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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

7 mars 2012 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

901

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • New York, New York, États-Unis, 10029
        • Mount Sinai School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 60 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: BART
Participants will complete the Becoming a Responsible Teen (BART) program.
Comportemental: 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.
Expérimental: Reducing the Risk
Participants will complete the Reducing the Risk program.
Comportemental: 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.
Comparateur actif: Be Proud Be Responsible
Participants will complete the Be Proud! Be Responsible! program.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Youth sexual risk behaviors
Délai: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual risk behaviors
Délai: 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
Délai: 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
Délai: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
HIV educators' intentions to collaborate
Délai: 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
Délai: 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
Délai: 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
Délai: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Collaboration by HIV educators
Délai: 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
Délai: 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
Délai: 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
Délai: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual behavior
Délai: 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
Délai: 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
Délai: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth negotiation of sexual risk situations
Délai: 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
Délai: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Leadership skills of HIV educators
Délai: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Leadership skills of HIV educators
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Icahn School of Medicine at Mount Sinai

Collaborateurs

National Institute of Mental Health (NIMH)

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2009

Achèvement primaire (Réel)

1 mars 2012

Achèvement de l'étude (Réel)

1 mars 2012

Dates d'inscription aux études

Première soumission

6 mars 2009

Première soumission répondant aux critères de contrôle qualité

6 mars 2009

Première publication (Estimation)

10 mars 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 mars 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mars 2012

Dernière vérification

1 mars 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GCO 03-0888
  • DAHBR 9A-ASPA (National Institute of Mental Health)
  • R01MH069934 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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