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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

March 6, 2009
March 7, 2012
March 2009
March 2012   (final data collection date for primary outcome measure)
  • 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
  • Youth sexual risk behaviors [ Time Frame: Measured at baseline, after 3 to 4 months, and after 15 months ] [ Designated as safety issue: No ]
  • HIV educators' intentions to collaborate [ Time Frame: Measured at baseline, post-intervention, and at 3- and 15-month follow-ups ] [ Designated as safety issue: No ]
  • Collaboration by HIV educators [ Time Frame: Measured at baseline, post-intervention, and at 3- and 15-month follow-ups ] [ Designated as safety issue: No ]
  • Youth sexual behavior [ Time Frame: Measured at baseline, after 3 to 4 months, and after 15 months ] [ Designated as safety issue: No ]
  • Youth negotiation of sexual risk situations [ Time Frame: Measured at baseline, after 3 to 4 months, and after 15 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00859144 on ClinicalTrials.gov Archive Site
  • 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
  • Leadership skills of HIV educators [ Time Frame: Measured at baseline, post-intervention, and at 3- and 15-month follow-ups ] [ Designated as safety issue: No ]
  • HIV/AIDS knowledge and attitudes of educators and youth [ Time Frame: Measured at baseline, after 3 to 4 months, and after 15 months ] [ Designated as safety issue: No ]
  • Self-esteem and self-efficacy of HIV educators [ Time Frame: Measured at baseline, post-intervention, and at 3- and 15-month follow-ups ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • HIV
  • HIV Infections
  • 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.
  • 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.
  • 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.
  • Experimental: BART
    Participants will complete the Becoming a Responsible Teen (BART) program.
    Intervention: Behavioral: Becoming A Responsible Teen (BART)
  • Experimental: Reducing the Risk
    Participants will complete the Reducing the Risk program.
    Intervention: Behavioral: Reducing the Risk
  • Active Comparator: Be Proud Be Responsible
    Participants will complete the Be Proud! Be Responsible! program.
    Intervention: Behavioral: Be Proud! Be Responsible!
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
901
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
12 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00859144
GCO 03-0888, R01MH069934, DAHBR 9A-ASPA
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Mary M. McKay, PhD Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP