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Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE PLUS

12. april 2012 opdateret af: Centers for Disease Control and Prevention

Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE Positives Leading and Utilizing Strategies (ADAPT CP PLUS)

This project will pilot test a step-by-step guide developed by CDC for organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The second purpose of the program is to evaluate the adapted intervention to determine if it is effective in changing behavior of HIV+ African American men who have sex with other men.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

During the ADAPT project both sites will adapt the original Community Promise intervention to specifically address the HIV prevention needs of sero-positive, African American men who have sex with men (HIV+ AAMSM) in either Boston, MA or Minneapolis/St. Paul (MSP), MN. The adapted intervention will be referred to as Community PROMISE, Positives Leading and Utilizing Strategies (CP PLUS).

In the first two months of the ADAPT project, the Boston and MSP sites will conduct formative evaluation activities (i.e., a comprehensive literature review, focus groups, and individual interviews) to assess the needs of the target population and organizational capacities to serve them. Results will be used to inform the adaptation of the original intervention to ensure that CP PLUS meet the expressed needs of the target population.

Process data will also be collected from various sources throughout the life of the project. Process data will be collected through staff meetings, interviews with staff, focus groups with peer advocates, and an expert panel consultation. Process data will be extremely useful for ensuring program objectives are met, improving CP PLUS, and providing information for providers in other locales who may be interested in adapting this intervention to serve this target population.

The Boston and MSP sites will also conduct outcome monitoring through collection of data concerning risk behaviors pre- and post-intervention implementation (follow-up at 6-8 months post and 11-13 months post [Boston only]) to determine if the adapted intervention has met its outcome objectives. Outcome monitoring will also be conducted for the "parent" intervention at both sites for HIV- or unknown status men who have sex with men.

In addition to the project activities, the organization will be examining the utility of the CDC draft guidance. The Boston and MSP sites are two of five case studies throughout the United States that will detail the challenges, successes and lessons learned from adapting an intervention packaged by CDC's Replicating Effective Programs (REP) and disseminated by Diffusing Effective Behavioral Interventions (DEBI) to a specific population. These findings will help other community-based organizations and Health Departments effectively adapt and tailor group, individual and community-level interventions.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

574

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • AIDS Action Committee
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Minneapolis Urban League

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

HIV+ cohort

  • Self-reports as HIV+ (for CP PLUS cohort)
  • Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
  • Self-reports as a resident of the identified geographic areas.
  • Identifies as African American
  • 18 years of age, or older.

HIV- cohort

  • HIV- or unknown status only, has engaged in risky sexual contact (defined as those who self-report engaging in unprotected anal or vaginal intercourse within the past year)
  • Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
  • Identifies as African American (MSP); No racial/ethnic criteria however AA will be over-sampled and will be at least 20% of sample
  • 18 years of age, or older.
  • Self-reports as a resident of the identified geographic areas.
  • Engage in risky sex (defined as individuals who self-report engaging in unprotected anal or vaginal intercourse within the past year.

Exclusion Criteria:

  • Inability to complete informed consent process due to (a) substantial cognitive impairment. (b) non-English speaking; (c) under the influence of drugs or alcohol
  • Under 18 years of age
  • Plans to relocate within 12 months after baseline interview
  • Anyone who does not meet inclusion criteria

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sexual activities with main and casual partners in past 30 days to 6 months (i.e., unprotected insertive and receptive anal/vaginal sex and protected insertive and receptive anal/vaginal sex)
Tidsramme: 7/2006-2/2007
7/2006-2/2007

Sekundære resultatmål

Resultatmål
Tidsramme
Behavioral intentions and attitudes for condom use; disclosure of HIV status; self reported STD diagnosis; medication adherence; links to care.
Tidsramme: 7/2006-2/2007
7/2006-2/2007

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Jennifer S Galbraith, Centers for Disease Control and Prevention

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2006

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)

1. februar 2007

Datoer for studieregistrering

Først indsendt

20. december 2005

Først indsendt, der opfyldte QC-kriterier

20. december 2005

Først opslået (Skøn)

21. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2012

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CDC-NCHSTP-U65/CCU523908
  • U65/CCU523908-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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