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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

7 maart 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

901

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10029
        • Mount Sinai School of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 60 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BART
Participants will complete the Becoming a Responsible Teen (BART) program.
Gedragsmatig: 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.
Experimenteel: Reducing the Risk
Participants will complete the Reducing the Risk program.
Gedragsmatig: 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.
Actieve vergelijker: Be Proud Be Responsible
Participants will complete the Be Proud! Be Responsible! program.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Youth sexual risk behaviors
Tijdsspanne: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual risk behaviors
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
HIV educators' intentions to collaborate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Collaboration by HIV educators
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth sexual behavior
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Measured at baseline
Youth negotiation of sexual risk situations
Tijdsspanne: 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
Tijdsspanne: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Measured after 15 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Leadership skills of HIV educators
Tijdsspanne: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Leadership skills of HIV educators
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Icahn School of Medicine at Mount Sinai

Medewerkers

National Institute of Mental Health (NIMH)

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2009

Primaire voltooiing (Werkelijk)

1 maart 2012

Studie voltooiing (Werkelijk)

1 maart 2012

Studieregistratiedata

Eerst ingediend

6 maart 2009

Eerst ingediend dat voldeed aan de QC-criteria

6 maart 2009

Eerst geplaatst (Schatting)

10 maart 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

8 maart 2012

Laatste update ingediend die voldeed aan QC-criteria

7 maart 2012

Laatst geverifieerd

1 maart 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GCO 03-0888
  • DAHBR 9A-ASPA (National Institute of Mental Health)
  • R01MH069934 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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