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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
Alaska Native Tribal Health Consortium
Inter Tribal Council of Arizona
Northwest Portland Area Indian Health Board
Information provided by (Responsible Party):
Ross Shegog, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01303575
First received: February 18, 2011
Last updated: May 4, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Sexually Transmitted Diseases
Pregnancy
HIV Infections
Behavioral: HIV, STI and Pregnancy Prevention Curriculum
Behavioral: Control Curricula

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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Delay onset of sexual activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    delay onset of vaginal, oral or anal sex

  • Delay onset of sexual activity [ Time Frame: 5-months ] [ Designated as safety issue: No ]
    delay onset of vaginal, oral or anal sex

  • Delay onset of sexual activity [ Time Frame: 16-months ] [ Designated as safety issue: No ]
    delay onset of vaginal, oral or anal sex


Secondary Outcome Measures:
  • Reduce alcohol/drug use [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Reduce instances of sexual activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Decrease the number of sexual partners [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Condom use during sexual activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Contraceptive use while sexually active [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Prevalence of sexually transmitted infections [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Increase sexual knowledge [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Changes in sexual beliefs [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Changes in attitudes toward sexual activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Changes in perception of sexual beliefs among peers [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Increased self-efficacy for refusal skills [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Increased self-efficacy for condom use [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Increased avoidance of risky situations [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Changes in perceived norms about sexual activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Changes in reasons for or against having sex [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Changes in intentions to have/abstain from sex [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Reduce alcohol/drug use [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Reduce alcohol/drug use [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Reduce instances of sexual activity [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Reduce instances of sexual activity [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Decrease the number of sexual partners [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Decrease the number of sexual partners [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Condom use during sexual activity [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Condom use during sexual activity [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Contraceptive use while sexually active [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Prevalence of sexually transmitted infections [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Prevalence of sexually transmitted infections [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Increase sexual knowledge [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Increase sexual knowledge [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Changes in sexual beliefs [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Changes in sexual beliefs [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Changes in attitudes toward sexual activity [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Changes in attitudes toward sexual activity [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Changes in perception of sexual beliefs among peers [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Changes in perception of sexual beliefs among peers [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Increased self-efficacy for refusal skills [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Increased self-efficacy for refusal skills [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Increased self-efficacy for condom use [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Increased self-efficacy for condom use [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Increased avoidance of risky situations [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Increased avoidance of risky situations [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Changes in perceived norms about sexual activity [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Changes in perceived norms about sexual activity [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Changes in reasons for or against having sex [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Changes in reasons for or against having sex [ Time Frame: 16-months ] [ Designated as safety issue: No ]
  • Changes in intentions to have/abstain from sex [ Time Frame: 5-months ] [ Designated as safety issue: No ]
  • Changes in intentions to have/abstain from sex [ Time Frame: 16-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: September 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303575

Contacts
Contact: Ross Shegog, PhD (713) 500-9677 Ross.Shegog@uth.tmc.edu
Contact: Christine Markham, PhD (713) 500-9646 Christine.Markham@uth.tmc.edu

Locations
United States, Alaska
Alaska Native Tribal Health Consortium Not yet recruiting
Anchorage, Alaska, United States, 99508
Contact: Cornelia Jessen, MA    907-729-3955      
Principal Investigator: Cornelia Jessen, MA         
United States, Arizona
Inter Tribal Council of Arizona, Inc. Not yet recruiting
Phoenix, Arizona, United States, 85004
Contact: Gwenda Gorman    602-258-4822      
Principal Investigator: Gwenda Gorman         
United States, Oregon
Northwest Portland Area Indian Health Board Recruiting
Portland, Oregon, United States, 97201
Contact: Stephanie Craig-Rushing, MPH, PhD    503-416-3290      
Principal Investigator: Stephanie Craig-Rushing, MPH, PhD         
United States, Texas
University of Texas Health Science Center, Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Ross Shegog, PhD    713-500-9677      
Principal Investigator: Ross Shegog, PhD         
Principal Investigator: Christine Markham, PhD         
Principal Investigator: Melissa Peskin, MPH, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Alaska Native Tribal Health Consortium
Inter Tribal Council of Arizona
Northwest Portland Area Indian Health Board
Investigators
Principal Investigator: Ross Shegog, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Christine Markham, 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
  More Information

No publications provided

Responsible Party: Ross Shegog, Associate Professor - School of Public Health, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01303575     History of Changes
Other Study ID Numbers: 5U48DP001949
Study First Received: February 18, 2011
Last Updated: May 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
HIV
Human Immunodeficiency Virus
Adolescents
Youth
Sexual Health
Sex Education
Pregnancy Prevention
Abstinence Education
STI
Chlamydia
Gonorrhea
Sexually Transmitted Infections
American Indian
Alaska Native
Native American
Internet-Based
Computer-based Education
Computer-based learning

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014