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Completed

NCT Number: NCT00859144

Training Community Members to Deliver HIV Prevention Programs to Urban Youth

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Be Proud! Be Responsible!

Behavioral

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)

Behavioral

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

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 10, 2009
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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