Internet-Based Sexual Health Education for Middle School Native American Youth (IYG-AI/AN)
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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 |
- 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
- 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 |
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| Contact: Ross Shegog, PhD | (713) 500-9677 | Ross.Shegog@uth.tmc.edu |
| Contact: Christine Markham, PhD | (713) 500-9646 | Christine.Markham@uth.tmc.edu |
| 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 | |
| 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:
|
Pregnancy Prevention Sexually Transmitted Infections Adolescents Youth Sexual Health Sex Education Abstinence Education HIV Human Immunodeficiency Virus |
STI Chlamydia Gonorrhea American Indian Alaska Native Native American Internet-Based Computer-based Education Computer-based learning |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Infection Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases |
Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013