Training Community Members to Deliver HIV Prevention Programs to Urban Youth

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00859144

Collaborator

National Institute of Mental Health (NIMH) (NIH)

901

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV HIV Infections	Behavioral: Be Proud! Be Responsible! Behavioral: Becoming A Responsible Teen (BART) Behavioral: Reducing the Risk	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

901 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BART Participants will complete the Becoming a Responsible Teen (BART) program.	Behavioral: Becoming A Responsible Teen (BART) 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.
Experimental: Reducing the Risk Participants will complete the Reducing the Risk program.	Behavioral: Reducing the Risk 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.
Active Comparator: Be Proud Be Responsible Participants will complete the Be Proud! Be Responsible! program.	Behavioral: Be Proud! Be Responsible! 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.

Arm

Intervention/Treatment

Experimental: BART

Participants will complete the Becoming a Responsible Teen (BART) program.

Behavioral: Becoming A Responsible Teen (BART)

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.

Experimental: Reducing the Risk

Participants will complete the Reducing the Risk program.

Behavioral: Reducing the Risk

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.

Active Comparator: Be Proud Be Responsible

Participants will complete the Be Proud! Be Responsible! program.

Behavioral: Be Proud! Be Responsible!

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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