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Safer Choices 2 - HIV, STD, & Pregnancy Prevention Program
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
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
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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 Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | HIV Prevention Among Alternative School Youth |
Resource links provided by NLM:
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 ]
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 ]
- Drug use behavior: frequency of other drug use before having sex in the past three months. [ Time Frame: 24 moths ]
- Drug use behavior: frequency of needle-sharing behavior during the past 12 months (one item). [ Time Frame: 24 months ]
- Number of lifetime tests for HIV infection, [ Time Frame: 24 months ]
- Number of lifetime tests for STD infection other than HIV. [ Time Frame: 24 months ]
| 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
Show Detailed Description
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 7th grade to 12 grade
- Attend one of the ten recruited schools
Contacts and Locations
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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: NCT00223314
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: |
1R01HD038457-01 ( U.S. NIH Grant/Contract ) |
| Study First Received: | September 14, 2005 |
| Last Updated: | December 20, 2007 |
Keywords provided by The University of Texas Health Science Center, Houston:
|
HIV Sexually Transmitted Diseases Pregnancy HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 21, 2017