Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223314
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-09-14
Brief Title:
Safer Choices 2 - HIV STD Pregnancy Prevention Program
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
HIV Prevention Among Alternative School Youth
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to adapt implement and evaluate an effective theoretically-based high school HIV prevention programSafer 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
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
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 HIVSTD 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 schoolsFurther 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 ie 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
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 HIVSTD 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 schoolsFurther 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None