Training Community Members to Deliver HIV Prevention Programs to Urban Youth
Primary Purpose
HIV, HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Be Proud! Be Responsible!
Becoming A Responsible Teen (BART)
Reducing the Risk
Sponsored by
About this trial
This is an interventional prevention trial for HIV focused on measuring HIV Prevention, Youth, Adolescent, Community Collaboration, Community Mentorship, Minority, Urban, Sexual Risk Behaviors, HIV seronegativity
Eligibility Criteria
Inclusion Criteria
- Adult community HIV educators who are parents of a middle or high school aged child
- Adult participants must be between 25 and 60 years of age
- Youth participants must be between 12 and 15 years of age
- Residents of target communities in Bronx, NY
Exclusion Criteria:
- Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
- Significant cognitive impairment that might interfere with understanding of program content or informed consent process
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
BART
Reducing the Risk
Be Proud Be Responsible
Arm Description
Participants will complete the Becoming a Responsible Teen (BART) program.
Participants will complete the Reducing the Risk program.
Participants will complete the Be Proud! Be Responsible! program.
Outcomes
Primary Outcome Measures
Youth sexual risk behaviors
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual risk behaviors
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual risk behaviors
Measured at baseline, after 3 to 4 months, and after 15 months
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Youth sexual behavior
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual behavior
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual behavior
Measured at baseline, after 3 to 4 months, and after 15 months
Youth negotiation of sexual risk situations
Measured at baseline, after 3 to 4 months, and after 15 months
Youth negotiation of sexual risk situations
Measured at baseline, after 3 to 4 months, and after 15 months
Youth negotiation of sexual risk situations
Measured at baseline, after 3 to 4 months, and after 15 months
Secondary Outcome Measures
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV/AIDS knowledge and attitudes of educators and youth
Measured at baseline, after 3 to 4 months, and after 15 months
HIV/AIDS knowledge and attitudes of educators and youth
Measured at baseline, after 3 to 4 months, and after 15 months
HIV/AIDS knowledge and attitudes of educators and youth
Measured at baseline, after 3 to 4 months, and after 15 months
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Full Information
NCT ID
NCT00859144
First Posted
March 6, 2009
Last Updated
March 7, 2012
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00859144
Brief Title
Training Community Members to Deliver HIV Prevention Programs to Urban Youth
Official Title
Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.
Detailed Description
HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.
This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.
In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.
In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV Prevention, Youth, Adolescent, Community Collaboration, Community Mentorship, Minority, Urban, Sexual Risk Behaviors, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
901 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BART
Arm Type
Experimental
Arm Description
Participants will complete the Becoming a Responsible Teen (BART) program.
Arm Title
Reducing the Risk
Arm Type
Experimental
Arm Description
Participants will complete the Reducing the Risk program.
Arm Title
Be Proud Be Responsible
Arm Type
Active Comparator
Arm Description
Participants will complete the Be Proud! Be Responsible! program.
Intervention Type
Behavioral
Intervention Name(s)
Be Proud! Be Responsible!
Intervention Description
This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities. The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals.
Intervention Type
Behavioral
Intervention Name(s)
Becoming A Responsible Teen (BART)
Intervention Description
This program consists of highly structured modules administered using intervention manuals in community-based settings. Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice. Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management. Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability.
Intervention Type
Behavioral
Intervention Name(s)
Reducing the Risk
Intervention Description
This program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills. Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives.
Primary Outcome Measure Information:
Title
Youth sexual risk behaviors
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured at baseline
Title
Youth sexual risk behaviors
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 3 to 4 months
Title
Youth sexual risk behaviors
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 15 months
Title
HIV educators' intentions to collaborate
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at baseline
Title
HIV educators' intentions to collaborate
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at post-intervention
Title
HIV educators' intentions to collaborate
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 3-month follow-up
Title
HIV educators' intentions to collaborate
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 15-month follow-up
Title
Collaboration by HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at baseline
Title
Collaboration by HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at post-intervention
Title
Collaboration by HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 3-month follow-up
Title
Collaboration by HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 15-month follow-up
Title
Youth sexual behavior
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured at baseline
Title
Youth sexual behavior
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 3 to 4 months
Title
Youth sexual behavior
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 15 months
Title
Youth negotiation of sexual risk situations
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured at baseline
Title
Youth negotiation of sexual risk situations
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 3 to 4 months
Title
Youth negotiation of sexual risk situations
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 15 months
Secondary Outcome Measure Information:
Title
Leadership skills of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at baseline
Title
Leadership skills of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at post-intervention
Title
Leadership skills of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 3-month follow-up
Title
Leadership skills of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 15-month follow-up
Title
HIV/AIDS knowledge and attitudes of educators and youth
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured at baseline
Title
HIV/AIDS knowledge and attitudes of educators and youth
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 3 to 4 months
Title
HIV/AIDS knowledge and attitudes of educators and youth
Description
Measured at baseline, after 3 to 4 months, and after 15 months
Time Frame
Measured after 15 months
Title
Self-esteem and self-efficacy of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at baseline
Title
Self-esteem and self-efficacy of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at post-intervention
Title
Self-esteem and self-efficacy of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 3-month follow-up
Title
Self-esteem and self-efficacy of HIV educators
Description
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Time Frame
Measured at 15-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Adult community HIV educators who are parents of a middle or high school aged child
Adult participants must be between 25 and 60 years of age
Youth participants must be between 12 and 15 years of age
Residents of target communities in Bronx, NY
Exclusion Criteria:
Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
Significant cognitive impairment that might interfere with understanding of program content or informed consent process
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M. McKay, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Training Community Members to Deliver HIV Prevention Programs to Urban Youth
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