months	No
Secondary	Changes in sexual beliefs		5-months	No
Secondary	Changes in sexual beliefs		16-months	No
Secondary	Changes in attitudes toward sexual activity		5-months	No
Secondary	Changes in attitudes toward sexual activity		16-months	No
Secondary	Changes in perception of sexual beliefs among peers		5-months	No
Secondary	Changes in perception of sexual beliefs among peers		16-months	No
Secondary	Increased self-efficacy for refusal skills		5-months	No
Secondary	Increased self-efficacy for refusal skills		16-months	No
Secondary	Increased self-efficacy for condom use		5-months	No
Secondary	Increased self-efficacy for condom use		16-months	No
Secondary	Increased avoidance of risky situations		5-months	No
Secondary	Increased avoidance of risky situations		16-months	No
Secondary	Changes in perceived norms about sexual activity		5-months	No
Secondary	Changes in perceived norms about sexual activity		16-months	No
Secondary	Changes in reasons for or against having sex		5-months	No
Secondary	Changes in reasons for or against having sex		16-months	No
Secondary	Changes in intentions to have/abstain from sex		5-months	No
Secondary	Changes in intentions to have/abstain from sex		16-months	No