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NCT01303575 · ClinicalTrials.gov registry record · NA

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

A NA study of HIV Infections and Pregnancy, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
NA
Development phase
574
Enrollment target
4
Study locations

NCT01303575 is a NA study of HIV Infections and Pregnancy that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 574 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (29% higher). The trial reports 4 study locations across 4 states.

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The verdict

NCT01303575, a NA study of HIV Infections and Pregnancy, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
NA
Development phase
574 participants
Enrollment target
4
Study locations

Study 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.

Conditions Studied

HIV Infections Pregnancy Sexually Transmitted Diseases

Interventions

  • BEHAVIORAL HIV, STI and Pregnancy Prevention Curriculum
  • BEHAVIORAL Control Curricula

Study Locations (4)

Alaska

  • Alaska Native Tribal Health Consortium - Anchorage

Arizona

  • Inter Tribal Council of Arizona, Inc. - Phoenix

Oregon

  • Northwest Portland Area Indian Health Board - Portland

Texas

  • University of Texas Health Science Center, Houston - Houston

Trial Details

FieldValue
Enrollment Target 574 participants
Start Date 2010-09
Est. Completion 2015-01
Phase NA

Sponsor

The University of Texas Health Science Center, Houston

732 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01303575

The ClinicalTrials.gov registry entry for NCT01303575 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 574 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (29% higher). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which HIV, STI and Pregnancy Prevention Curriculum is the first listed.

NCT01303575 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Alaska, Arizona, Oregon.

Frequently Asked Questions

What is clinical trial NCT01303575 about?

NCT01303575 is a clinical study titled "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 I...

What is the current status of trial NCT01303575?

This trial is currently completed. It is a NA study. The enrollment target is 574 participants. The study started on 2010-09. Estimated completion is 2015-01.

What conditions does trial NCT01303575 study?

This clinical trial studies the following conditions: HIV Infections, Pregnancy, Sexually Transmitted Diseases.

What interventions are being tested in trial NCT01303575?

The interventions under investigation include: HIV, STI and Pregnancy Prevention Curriculum (BEHAVIORAL), Control Curricula (BEHAVIORAL).

Who is sponsoring clinical trial NCT01303575?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01303575 being conducted?

This trial has 4 study locations across Alaska, Arizona, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.