HIV, STD, Pregnancy Prevention Curriculum in HIV Infections and Sexually Transmitted Diseases and Pregnancy - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: HIV, STD, Pregnancy Prevention Curriculum

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:

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.
Assess the community acceptance, cultural sensitivity, and relevance of the proposed program for the target population.
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.
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.
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.
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.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Houston, Texas, United States, 77030
    - University of Texas Houston Health Science Center - School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

7th grade to 12 grade
Attend one of the ten recruited schools

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Alcohol use behavior: frequency of drinking alcohol or being drunk before having sexual intercourse in the past three months. Time Frame: 24 months	24 months
Drug use behavior: frequency of other drug use before having sex in the past three months. Time Frame: 24 moths	24 moths
Drug use behavior: frequency of needle-sharing behavior during the past 12 months (one item). Time Frame: 24 months	24 months
Number of lifetime tests for HIV infection, Time Frame: 24 months	24 months
Number of lifetime tests for STD infection other than HIV. Time Frame: 24 months	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion (ACTUAL)

February 1, 2004

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria