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COMPLETED NA

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

NCT01303575 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 574 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 811 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01303575 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Alaska, Arizona, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01303575?

The interventions under investigation include: HIV, STI and Pregnancy Prevention Curriculum (BEHAVIORAL), Control Curricula (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01303575?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 811 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial