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Training Community Members to Deliver HIV Prevention Programs to Urban Youth

7. mars 2012 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

901

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New York
      • New York, New York, Forente stater, 10029
        • Mount Sinai School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 60 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Eksperimentell: 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.
Aktiv 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Leadership skills of HIV educators
Tidsramme: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured at baseline
Leadership skills of HIV educators
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2009

Primær fullføring (Faktiske)

1. mars 2012

Studiet fullført (Faktiske)

1. mars 2012

Datoer for studieregistrering

Først innsendt

6. mars 2009

Først innsendt som oppfylte QC-kriteriene

6. mars 2009

Først lagt ut (Anslag)

10. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. mars 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mars 2012

Sist bekreftet

1. mars 2012

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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