NCT01303575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
574

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

November 1, 2013

Enrollment Period

4.3 years

First QC Date

February 18, 2011

Last Update Submit

June 22, 2015

Conditions

Sexually Transmitted DiseasesPregnancyHIV Infections

Keywords

AdolescentsYouthSexual HealthSex EducationPregnancy PreventionAbstinence EducationHIVHuman Immunodeficiency VirusSTIChlamydiaGonorrheaSexually Transmitted InfectionsAmerican IndianAlaska NativeNative AmericanInternet-BasedComputer-based EducationComputer-based learning

Outcome Measures

Primary Outcomes (3)

  • Delay onset of sexual activity

    delay onset of vaginal, oral or anal sex

    baseline

  • Delay onset of sexual activity

    delay onset of vaginal, oral or anal sex

    5-months

  • Delay onset of sexual activity

    delay onset of vaginal, oral or anal sex

    16-months

Secondary Outcomes (47)

  • Reduce alcohol/drug use

    baseline

  • Reduce instances of sexual activity

    baseline

  • Decrease the number of sexual partners

    baseline

  • Condom use during sexual activity

    baseline

  • Contraceptive use while sexually active

    baseline

  • +42 more secondary outcomes

Study Arms (2)

HIV, STI, and Pregnancy Prevention Curriculum

EXPERIMENTAL
Behavioral: HIV, STI and Pregnancy Prevention Curriculum

Control curricula: Science Education

ACTIVE COMPARATOR

No sexual health elements

Behavioral: Control Curricula

Interventions

HIV, STI and Pregnancy Prevention CurriculumBEHAVIORAL

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

HIV, STI, and Pregnancy Prevention Curriculum
Control CurriculaBEHAVIORAL

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

Control curricula: Science Education

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99508, United States

Location

Inter Tribal Council of Arizona, Inc.

Phoenix, Arizona, 85004, United States

Location

Northwest Portland Area Indian Health Board

Portland, Oregon, 97201, United States

Location

University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 27872037DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV InfectionsAcquired Immunodeficiency SyndromeChlamydia InfectionsGonorrhea

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesChlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialNeisseriaceae Infections

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • 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 (IHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - School of Public Health

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 24, 2011

Study Start

September 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 23, 2015

Record last verified: 2013-11

Locations

US(4)