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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

7. März 2012 aktualisiert von: Icahn School of Medicine at Mount Sinai

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

901

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Mount Sinai School of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 60 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: BART
Participants will complete the Becoming a Responsible Teen (BART) program.
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.
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.
Aktiver Komparator: Be Proud Be Responsible
Participants will complete the Be Proud! Be Responsible! program.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Youth sexual risk behaviors
Zeitfenster: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual risk behaviors
Zeitfenster: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
Youth sexual risk behaviors
Zeitfenster: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months
HIV educators' intentions to collaborate
Zeitfenster: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
HIV educators' intentions to collaborate
Zeitfenster: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
HIV educators' intentions to collaborate
Zeitfenster: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
HIV educators' intentions to collaborate
Zeitfenster: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up
Collaboration by HIV educators
Zeitfenster: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Collaboration by HIV educators
Zeitfenster: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
Collaboration by HIV educators
Zeitfenster: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
Collaboration by HIV educators
Zeitfenster: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up
Youth sexual behavior
Zeitfenster: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual behavior
Zeitfenster: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
Youth sexual behavior
Zeitfenster: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months
Youth negotiation of sexual risk situations
Zeitfenster: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth negotiation of sexual risk situations
Zeitfenster: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
Youth negotiation of sexual risk situations
Zeitfenster: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Leadership skills of HIV educators
Zeitfenster: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Leadership skills of HIV educators
Zeitfenster: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
Leadership skills of HIV educators
Zeitfenster: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
Leadership skills of HIV educators
Zeitfenster: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up
HIV/AIDS knowledge and attitudes of educators and youth
Zeitfenster: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
HIV/AIDS knowledge and attitudes of educators and youth
Zeitfenster: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 3 to 4 months
HIV/AIDS knowledge and attitudes of educators and youth
Zeitfenster: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months
Self-esteem and self-efficacy of HIV educators
Zeitfenster: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Self-esteem and self-efficacy of HIV educators
Zeitfenster: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at post-intervention
Self-esteem and self-efficacy of HIV educators
Zeitfenster: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 3-month follow-up
Self-esteem and self-efficacy of HIV educators
Zeitfenster: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at 15-month follow-up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Mary M. McKay, PhD, Icahn School of Medicine at Mount Sinai

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2009

Primärer Abschluss (Tatsächlich)

1. März 2012

Studienabschluss (Tatsächlich)

1. März 2012

Studienanmeldedaten

Zuerst eingereicht

6. März 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. März 2009

Zuerst gepostet (Schätzen)

10. März 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

8. März 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. März 2012

Zuletzt verifiziert

1. März 2012

Mehr Informationen

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