Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students

NCT00161382 | Completed Results

• 2 other identifiers: R01MH066640R01MH066640-01
• Study Type: interventional
• Target: 3,007
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

Conditions

HIV Infections; Sexually Transmitted Diseases; Pregnancy

Keywords

HIV Seronegativity; HIV

Outcome Measures

Primary Outcomes (1)

• Initiation of Sexual Intercourse

  The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.

  Measured throughout the study, and at 2006/2007 school year

Secondary Outcomes (7)

• Knowledge

  Measured throughout the study

• Self-efficacy

  Measured throughout the study

• Attitudes

  Measured throughout the study

• Perceived Norms

  Measured throughout the study

• Barriers

  Measured throughout the study

Study Arms (2)

Intervention Group

EXPERIMENTAL

HIV, STD, and pregnancy prevention curriculum

Behavioral: HIV, STD, and pregnancy prevention curriculum

Control Group

EXPERIMENTAL

Standard sexual education curriculum

Behavioral: Standard sexual education curriculum

Interventions

HIV, STD, and pregnancy prevention curriculum BEHAVIORAL

This HIV, STD, and pregnancy intervention program entitled, "It's Your Game...Keep it Real", consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits.

Intervention Group

Standard sexual education curriculum BEHAVIORAL

Control curriculum consists of standard sexual education.

Control Group

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• th Grade
• Attend one of the ten recruited schools

You may not qualify if:

• Non-English speaking
• Physical disability that prevents student from completing intervention and survey

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Texas Houston Health Science Center - School of Public Health

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Tortolero SR, Markham CM, Peskin MF, Shegog R, Addy RC, Escobar-Chaves SL, Baumler ER. It's Your Game: Keep It Real: delaying sexual behavior with an effective middle school program. J Adolesc Health. 2010 Feb;46(2):169-79. doi: 10.1016/j.jadohealth.2009.06.008. Epub 2009 Aug 18.

  PMID: 20113923 RESULT

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Results Point of Contact

• Title: Dr. Susan R. Tortolero
• Organization: The University of Texas Health Science Center at Houston (UTHealth) School of Public Health

Susan.Tortolero@uth.tmc.edu

713-500-9634

Study Officials

• Susan R. Tortolero, PhD

  University of Texas Houston Health Science Center - School of Public Health

  PRINCIPAL INVESTIGATOR

• Christine M. Markham, PhD

  University of Texas Houston Health Science Center - School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: ◦Allan King Professorship in Public Health & Director, Center for Health Promotion and Prevention Research

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: July 1, 2008
• Last Updated: July 8, 2014
• Results First Posted: June 24, 2014

Record last verified: 2014-06

Locations

US (1)