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Sexually Transmitted DiseasesIYG-AI/ANNCT01303575

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

A study testing HIV, STI and Pregnancy Prevention Curriculum in people with Sexually Transmitted Diseases and Pregnancy, run by The University of Texas Health Science Center, Houston at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 to 14 yearsHealthy volunteers can take part
What is being tested?
HIV, STI and Pregnancy Prevention Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
574 participants
Where
4 sitesUnited States
Study dates
Sep 2010to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Alaska Native Tribal Health Consortium

    Anchorage, Alaska, 99508

  • University of Texas Health Science Center, Houston

    Houston, Texas, 77030

  • Inter Tribal Council of Arizona, Inc.

    Phoenix, Arizona, 85004

  • Northwest Portland Area Indian Health Board

    Portland, Oregon, 97201

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
HIV, STI and Pregnancy Prevention Curriculum, Control Curricula
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
Medical subject headings
Sexually Transmitted Diseases, HIV Infections, Acquired Immunodeficiency Syndrome, Chlamydia Infections, Gonorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV, STI and Pregnancy Prevention CurriculumBehavioural

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

  • Control CurriculaBehavioural

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

Study groups in NCT01303575
Study groupRoleWhat they receive
HIV, STI, and Pregnancy Prevention CurriculumExperimentalNot described
Receives: Behavioral: HIV, STI and Pregnancy Prevention Curriculum
Control curricula: Science EducationActive comparatorNo sexual health elements
Receives: Behavioral: Control Curricula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delay onset of sexual activity

    delay onset of vaginal, oral or anal sex

    Measured: baseline

  2. Delay onset of sexual activity

    delay onset of vaginal, oral or anal sex

    Measured: 5-months

  3. Delay onset of sexual activity

    delay onset of vaginal, oral or anal sex

    Measured: 16-months

Secondary outcomes (47)

  1. Reduce alcohol/drug use

    Measured: baseline

  2. Reduce instances of sexual activity

    Measured: baseline

  3. Decrease the number of sexual partners

    Measured: baseline

  4. Condom use during sexual activity

    Measured: baseline

  5. Contraceptive use while sexually active

    Measured: baseline

  6. Prevalence of sexually transmitted infections

    Measured: baseline

  7. Increase sexual knowledge

    Measured: baseline

  8. Changes in sexual beliefs

    Measured: baseline

  9. Changes in attitudes toward sexual activity

    Measured: baseline

  10. Changes in perception of sexual beliefs among peers

    Measured: baseline

  11. Increased self-efficacy for refusal skills

    Measured: baseline

  12. Increased self-efficacy for condom use

    Measured: baseline

  13. Increased avoidance of risky situations

    Measured: baseline

  14. Changes in perceived norms about sexual activity

    Measured: baseline

  15. Changes in reasons for or against having sex

    Measured: baseline

  16. Changes in intentions to have/abstain from sex

    Measured: baseline

  17. Reduce alcohol/drug use

    Measured: 5-months

  18. Reduce alcohol/drug use

    Measured: 16-months

  19. Reduce instances of sexual activity

    Measured: 5-months

  20. Reduce instances of sexual activity

    Measured: 16-months

  21. Decrease the number of sexual partners

    Measured: 5-months

  22. Decrease the number of sexual partners

    Measured: 16-months

  23. Condom use during sexual activity

    Measured: 5-months

  24. Condom use during sexual activity

    Measured: 16-months

  25. Contraceptive use while sexually active

    Measured: 5-months

  26. Prevalence of sexually transmitted infections

    Measured: 5-months

  27. Prevalence of sexually transmitted infections

    Measured: 16-months

  28. Increase sexual knowledge

    Measured: 5-months

  29. Increase sexual knowledge

    Measured: 16-months

  30. Changes in sexual beliefs

    Measured: 5-months

  31. Changes in sexual beliefs

    Measured: 16-months

  32. Changes in attitudes toward sexual activity

    Measured: 5-months

  33. Changes in attitudes toward sexual activity

    Measured: 16-months

  34. Changes in perception of sexual beliefs among peers

    Measured: 5-months

  35. Changes in perception of sexual beliefs among peers

    Measured: 16-months

  36. Increased self-efficacy for refusal skills

    Measured: 5-months

  37. Increased self-efficacy for refusal skills

    Measured: 16-months

  38. Increased self-efficacy for condom use

    Measured: 5-months

  39. Increased self-efficacy for condom use

    Measured: 16-months

  40. Increased avoidance of risky situations

    Measured: 5-months

  41. Increased avoidance of risky situations

    Measured: 16-months

  42. Changes in perceived norms about sexual activity

    Measured: 5-months

  43. Changes in perceived norms about sexual activity

    Measured: 16-months

  44. Changes in reasons for or against having sex

    Measured: 5-months

  45. Changes in reasons for or against having sex

    Measured: 16-months

  46. Changes in intentions to have/abstain from sex

    Measured: 5-months

  47. Changes in intentions to have/abstain from sex

    Measured: 16-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
574 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303575
Sponsor's protocol ID
5U48DP001949
Acronym
IYG-AI/AN
Status last verified
Nov 2013
First submitted
18 Feb 2011
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27872037

Questions about this trial

What is this clinical trial studying?

A study testing HIV, STI and Pregnancy Prevention Curriculum in people with Sexually Transmitted Diseases and Pregnancy, run by The University of Texas Health Science Center, Houston at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delay onset of sexual activity (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01303575, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.

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