Training Community Members to Deliver HIV Prevention Programs to Urban Youth

Phase 3

Completed

• Conditions: HIV; HIV Infections
• Interventions: Behavioral: Reducing the Risk; Behavioral: Becoming A Responsible Teen (BART); Behavioral: Be Proud! Be Responsible!

• Registration Number: NCT00859144
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-10
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 901

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reducing the Risk	Reducing the Risk	Participants will complete the Reducing the Risk program.
BART	Becoming A Responsible Teen (BART)	Participants will complete the Becoming a Responsible Teen (BART) program.
Be Proud Be Responsible	Be Proud! Be Responsible!	Participants will complete the Be Proud! Be Responsible! program.

Primary Outcome Measures

Name	Time	Method
Collaboration by HIV educators	Measured at 15-month follow-up	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Youth negotiation of sexual risk situations	Measured after 15 months	Measured at baseline, after 3 to 4 months, and after 15 months
HIV educators' intentions to collaborate	Measured at 15-month follow-up	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Youth sexual risk behaviors	Measured after 15 months	Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual behavior	Measured after 15 months	Measured at baseline, after 3 to 4 months, and after 15 months

Secondary Outcome Measures

Name	Time	Method
HIV/AIDS knowledge and attitudes of educators and youth	Measured after 15 months	Measured at baseline, after 3 to 4 months, and after 15 months
Leadership skills of HIV educators	Measured at 15-month follow-up	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Self-esteem and self-efficacy of HIV educators	Measured at 15-month follow-up	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States