NCT00167505

Brief Summary

This study will evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that included abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. The second is a sexual risk reduction curriculum for middle school students that included abstinence and condom/contraceptive information and skills. Each intervention consists of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. The overall goal of the study is to identify common elements of effective sexuality education curricula that will be of benefit to youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,742

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 26, 2010

Status Verified

October 1, 2010

Enrollment Period

3.8 years

First QC Date

September 9, 2005

Last Update Submit

October 25, 2010

Conditions

Sexually Transmitted DiseasesPregnancyHIV Infections

Keywords

adolescentssexual healthHIVSTDpregnancy preventionabstinence educationHIV Seronegativityhuman immunodeficiency virus

Outcome Measures

Primary Outcomes (1)

  • delay onset of sex

    baseline, 6,18, 24, and 36 month follow-up

Secondary Outcomes (8)

  • knowledge

    baseline, 6,18, 24, and 36 month follow-up

  • skills

    baseline, 6, 18, 24, and 36 month follow-up

  • self-efficacy

    baseline, 6, 18, 24, and 36 month follow-up

  • attitudes

    baseline, 6, 18, 24, and 36 month follow-up

  • condom use

    baseline, 6, 18, 24, and 36 month follow-up

  • +3 more secondary outcomes

Study Arms (2)

Risk Avoidance

EXPERIMENTAL

The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Behavioral: Risk Avoidance Intervention

Risk Reduction

EXPERIMENTAL

The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Behavioral: Risk Reduction Intervention

Interventions

Risk Avoidance InterventionBEHAVIORAL

The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Risk Avoidance
Risk Reduction InterventionBEHAVIORAL

The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Risk Reduction

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th graders attending regular classes in Houston Independent School District

You may not qualify if:

  • No students will be excluded based on race/ethnicity, age, or gender
  • 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 (1)

University of Texas Houston School of Public Health

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV InfectionsAcquired Immunodeficiency Syndrome

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 Diseases

Study Officials

  • Christine Markham, PhD

    University of Texas Houston School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 26, 2010

Record last verified: 2010-10

Locations

US(1)