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Safer Choices 2 - HIV, STD, & Pregnancy Prevention Program

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00223314
First received: September 14, 2005
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  Purpose

The purpose of the study is to adapt, implement, and evaluate an effective theoretically-based, high school HIV prevention program,Safer Choices, for higher risk youth in alternative schools.

Primary Research Question

1. Did the intervention reduce the number of occasions of unprotected sexual intercourse, number of sexual partners, and the proportion of students currently sexually active among those receiving the multiple component intervention relative to those students in the comparison group?


Condition Intervention
HIV
Sexually Transmitted Diseases
Pregnancy
HIV Infections
 Behavioral: HIV, STD, Pregnancy Prevention Curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention Among Alternative School Youth

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Among those reporting intercourse: # of occasions students had unprotected sexual intercourse and # of sexual partners with whom students had unprotected intercourse; proportion of students initiating sexual intercourse in the past 3 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol use behavior: frequency of drinking alcohol or being drunk before having sexual intercourse in the past three months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Drug use behavior: frequency of other drug use before having sex in the past three months. [ Time Frame: 24 moths ] [ Designated as safety issue: No ]
  • Drug use behavior: frequency of needle-sharing behavior during the past 12 months (one item). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of lifetime tests for HIV infection, [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of lifetime tests for STD infection other than HIV. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: November 2000
Study Completion Date: February 2004
Intervention Details:
    Behavioral: HIV, STD, Pregnancy Prevention Curriculum
    The curriculum is designed to change students' knowledge, perceptions of norms, beliefs, self-efficacy, interpersonal skills (i.e., refusal skills), and high-risk behaviors related to HIV. The curriculum included use of facilitators for selected lessons such as role playing. Intervention strategies included demonstrations of skills by role playing, use of role model stories, and other experiential learning techniques. The curriculum was delivered during the school days by facilitators (project staff) who received intensive training prior to implementation and coaching and support during implementation.
    Other Name: Safer Choices 2
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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 7th grade to 12 grade
  • Attend one of the ten recruited schools
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223314

Locations
United States, Texas
University of Texas Houston Health Science Center - School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Susan R Tortolero, PhD University of TExas Houston Health Science Center-School of Public Health
Study Director: Soledad L Escobar-Chaves, DrPH University of Texas Houston Health Science Center- School of Public Health
  More Information

Publications:

Responsible Party: Susan Tortolero/ Associate Professor and Director of the Center for Health Promotion & Prevention Research, University of Texas Houston School of Public Health
ClinicalTrials.gov Identifier: NCT00223314     History of Changes
Other Study ID Numbers: 1 R01 HD38457-01
Study First Received: September 14, 2005
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
HIV
Sexually Transmitted Diseases
Pregnancy
HIV Seronegativity

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 May 19, 2013