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Completed

NCT Number: NCT01303575

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV, STI and Pregnancy Prevention Curriculum

Behavioral

A complete internet-based, "It's Your Game...Keep It Real" Intervention Program

Control Curricula

Behavioral

A computer-based, science education program that does not contain elements of sexual health education

Primary outcomes

  1. Delay onset of sexual activity

    Time frame: baseline

    delay onset of vaginal, oral or anal sex

  2. Delay onset of sexual activity

    Time frame: 5-months

    delay onset of vaginal, oral or anal sex

  3. Delay onset of sexual activity

    Time frame: 16-months

    delay onset of vaginal, oral or anal sex

Secondary outcomes

  1. Reduce alcohol/drug use

    Time frame: baseline

  2. Reduce instances of sexual activity

    Time frame: baseline

  3. Decrease the number of sexual partners

    Time frame: baseline

  4. Condom use during sexual activity

    Time frame: baseline

  5. Contraceptive use while sexually active

    Time frame: baseline

  6. Prevalence of sexually transmitted infections

    Time frame: baseline

  7. Increase sexual knowledge

    Time frame: baseline

  8. Changes in sexual beliefs

    Time frame: baseline

  9. Changes in attitudes toward sexual activity

    Time frame: baseline

  10. Changes in perception of sexual beliefs among peers

    Time frame: baseline

  11. Increased self-efficacy for refusal skills

    Time frame: baseline

  12. Increased self-efficacy for condom use

    Time frame: baseline

  13. Increased avoidance of risky situations

    Time frame: baseline

  14. Changes in perceived norms about sexual activity

    Time frame: baseline

  15. Changes in reasons for or against having sex

    Time frame: baseline

  16. Changes in intentions to have/abstain from sex

    Time frame: baseline

  17. Reduce alcohol/drug use

    Time frame: 5-months

  18. Reduce alcohol/drug use

    Time frame: 16-months

  19. Reduce instances of sexual activity

    Time frame: 5-months

  20. Reduce instances of sexual activity

    Time frame: 16-months

  21. Decrease the number of sexual partners

    Time frame: 5-months

  22. Decrease the number of sexual partners

    Time frame: 16-months

  23. Condom use during sexual activity

    Time frame: 5-months

  24. Condom use during sexual activity

    Time frame: 16-months

  25. Contraceptive use while sexually active

    Time frame: 5-months

  26. Prevalence of sexually transmitted infections

    Time frame: 5-months

  27. Prevalence of sexually transmitted infections

    Time frame: 16-months

  28. Increase sexual knowledge

    Time frame: 5-months

  29. Increase sexual knowledge

    Time frame: 16-months

  30. Changes in sexual beliefs

    Time frame: 5-months

  31. Changes in sexual beliefs

    Time frame: 16-months

  32. Changes in attitudes toward sexual activity

    Time frame: 5-months

  33. Changes in attitudes toward sexual activity

    Time frame: 16-months

  34. Changes in perception of sexual beliefs among peers

    Time frame: 5-months

  35. Changes in perception of sexual beliefs among peers

    Time frame: 16-months

  36. Increased self-efficacy for refusal skills

    Time frame: 5-months

  37. Increased self-efficacy for refusal skills

    Time frame: 16-months

  38. Increased self-efficacy for condom use

    Time frame: 5-months

  39. Increased self-efficacy for condom use

    Time frame: 16-months

  40. Increased avoidance of risky situations

    Time frame: 5-months

  41. Increased avoidance of risky situations

    Time frame: 16-months

  42. Changes in perceived norms about sexual activity

    Time frame: 5-months

  43. Changes in perceived norms about sexual activity

    Time frame: 16-months

  44. Changes in reasons for or against having sex

    Time frame: 5-months

  45. Changes in reasons for or against having sex

    Time frame: 16-months

  46. Changes in intentions to have/abstain from sex

    Time frame: 5-months

  47. Changes in intentions to have/abstain from sex

    Time frame: 16-months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Alaska Native Tribal Health Consortium
  • Inter Tribal Council of Arizona
  • Northwest Portland Area Indian Health Board

Registry information

Official study title

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

Acronym: IYG-AI/AN

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2011
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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