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Ensayos clínicos

Ensayos clínicos

Durability of Adherence in Self-Management of HIV (The DASH Study)

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00991302, ACTG A5250
  • Inscripciones abiertas

Propósito del estudio

Adherence to highly active antiretroviral therapy (HAART) is critical to successful treatment of HIV. This study will test an intervention that helps people infected with HIV take all their medications when and how they are supposed to.

Afección:Fase:
Infecciones por el VIH
Fase 3

Detalles del estudio

People infected with HIV must take the regimen of highly active antiretroviral therapy

(HAART) medications as prescribed to them, without missing doses, or they risk developing a

resistant strain of the virus. Resistant strains of the virus do not respond to certain

HAART regimens and are more dangerous for patients. Poor HAART adherence can lead to further

HIV progression, more hospitalizations and opportunistic infections, and required use of

second-line therapies. Interventions to increase adherence have had mixed success, with

little data to support long-term effects and no one strategy emerging that provides

consistent positive effects. The client adherence profiling and intervention tailoring

(CAP-IT) program was first developed to increase adherence among people already on HAART

with in-home nursing. This study will modify CAP-IT to treat people newly on HAART and then

test whether this modified CAP-IT improves long-term HAART adherence.



This study will include two stages. The first stage consists of two focus groups, one made

up of HIV care providers and professionals and the other made up of people infected with HIV

who have started HAART within the last year. Each focus group will meet once, for

approximately 2 hours, to determine what modifications would best adapt the CAP-IT program

to HIV-infected people first starting HAART.



The second stage consists of a randomized trial comparing the modified CAP-IT program to

standard of care. Participation in this stage will last for 72 weeks. Participants will be

randomly assigned to receive either standard care or the modified CAP-IT program with

standard care. The CAP-IT program involves two steps. The first is an assessment of factors

relating to adherence, and the second is development of an individualized plan to address

the deficits found.



Study visits will be completed at entry, at Weeks 4 and 12, and then every 12 weeks for

approximately 72 weeks. Assessments for the study will include a questionnaire about health

attitudes, a physical exam, counting of pills, and answering questions about taking

medications. Blood draws will also occur at Weeks 4, 24, and 48.People infected with HIV must take the regimen of highly active antiretroviral therapy

(HAART) medications as prescribed to them, without missing doses, or they risk developing a

resistant strain of the virus. Resistant strains of the virus do not respond to certain

HAART regimens and are more dangerous for patients. Poor HAART adherence can lead to further

HIV progression, more hospitalizations and opportunistic infections, and required use of

second-line therapies. Interventions to increase adherence have had mixed success, with

little data to support long-term effects and no one strategy emerging that provides

consistent positive effects. The client adherence profiling and intervention tailoring

(CAP-IT) program was first developed to increase adherence among people already on HAART

with in-home nursing. This study will modify CAP-IT to treat people newly on HAART and then

test whether this modified CAP-IT improves long-term HAART adherence.



This study will include two stages. The first stage consists of two focus groups, one made

up of HIV care providers and professionals and the other made up of people infected with HIV

who have started HAART within the last year. Each focus group will meet once, for

approximately 2 hours, to determine what modifications would best adapt the CAP-IT program

to HIV-infected people first starting HAART.



The second stage consists of a randomized trial comparing the modified CAP-IT program to

standard of care. Participation in this stage will last for 72 weeks. Participants will be

randomly assigned to receive either standard care or the modified CAP-IT program with

standard care. The CAP-IT program involves two steps. The first is an assessment of factors

relating to adherence, and the second is development of an individualized plan to address

the deficits found.



Study visits will be completed at entry, at Weeks 4 and 12, and then every 12 weeks for

approximately 72 weeks. Assessments for the study will include a questionnaire about health

attitudes, a physical exam, counting of pills, and answering questions about taking

medications. Blood draws will also occur at Weeks 4, 24, and 48.

Criterios de inclusión

    for Stage 1 for HIV infected Individuals on Highly Active Antiretroviral Therapy (HAART):
    • HIV-1 infection
    • Initiated HAART within 1 year prior to study entry
    • Men and women who have reached the legal age of majority in the country where they
    are being enrolled
    • Willingness to discuss personal topics during an audio-taped group interview
    • Willingness to protect the confidentiality of other focus group participants
    for Stage 1 for Health Care Providers and Professionals:
    • Healthcare providers or professionals (e.g., medical doctors [MDs], nurse
    practitioner [NPs], physician assistants [PAs], adherence counselors) recruited from outside of the local clinical research site (CRS) whose patient population includes a majority of HIV-1 seropositive patients and who have recent experience managing ART-naive individuals starting HAART
    • Men and women who have reached the legal age of majority in the country where they
    are being enrolled
    • Willingness to discuss personal topics during an audio-taped group interview
    • Willingness to protect the confidentiality of other focus group participants and of
    the proceedings for Stage 2:
    • HIV-1 infection
    • Antiretroviral (ARV) treatment naive, but planning to initiate HAART within 7 days of
    study entry either in the context of an approved parent AIDS Clinical Trial Group (ACTG) clinical trial or in the context of primary HIV care at a University of California, San Diego (UCSD) or Y.R. Gaitonde Centre for AIDS Research and Education, Chennai, India (YRG CARE) CRS-affiliated site
    • HIV-1 RNA greater than 2,000 copies/mL obtained within 90 days prior to study entry
    by any laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent
    • Men and women who have reached the legal age of majority in the country where they
    are being enrolled
    • Ability to follow instructions and complete surveys and questionnaires with minimal
    assistance

Criterios de exclusión

    for Stage 1 for HIV-1 Infected Individuals on HAART:
    • Failure to remain on HAART for at least 30 consecutive days
    • Diminished cognitive capacity that, in the opinion of the screening CRS clinician,
    would interfere with study participation
    • Participation in any prior focus group for study A5250

Centros de estudio/contactos

California

    Ucsd, Avrc Crs, San Diego, California, 92037, United States

    Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE), Chennai, California, 92037, India

Actualizado: 16 de noviembre del 2009

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