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Smoking Cessation for HIV/AIDS Patients

25. februar 2016 opdateret af: M.D. Anderson Cancer Center

An Innovative Telephone Intervention for HIV-Positive Smokers

The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.

Studieoversigt

Detaljeret beskrivelse

If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.

If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.

You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.

If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.

If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.

You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.

Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.

This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

706

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77009
        • Thomas Street Clinic

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

Alle

Beskrivelse

Inclusion Criteria:

  1. HIV-positive
  2. 18 years of age or older
  3. Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
  4. English or Spanish speaking
  5. Able to provide written informed consent to participate
  6. Willing to set a quit date within 1 week of baseline assessment

Exclusion Criteria:

  1. Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
  2. Current participation in another smoking cessation program

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Recommended Standard of Care
Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
Andre navne:
  • RSOC
Andet: RSOC + Cell Phone Intervention
Recommended Standard of Care (RSOC) + Cell Phone Intervention
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
Andre navne:
  • RSOC
Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.
Andre navne:
  • CPI

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
Tidsramme: 1 year after quit date
1 year after quit date

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Damon Vidrine, MS, DRPH, BA, M.D. Anderson Cancer Center

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.

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. januar 2004

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

16. juli 2007

Først indsendt, der opfyldte QC-kriterier

17. juli 2007

Først opslået (Skøn)

18. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. februar 2016

Sidst verificeret

1. februar 2016

Mere information

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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