NCT00223314

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2000

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

September 14, 2005

Last Update Submit

December 20, 2007

Conditions

Keywords

HIVSexually Transmitted DiseasesPregnancyHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Secondary Outcomes (5)

  • Alcohol use behavior: frequency of drinking alcohol or being drunk before having sexual intercourse in the past three months.

    24 months

  • Drug use behavior: frequency of other drug use before having sex in the past three months.

    24 moths

  • Drug use behavior: frequency of needle-sharing behavior during the past 12 months (one item).

    24 months

  • Number of lifetime tests for HIV infection,

    24 months

  • Number of lifetime tests for STD infection other than HIV.

    24 months

Interventions

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.

Also known as: Safer Choices 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th grade to 12 grade
  • Attend one of the ten recruited schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

Related Publications (7)

  • 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. doi: 10.1111/j.1746-1561.2002.tb03559.x.

  • 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. doi: 10.2190/3J7L-YN0E-JAJ8-QC6P.

  • 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. doi: 10.1111/j.1746-1561.2003.tb03602.x.

  • 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. doi: 10.1080/02791072.2003.10400022.

  • 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. doi: 10.1177/1524839904266472.

  • 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. doi: 10.1363/psrh.35.174.03.

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV Infections

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Susan R Tortolero, PhD

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

    PRINCIPAL INVESTIGATOR
  • Soledad L Escobar-Chaves, DrPH

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

November 1, 2000

Study Completion

February 1, 2004

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations