All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00167505
First received: September 9, 2005
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Sexually Transmitted Diseases
Pregnancy
HIV Infections
Behavioral: Risk Avoidance Intervention
Behavioral: Risk Reduction Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SIP 4-04 Evaluation of Abstinence-Only and Abstinence-Plus Program to Prevent HIV, STD, and Pregnancy Among Middle School Students

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • delay onset of sex [ Time Frame: baseline, 6,18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • knowledge [ Time Frame: baseline, 6,18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • skills [ Time Frame: baseline, 6, 18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • self-efficacy [ Time Frame: baseline, 6, 18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • attitudes [ Time Frame: baseline, 6, 18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • condom use [ Time Frame: baseline, 6, 18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • alcohol/drug use [ Time Frame: baseline, 6, 18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • number of sexual partners [ Time Frame: baseline, 6, 18, 24, and 36 month follow-up ] [ Designated as safety issue: No ]
  • prevalence of chlamydia, gonorrhea, and trichomonas [ Time Frame: 36-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 1742
Study Start Date: September 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risk Avoidance
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
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.
Experimental: Risk Reduction
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
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.

Detailed Description:

This study will evaluate the efficacy of a risk avoidance program for middle school students and a theoretically-comparable risk reduction program relative to standard care. The study design is a randomized controlled trial conducted in fifteen inner-city middle schools in Houston, Texas. Five schools were randomly assigned to a risk avoidance intervention, five to a risk reduction intervention, and five to a comparison (standard care) condition. Approximately, 1,800 7th grade students were recruited into the study and will be followed over a three-year period. Based on a formative study, a pilot study, and input from community groups and a national panel of experts, two comparable curricula were developed. The risk avoidance curriculum emphasizes sexual abstinence until marriage and includes the requirements for abstinence education as defined in Title V, Section 510. The risk reduction curriculum emphasizes abstinence and addresses condom and contraceptive use. The risk avoidance and risk reduction interventions each consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. Each intervention was delivered by trained facilitators. The effect of the interventions will be evaluated by assessing sexual risk-taking behaviors of participants in each intervention (proportion of students initiating sexual intercourse, proportion that are sexually active, number of times of unprotected sex, number of sexual partners) relative to the comparison group. Risk assessment data from students was collected by using an audio computer-assisted self-interview (ACASI) approach for the collection of baseline, 6-, 18-, and 24-month data. Parental permission and child assent were required prior to participation. In addition, we will conduct a 36-month follow-up survey and a one-time urine-based test for chlamydia, gonorrhea, and trichomonas which will provide additional longitudinal data to assess the impact of each curriculum, relative to standard care.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 7th graders attending regular classes in Houston Independent School District

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167505

Locations
United States, Texas
University of Texas Houston School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Christine Markham, PhD University of Texas Houston School of Public Health
  More Information

No publications provided

Responsible Party: Christine Markham, PhD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00167505     History of Changes
Obsolete Identifiers: NCT00207545
Other Study ID Numbers: U48/DP000057
Study First Received: September 9, 2005
Last Updated: October 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
adolescents
sexual health
HIV
STD
pregnancy prevention
abstinence education
HIV Seronegativity
human immunodeficiency virus

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014