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

Primary Purpose

Sexually Transmitted Diseases, Pregnancy, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV, STI and Pregnancy Prevention Curriculum
Control Curricula
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Adolescents, Youth, Sexual Health, Sex Education, Pregnancy Prevention, Abstinence Education, HIV, Human Immunodeficiency Virus, STI, Chlamydia, Gonorrhea, Sexually Transmitted Infections, American Indian, Alaska Native, Native American, Internet-Based, Computer-based Education, Computer-based learning

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alaska Native Tribal Health Consortium
  • Inter Tribal Council of Arizona, Inc.
  • Northwest Portland Area Indian Health Board
  • University of Texas Health Science Center, Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIV, STI, and Pregnancy Prevention Curriculum

Control curricula: Science Education

Arm Description

No sexual health elements

Outcomes

Primary Outcome Measures

Delay onset of sexual activity
delay onset of vaginal, oral or anal sex
Delay onset of sexual activity
delay onset of vaginal, oral or anal sex
Delay onset of sexual activity
delay onset of vaginal, oral or anal sex

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2011
Last Updated
June 22, 2015
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Alaska Native Tribal Health Consortium, Inter Tribal Council of Arizona, Northwest Portland Area Indian Health Board
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1. Study Identification

Unique Protocol Identification Number
NCT01303575
Brief Title
Internet-Based Sexual Health Education for Middle School Native American Youth
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Alaska Native Tribal Health Consortium, Inter Tribal Council of Arizona, Northwest Portland Area Indian Health Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Pregnancy, HIV Infections
Keywords
Adolescents, Youth, Sexual Health, Sex Education, Pregnancy Prevention, Abstinence Education, HIV, Human Immunodeficiency Virus, STI, Chlamydia, Gonorrhea, Sexually Transmitted Infections, American Indian, Alaska Native, Native American, Internet-Based, Computer-based Education, Computer-based learning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
574 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV, STI, and Pregnancy Prevention Curriculum
Arm Type
Experimental
Arm Title
Control curricula: Science Education
Arm Type
Active Comparator
Arm Description
No sexual health elements
Intervention Type
Behavioral
Intervention Name(s)
HIV, STI and Pregnancy Prevention Curriculum
Intervention Description
A complete internet-based, "It's Your Game...Keep It Real" Intervention Program
Intervention Type
Behavioral
Intervention Name(s)
Control Curricula
Intervention Description
A computer-based, science education program that does not contain elements of sexual health education
Primary Outcome Measure Information:
Title
Delay onset of sexual activity
Description
delay onset of vaginal, oral or anal sex
Time Frame
baseline
Title
Delay onset of sexual activity
Description
delay onset of vaginal, oral or anal sex
Time Frame
5-months
Title
Delay onset of sexual activity
Description
delay onset of vaginal, oral or anal sex
Time Frame
16-months
Secondary Outcome Measure Information:
Title
Reduce alcohol/drug use
Time Frame
baseline
Title
Reduce instances of sexual activity
Time Frame
baseline
Title
Decrease the number of sexual partners
Time Frame
baseline
Title
Condom use during sexual activity
Time Frame
baseline
Title
Contraceptive use while sexually active
Time Frame
baseline
Title
Prevalence of sexually transmitted infections
Time Frame
baseline
Title
Increase sexual knowledge
Time Frame
baseline
Title
Changes in sexual beliefs
Time Frame
baseline
Title
Changes in attitudes toward sexual activity
Time Frame
baseline
Title
Changes in perception of sexual beliefs among peers
Time Frame
baseline
Title
Increased self-efficacy for refusal skills
Time Frame
baseline
Title
Increased self-efficacy for condom use
Time Frame
baseline
Title
Increased avoidance of risky situations
Time Frame
baseline
Title
Changes in perceived norms about sexual activity
Time Frame
baseline
Title
Changes in reasons for or against having sex
Time Frame
baseline
Title
Changes in intentions to have/abstain from sex
Time Frame
baseline
Title
Reduce alcohol/drug use
Time Frame
5-months
Title
Reduce alcohol/drug use
Time Frame
16-months
Title
Reduce instances of sexual activity
Time Frame
5-months
Title
Reduce instances of sexual activity
Time Frame
16-months
Title
Decrease the number of sexual partners
Time Frame
5-months
Title
Decrease the number of sexual partners
Time Frame
16-months
Title
Condom use during sexual activity
Time Frame
5-months
Title
Condom use during sexual activity
Time Frame
16-months
Title
Contraceptive use while sexually active
Time Frame
5-months
Title
Prevalence of sexually transmitted infections
Time Frame
5-months
Title
Prevalence of sexually transmitted infections
Time Frame
16-months
Title
Increase sexual knowledge
Time Frame
5-months
Title
Increase sexual knowledge
Time Frame
16-months
Title
Changes in sexual beliefs
Time Frame
5-months
Title
Changes in sexual beliefs
Time Frame
16-months
Title
Changes in attitudes toward sexual activity
Time Frame
5-months
Title
Changes in attitudes toward sexual activity
Time Frame
16-months
Title
Changes in perception of sexual beliefs among peers
Time Frame
5-months
Title
Changes in perception of sexual beliefs among peers
Time Frame
16-months
Title
Increased self-efficacy for refusal skills
Time Frame
5-months
Title
Increased self-efficacy for refusal skills
Time Frame
16-months
Title
Increased self-efficacy for condom use
Time Frame
5-months
Title
Increased self-efficacy for condom use
Time Frame
16-months
Title
Increased avoidance of risky situations
Time Frame
5-months
Title
Increased avoidance of risky situations
Time Frame
16-months
Title
Changes in perceived norms about sexual activity
Time Frame
5-months
Title
Changes in perceived norms about sexual activity
Time Frame
16-months
Title
Changes in reasons for or against having sex
Time Frame
5-months
Title
Changes in reasons for or against having sex
Time Frame
16-months
Title
Changes in intentions to have/abstain from sex
Time Frame
5-months
Title
Changes in intentions to have/abstain from sex
Time Frame
16-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Shegog, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Markham, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melissa Peskin, DrPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cornelia Jessen, MA
Organizational Affiliation
Alaska Native Tribal Health Consortium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephanie Craig-Rushing, MPH, PhD
Organizational Affiliation
Northwest Portland Area Indian Health Board
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gwenda Gorman
Organizational Affiliation
Inter Tribal Council of Arizona, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Tulloch
Organizational Affiliation
Indian Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Native Tribal Health Consortium
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Inter Tribal Council of Arizona, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Northwest Portland Area Indian Health Board
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Texas Health Science Center, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27872037
Citation
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.
Results Reference
derived

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

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