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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00859144
First received: March 6, 2009
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Youth sexual risk behaviors [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth sexual risk behaviors [ Time Frame: Measured after 3 to 4 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth sexual risk behaviors [ Time Frame: Measured after 15 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • HIV educators' intentions to collaborate [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • HIV educators' intentions to collaborate [ Time Frame: Measured at post-intervention ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • HIV educators' intentions to collaborate [ Time Frame: Measured at 3-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • HIV educators' intentions to collaborate [ Time Frame: Measured at 15-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Collaboration by HIV educators [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Collaboration by HIV educators [ Time Frame: Measured at post-intervention ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Collaboration by HIV educators [ Time Frame: Measured at 3-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Collaboration by HIV educators [ Time Frame: Measured at 15-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Youth sexual behavior [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth sexual behavior [ Time Frame: Measured after 3 to 4 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth sexual behavior [ Time Frame: Measured after 15 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth negotiation of sexual risk situations [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth negotiation of sexual risk situations [ Time Frame: Measured after 3 to 4 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Youth negotiation of sexual risk situations [ Time Frame: Measured after 15 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months


Secondary Outcome Measures:
  • Leadership skills of HIV educators [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Leadership skills of HIV educators [ Time Frame: Measured at post-intervention ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Leadership skills of HIV educators [ Time Frame: Measured at 3-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Leadership skills of HIV educators [ Time Frame: Measured at 15-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured after 3 to 4 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured after 15 months ] [ Designated as safety issue: No ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  • Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at post-intervention ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at 3-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  • Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at 15-month follow-up ] [ Designated as safety issue: No ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups


Enrollment: 901
Study Start Date: March 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859144

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Mary M. McKay, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00859144     History of Changes
Other Study ID Numbers: GCO 03-0888, R01MH069934, DAHBR 9A-ASPA
Study First Received: March 6, 2009
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
HIV Prevention
Youth
Adolescent
Community Collaboration
Community Mentorship
Minority
Urban
Sexual Risk Behaviors
HIV seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014