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Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting

1. august 2019 opdateret af: Peter Monti, Brown University
This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Fenway Health

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

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • be at least 18 years of age
  • drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week
  • have a confirmed diagnosis of HIV/AIDS
  • be a male who has had sex (oral or anal) with a male partner in the past 3 months.

Exclusion Criteria:

  • current intravenous drug use
  • currently psychotic, suicidal, or manic
  • are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection
  • currently receiving treatment for an alcohol or drug problem

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Treatment as usual
Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.
Eksperimentel: Brief Alcohol Intervention
Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls
Adfærdsmæssigt: Brief alcohol intervention
3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Alcoholic Drinks Consumed
Tidsramme: 12 months
Number of standard alcoholic drinks consumed per week in the past month
12 months
Number of Heavy Drinking Days
Tidsramme: 12 months
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
12 months
Number of Heavy Drinking Days
Tidsramme: 6 months
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
6 months
Number of Heavy Drinking Days
Tidsramme: 3 months
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
3 months
Number of Alcoholic Drinks Consumed
Tidsramme: 3 months
Number of standard alcoholic drinks consumed per week in the past month
3 months
Number of Alcoholic Drinks Consumed
Tidsramme: 6 months
Number of standard alcoholic drinks consumed per week in the past month
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Brown University

Efterforskere

  • Ledende efterforsker: Peter Monti, Ph.D., Brown University
  • Studieleder: Christopher Kahler, Ph.D., Brown University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2011

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

31. marts 2011

Først indsendt, der opfyldte QC-kriterier

4. april 2011

Først opslået (Skøn)

5. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NIAAA-P01-AA019072-1

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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Betingelser

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Placeringer

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