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:

MedlinePlus related topics: HIV/AIDS HIV/AIDS and Pregnancy Sexually Transmitted Diseases

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:

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


Ages Eligible for Study:	Child, Adult, Senior
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

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: 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:

Escobar-Chaves SL, Tortolero SR, Markham C, Kelder SH, Kapadia A. Violent behavior among urban youth attending alternative schools. J Sch Health. 2002 Nov;72(9):357-62.

Peters RJ Jr, Tortolero SR, Addy RC, Markham C, Escobar-Chaves SL, Fernandez-Esquer M, Yacoubian GS Jr. The relationship between sexual abuse and drug use: findings from Houston's Safer Choices 2 program. J Drug Educ. 2003;33(1):49-59.

Buzi RS, Tortolero SR, Roberts RE, Ross MW, Markham CM, Fleschler M. Gender differences in the consequences of a coercive sexual experience among adolescents attending alternative schools. J Sch Health. 2003 May;73(5):191-6.

Peters RJ Jr, Tortolero SR, Addy RC, Markham C, Yacoubian GS Jr, Escobar-Chaves LS. Drug use among Texas alternative school students: findings from Houston's Safer Choices 2 Program. J Psychoactive Drugs. 2003 Jul-Sep;35(3):383-7.

Buzi RS, Tortolero SR, Roberts RE, Ross MW, Addy RC, Markham CM. The impact of a history of sexual abuse on high-risk sexual behaviors among females attending alternative schools. Adolescence. 2003 Winter;38(152):595-605.

Tortolero SR, Markham CM, Parcel GS, Peters RJ Jr, Escobar-Chaves SL, Basen-Engquist K, Lewis HL. Using intervention mapping to adapt an effective HIV, sexually transmitted disease, and pregnancy prevention program for high-risk minority youth. Health Promot Pract. 2005 Jul;6(3):286-98.

Markham CM, Tortolero SR, Escobar-Chaves SL, Parcel GS, Harrist R, Addy RC. Family connectedness and sexual risk-taking among urban youth attending alternative high schools. Perspect Sex Reprod Health. 2003 Jul-Aug;35(4):174-9.


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
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 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 23, 2016

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