Clinical trial NCT01303575: Internet-Based Sexual Health Education for Middle School Native American Youth
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Alaska Native Tribal Health Consortium
name: Inter Tribal Council of Arizona
name: Northwest Portland Area Indian Health Board
First posted: 2011-02-24
Enrollment: 574
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Delay onset of sexual activity
timeFrame: baseline
measure: Delay onset of sexual activity
timeFrame: 5-months
measure: Delay onset of sexual activity
timeFrame: 16-months
Secondary outcomes:
measure: Reduce alcohol/drug use
timeFrame: baseline
measure: Reduce instances of sexual activity
timeFrame: baseline
measure: Decrease the number of sexual partners
timeFrame: baseline
measure: Condom use during sexual activity
timeFrame: baseline
measure: Contraceptive use while sexually active
timeFrame: baseline
measure: Prevalence of sexually transmitted infections
timeFrame: baseline
measure: Increase sexual knowledge
timeFrame: baseline
measure: Changes in sexual beliefs
timeFrame: baseline
measure: Changes in attitudes toward sexual activity
timeFrame: baseline
measure: Changes in perception of sexual beliefs among peers
timeFrame: baseline
measure: Increased self-efficacy for refusal skills
timeFrame: baseline
measure: Increased self-efficacy for condom use
timeFrame: baseline
measure: Increased avoidance of risky situations
timeFrame: baseline
measure: Changes in perceived norms about sexual activity
timeFrame: baseline
measure: Changes in reasons for or against having sex
timeFrame: baseline
measure: Changes in intentions to have/abstain from sex
timeFrame: baseline
measure: Reduce alcohol/drug use
timeFrame: 5-months
measure: Reduce alcohol/drug use
timeFrame: 16-months
measure: Reduce instances of sexual activity
timeFrame: 5-months
measure: Reduce instances of sexual activity
timeFrame: 16-months
measure: Decrease the number of sexual partners
timeFrame: 5-months
measure: Decrease the number of sexual partners
timeFrame: 16-months
measure: Condom use during sexual activity
timeFrame: 5-months
measure: Condom use during sexual activity
timeFrame: 16-months
measure: Contraceptive use while sexually active
timeFrame: 5-months
measure: Prevalence of sexually transmitted infections
timeFrame: 5-months
measure: Prevalence of sexually transmitted infections
timeFrame: 16-months
measure: Increase sexual knowledge
timeFrame: 5-months
measure: Increase sexual knowledge
timeFrame: 16-months
measure: Changes in sexual beliefs
timeFrame: 5-months
measure: Changes in sexual beliefs
timeFrame: 16-months
measure: Changes in attitudes toward sexual activity
timeFrame: 5-months
measure: Changes in attitudes toward sexual activity
timeFrame: 16-months
measure: Changes in perception of sexual beliefs among peers
timeFrame: 5-months
measure: Changes in perception of sexual beliefs among peers
timeFrame: 16-months
measure: Increased self-efficacy for refusal skills
timeFrame: 5-months
measure: Increased self-efficacy for refusal skills
timeFrame: 16-months
measure: Increased self-efficacy for condom use
timeFrame: 5-months
measure: Increased self-efficacy for condom use
timeFrame: 16-months
measure: Increased avoidance of risky situations
timeFrame: 5-months
measure: Increased avoidance of risky situations
timeFrame: 16-months
measure: Changes in perceived norms about sexual activity
timeFrame: 5-months
measure: Changes in perceived norms about sexual activity
timeFrame: 16-months
measure: Changes in reasons for or against having sex
timeFrame: 5-months
measure: Changes in reasons for or against having sex
timeFrame: 16-months
measure: Changes in intentions to have/abstain from sex
timeFrame: 5-months
measure: Changes in intentions to have/abstain from sex
timeFrame: 16-months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Native Tribal Health Consortium
state: Alaska
city: Phoenix
country: United States
facility: Inter Tribal Council of Arizona, Inc.
state: Arizona
city: Portland
country: United States
facility: Northwest Portland Area Indian Health Board
state: Oregon
city: Houston
country: United States
facility: University of Texas Health Science Center, Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ross Shegog, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Christine Markham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Melissa Peskin, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Alaska Native Tribal Health Consortium
name: Cornelia Jessen, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Portland Area Indian Health Board
name: Stephanie Craig-Rushing, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inter Tribal Council of Arizona, Inc.
name: Gwenda Gorman
role: PRINCIPAL_INVESTIGATOR
affiliation: Indian Health Service (IHS)
name: Scott Tulloch
role: PRINCIPAL_INVESTIGATOR
References:
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.