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

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
  Hide Detailed Description

Detailed Description:

This is a group-randomized intervention trial to reduce sexual risk-taking behaviors among young people attending alternative schools with a slight modification in the typical, group-randomized study design.

We will conduct the study in two waves. For Wave One, we will randomize 10 alternative schools (5 to intervention and 5 to comparison conditions), and then recruit and enroll a cohort of 500, 9th-grade students into the study (cohort 1). For Wave Two, we will cross-over the treatment conditions among the schools and enroll a new cohort of 9th-grade students into the study. Prior to the intervention, we will conduct a baseline measurement and conduct a post-intervention measurement at 6-, 12- and 24-months. The major hypothesis to be tested is that adolescents attending alternative schools who receive a multi-component HIV/STD intervention will reduce levels of unprotected sexual intercourse relative to those in the comparison condition. The major dependent variables are unprotected sexual intercourse, number of sexual partners, and proportion currently sexually active (last 3 months).

The specific aims of this project are to:

  1. Adapt a tested, school-based, multi-component HIV prevention intervention for high-risk adolescents attending alternative schools using qualitative data from the target population and community representatives.
  2. Assess the community acceptance, cultural sensitivity, and relevance of the proposed program for the target population.
  3. Evaluate the effect of the multi-component HIV intervention on sexual risk-taking behaviors (unprotected sexual intercourse, number of sexual partners, deciding not to have sexual intercourse) among high-risk youth attending alternative schools.
  4. Evaluate the effect of the multi-component HIV intervention on decreasing other risk-taking behaviors such as substance use and needle sharing behavior among youth attending alternative schools.
  5. Evaluate the effect of the multi-component HIV intervention on student impact variables such as knowledge, self efficacy, attitudes, barriers, and perceived norms among youth attending alternative schools.
  6. Disseminate findings to the scientific community, school districts, and community agencies.

We will conduct this study among 9th- grade students attending alternative schools in Houston Independent School District (HISD) and other community alternative schools. HISD Central Administration and Community Education Partners, the major HISD contractor, for alternative schools have agreed to participate in the study. We have identified ten alternative schools that have agreed to participate in the study. Students who are enrolled in alternative schools are fairly heterogeneous in terms of the rationale for being in these types of programs. Students may be in these programs for a variety of reasons including, low school performance, high absenteeism, truancy, behavior problems, social problems, pregnancy, or being in the juvenile justice system. However, all of the students enrolled in the identified schools are considered high-risk adolescents. We have identified 10 schools that have agreed to participate in the study with a total number of students enrolled in 9th grade at over 1000 students per year providing a more than adequate target population for recruitment. Of these students, 36% are African-American and 60% are Hispanic. Approximately 43% of the population are female.

Parental and student consent will be secured prior to administration of the risk assessment. Procedures will be used to achieve high rates of parental consent including sending information home about the project with particular emphasis on the confidential nature of the risk assessment.

Risk assessment data will be collected by using a talking, interactive computer for the collection of baseline, 6-month, 12-month, and 24-month post-intervention followup.

Baseline data collection will be conducted in the schools. The data collection staff will give a brief overview of how to use the computer and will help them to enter basic demographic information to acquaint them with the procedures. The computer will be equipped with headphones to maintain privacy, and the respondent can ask questions to our data collection staff, if needed. Post-intervention risk assessments will be conducted in the schools as youth are still enrolled in the alternative school program. We expect that the majority of students will still be enrolled in the alternative school at the 6-month followup, but that the 12-month and 24-month follow up will have to be conducted in various locations. We will track students enrolled in the study and conduct their follow up assessments in school, home, or in a location that is mutually agreed upon.

Curriculum Component We will adapt an existing curriculum, Safer Choices, to high-risk alternative school youth by obtaining feedback from the target population, conducting focus groups with parents and youths, and by obtaining feedback from community agencies through the Community Advisory Board. Although, Safer Choices was found to be effective in reducing unprotected sexual intercourse among inner-city high school students in Houston, the curriculum may need to be adapted to the experiences of these alternative school youth.

The target population has much higher prevalence of risk behaviors at younger ages than adolescents in regular schools.Further, these youth are at much greater risk of abusing drugs, being involved with legal authorities, being from single family households, having lower social support, having academic difficulties and learning disabilities, having suicide ideation and depression, and living in poorer communities. In adapting the program, therefore, we face the challenge of making the program fit the setting and students in alternative schools.

The curriculum will be 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 will include use of peer facilitators for selected lessons such as role playing. Intervention strategies will include demonstrations of skills by role playing, use of role model stories, and other experiential learning techniques. The Safer Choices curriculum will be modified to combine the 9th and 10th grade lessons to select those lessons which best match with the learning objectives for high-risk youth. The curriculum will be delivered during the school days by facilitators (project staff) who will receive intensive training prior to implementation and coaching and support during implementation. The Teacher Training Protocol used for Safer Choices will be adapted to train facilitators.

  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
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
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 September 18, 2014