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Effects of a Phone Call Intervention to Promote HAART Adherence (EPCIPHA)

15. juli 2011 opdateret af: Baoshan Prefecture Center for Disease Control and Prevention

Effects of a Phone Call Intervention to Promote HAART Adherence in Baoshan, China

The adherence rate (95%) to HAART in the intervention group which receives a phone call will be higher than that(75%)of control group which does not receive a phone call.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

According to above eligibility criteria, getting two eligible group patients, one which are patients newly required HAART (new cases) and the other who have received HAART for 1-3 years(old cases). All eligible patients in each group will be randomly assigned to intervention and control group by block randomization. Among of them, one group with a phone call intervention, the other without. New cases will be followed up for 3 months and study outcomes will be assessed at the baseline and the 2nd week, the 1st month and 2nd month, and the 3rd month. For the old cases, study outcomes will be assessed only at the baseline survey and at the 3rd month.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Yunnan
      • Baoshan, Yunnan, Kina, 67000
        • Rekruttering
        • Longling county hospital
        • Kontakt:
          • Chunyan Zhang, Bachelor
          • Telefonnummer: 86-0875-6122353
        • Ledende efterforsker:
          • Dongsheng Huang, Master
      • Baoshan, Yunnan, Kina, 678000
        • Rekruttering
        • Longyang district hospital
        • Ledende efterforsker:
          • Dongsheng Huang, Master
        • Kontakt:
      • Baoshan, Yunnan, Kina, 678000
        • Rekruttering
        • Tengchong county hospital
        • Ledende efterforsker:
          • Dongsheng Huang, Master
        • Kontakt:
          • Tao Jiang, Bachelor
          • Telefonnummer: 86-0875-5137151
          • E-mail: jt4766@sina.com
      • Baoshan, Yunnan, Kina, 67800
        • Rekruttering
        • The first hospital of Baoshan Prefecture
        • Ledende efterforsker:
          • Dongsheng Huang, Master
        • Kontakt:
          • Yikun Hu, Bachelor
          • Telefonnummer: 86-0875-2120370

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Chinese patients with HIV/AIDS aged ≥ 18 years and for the newly required HAART patients, mainly based on their CD4 < 350 cells/mm3. But irrespective of CD4 cells for old patients who are under treatment for 1-3 years.

Exclusion criteria:

  • Patients who have the inability to communicate at the beginning of study and who haven't got opportunistic infection(this item is only for new cases), who are non-Baoshan registered residence, who are foreigners, prisoners and pregnants, who have no mobile phone.

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: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phone call
New cases and old cases will be randomly categorized into two groups,respectively,one is phone call intervention group, the other is no phone call intervention group.
Adfærdsmæssigt: Phone call intervention, no phone call intervention
Biweekly phone call intervention +routine service will be assigned to intervention group of new cases and old cases. Only routine service will be assigned to the control group of abovementioned two kind of cases.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline HAART adherence within 3 months
Tidsramme: HAART adherence for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases HAART adherence will be assessed only at the baseline survey and the 3rd month follow-up
Adherence will be measured at different time points within 3 months follow-up (study period)
HAART adherence for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases HAART adherence will be assessed only at the baseline survey and the 3rd month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline quality of life within 3 months
Tidsramme: Quality of life for new cases will be assessed at the baseline survey and the 2nd week, the 1st month and 2nd month, and the 3rd month. For old cases quality of life will be assessed only at the baseline survey and the end of the 3rd month
Quality of life will be measured at different time points within 3 months study periods
Quality of life for new cases will be assessed at the baseline survey and the 2nd week, the 1st month and 2nd month, and the 3rd month. For old cases quality of life will be assessed only at the baseline survey and the end of the 3rd month
CD4 cell counts
Tidsramme: CD4 will be measured at the baseline survey and the 3rd month follow-up
CD4 cell counts will be measured only at baseline survey and after 3 months
CD4 will be measured at the baseline survey and the 3rd month follow-up
Number of patients with side effects
Tidsramme: Number of side effects for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases the number of side effects will be assessed only at the baseline survey and the 3rd month follow-up
The number of side effects will be measured at different time points within 3 months follow-up period
Number of side effects for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases the number of side effects will be assessed only at the baseline survey and the 3rd month follow-up
Number of opportunistic infection within 3 months
Tidsramme: Number of opportunistic infection for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases number of that will be assessed only at the baseline and the 3rd month follow-up
Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)
Number of opportunistic infection for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases number of that will be assessed only at the baseline and the 3rd month follow-up
Mortality
Tidsramme: Mortality will be assessed the 3rd month follow-up
Measurement of the number of change of mortality
Mortality will be assessed the 3rd month follow-up

Samarbejdspartnere og efterforskere

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

Sponsor

Baoshan Prefecture Center for Disease Control and Prevention

Samarbejdspartnere

Prince of Songkla University

Efterforskere

  • Studieleder: Weibing Zheng, Bachelor, Baoshan CDC

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 (Forventet)

1. september 2011

Studieafslutning (Forventet)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

18. juni 2011

Først indsendt, der opfyldte QC-kriterier

15. juli 2011

Først opslået (Skøn)

18. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BSCDC2011HIV/AIDS
  • BSWSJ2011HIV/AIDS (Andet bevillings-/finansieringsnummer: Grantor)

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