Training Community Members to Deliver HIV Prevention Programs to Urban Youth

Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV
• Intervention / Treatment: Behavioral: Becoming A Responsible Teen (BART); Behavioral: Reducing the Risk; Behavioral: Be Proud! Be Responsible!

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 Type: Interventional
• Enrollment (Actual): 901
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Mary M. McKay, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 10, 2009

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Adolescent; HIV seronegativity; HIV Prevention; Minority; Youth; Urban; Community Collaboration; Community Mentorship; Sexual Risk Behaviors
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: GCO 03-0888; DAHBR 9A-ASPA (National Institute of Mental Health); R01MH069934 (U.S. NIH Grant/Contract)