Training Community Members to Deliver HIV Prevention Programs to Urban Youth

HIV Infections Clinical Trial

Official title:

Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859144
• Other study ID #: GCO 03-0888
• Secondary ID: R01MH069934DAHBR
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2009
• Last updated: March 7, 2012
• Start date: March 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Youth sexual risk behaviors	Measured at baseline, after 3 to 4 months, and after 15 months	Measured at baseline	No
Primary	Youth sexual risk behaviors	Measured at baseline, after 3 to 4 months, and after 15 months	Measured after 3 to 4 months	No
Primary	Youth sexual risk behaviors	Measured at baseline, after 3 to 4 months, and after 15 months	Measured after 15 months	No
Primary	HIV educators' intentions to collaborate	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at baseline	No
Primary	HIV educators' intentions to collaborate	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at post-intervention	No
Primary	HIV educators' intentions to collaborate	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at 3-month follow-up	No
Primary	HIV educators' intentions to collaborate	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at 15-month follow-up	No
Primary	Collaboration by HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at baseline	No
Primary	Collaboration by HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at post-intervention	No
Primary	Collaboration by HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at 3-month follow-up	No
Primary	Collaboration by HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at 15-month follow-up	No
Primary	Youth sexual behavior	Measured at baseline, after 3 to 4 months, and after 15 months	Measured at baseline	No
Primary	Youth sexual behavior	Measured at baseline, after 3 to 4 months, and after 15 months	Measured after 3 to 4 months	No
Primary	Youth sexual behavior	Measured at baseline, after 3 to 4 months, and after 15 months	Measured after 15 months	No
Primary	Youth negotiation of sexual risk situations	Measured at baseline, after 3 to 4 months, and after 15 months	Measured at baseline	No
Primary	Youth negotiation of sexual risk situations	Measured at baseline, after 3 to 4 months, and after 15 months	Measured after 3 to 4 months	No
Primary	Youth negotiation of sexual risk situations	Measured at baseline, after 3 to 4 months, and after 15 months	Measured after 15 months	No
Secondary	Leadership skills of HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at baseline	No
Secondary	Leadership skills of HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at post-intervention	No
Secondary	Leadership skills of HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at 3-month follow-up	No
Secondary	Leadership skills of HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at 15-month follow-up	No
Secondary	HIV/AIDS knowledge and attitudes of educators and youth	Measured at baseline, after 3 to 4 months, and after 15 months	Measured at baseline	No
Secondary	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	No
Secondary	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	No
Secondary	Self-esteem and self-efficacy of HIV educators	Measured at baseline, post-intervention, and at 3- and 15-month follow-ups	Measured at baseline	No
Secondary	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	No
Secondary	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	No
Secondary	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	No