Clinical trial NCT00859144: Training Community Members to Deliver HIV Prevention Programs to Urban Youth
Official title: Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
HIV Infections
Keywords: HIV Prevention
Youth
Adolescent
Community Collaboration
Community Mentorship
Minority
Urban
Sexual Risk Behaviors
HIV seronegativity
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-03-10
Enrollment: 901
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Youth sexual risk behaviors
timeFrame: Measured at baseline
measure: Youth sexual risk behaviors
timeFrame: Measured after 3 to 4 months
measure: Youth sexual risk behaviors
timeFrame: Measured after 15 months
measure: HIV educators' intentions to collaborate
timeFrame: Measured at baseline
measure: HIV educators' intentions to collaborate
timeFrame: Measured at post-intervention
measure: HIV educators' intentions to collaborate
timeFrame: Measured at 3-month follow-up
measure: HIV educators' intentions to collaborate
timeFrame: Measured at 15-month follow-up
measure: Collaboration by HIV educators
timeFrame: Measured at baseline
measure: Collaboration by HIV educators
timeFrame: Measured at post-intervention
measure: Collaboration by HIV educators
timeFrame: Measured at 3-month follow-up
measure: Collaboration by HIV educators
timeFrame: Measured at 15-month follow-up
measure: Youth sexual behavior
timeFrame: Measured at baseline
measure: Youth sexual behavior
timeFrame: Measured after 3 to 4 months
measure: Youth sexual behavior
timeFrame: Measured after 15 months
measure: Youth negotiation of sexual risk situations
timeFrame: Measured at baseline
measure: Youth negotiation of sexual risk situations
timeFrame: Measured after 3 to 4 months
measure: Youth negotiation of sexual risk situations
timeFrame: Measured after 15 months
Secondary outcomes:
measure: Leadership skills of HIV educators
timeFrame: Measured at baseline
measure: Leadership skills of HIV educators
timeFrame: Measured at post-intervention
measure: Leadership skills of HIV educators
timeFrame: Measured at 3-month follow-up
measure: Leadership skills of HIV educators
timeFrame: Measured at 15-month follow-up
measure: HIV/AIDS knowledge and attitudes of educators and youth
timeFrame: Measured at baseline
measure: HIV/AIDS knowledge and attitudes of educators and youth
timeFrame: Measured after 3 to 4 months
measure: HIV/AIDS knowledge and attitudes of educators and youth
timeFrame: Measured after 15 months
measure: Self-esteem and self-efficacy of HIV educators
timeFrame: Measured at baseline
measure: Self-esteem and self-efficacy of HIV educators
timeFrame: Measured at post-intervention
measure: Self-esteem and self-efficacy of HIV educators
timeFrame: Measured at 3-month follow-up
measure: Self-esteem and self-efficacy of HIV educators
timeFrame: Measured at 15-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mary M. McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: