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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

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ClinicalTrials.gov Identifier: NCT00859144
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : March 8, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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Study Type : Interventional  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Youth sexual risk behaviors [ Time Frame: Measured at baseline ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  2. Youth sexual risk behaviors [ Time Frame: Measured after 3 to 4 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  3. Youth sexual risk behaviors [ Time Frame: Measured after 15 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  4. HIV educators' intentions to collaborate [ Time Frame: Measured at baseline ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  5. HIV educators' intentions to collaborate [ Time Frame: Measured at post-intervention ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  6. HIV educators' intentions to collaborate [ Time Frame: Measured at 3-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  7. HIV educators' intentions to collaborate [ Time Frame: Measured at 15-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  8. Collaboration by HIV educators [ Time Frame: Measured at baseline ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  9. Collaboration by HIV educators [ Time Frame: Measured at post-intervention ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  10. Collaboration by HIV educators [ Time Frame: Measured at 3-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  11. Collaboration by HIV educators [ Time Frame: Measured at 15-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  12. Youth sexual behavior [ Time Frame: Measured at baseline ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  13. Youth sexual behavior [ Time Frame: Measured after 3 to 4 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  14. Youth sexual behavior [ Time Frame: Measured after 15 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  15. Youth negotiation of sexual risk situations [ Time Frame: Measured at baseline ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  16. Youth negotiation of sexual risk situations [ Time Frame: Measured after 3 to 4 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  17. Youth negotiation of sexual risk situations [ Time Frame: Measured after 15 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months


Secondary Outcome Measures :
  1. Leadership skills of HIV educators [ Time Frame: Measured at baseline ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  2. Leadership skills of HIV educators [ Time Frame: Measured at post-intervention ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  3. Leadership skills of HIV educators [ Time Frame: Measured at 3-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  4. Leadership skills of HIV educators [ Time Frame: Measured at 15-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  5. HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured at baseline ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  6. HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured after 3 to 4 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  7. HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured after 15 months ]
    Measured at baseline, after 3 to 4 months, and after 15 months

  8. Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at baseline ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  9. Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at post-intervention ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  10. Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at 3-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  11. Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at 15-month follow-up ]
    Measured at baseline, post-intervention, and at 3- and 15-month follow-ups


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859144


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Mary M. McKay, PhD Icahn School of Medicine at Mount Sinai
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00859144     History of Changes
Other Study ID Numbers: GCO 03-0888
R01MH069934 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASPA
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

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

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