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Ensayos clínicos

Ensayos clínicos

Telephone Support to Improve Adherence to Anti-HIV Medications

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00988442, ACTG A5251
  • En curso, con inscripciones cerradas

Propósito del estudio

This study will test a system of nursing telephone support to see if it improves adherence to antiretroviral therapy (ART) in at-risk, treatment-experienced people.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

Antiretroviral therapy (ART) is only successful in treating HIV when people take all the

medications prescribed to them when and how they are instructed. However, a third or more of

patients on ART are not able to adhere to their medication regimens. Therefore, making sure

that these patients stay healthy involves making sure they are motivated and informed about

the importance of adhering to their ART. Nurses can deliver interventions to motivate and

inform patients through regularly scheduled phone calls. These calls allow nurses to check

in between clinic visits, are convenient to patients, and are cost efficient. This study

will test an enhanced telephone support intervention provided by nurses that aims to improve

ART adherence and treatment outcomes.



Participation in this study will last 48 weeks, with follow-up lasting 72 weeks.

Participants will be randomly assigned to receive either care as usual or the enhanced

telephone support intervention plus care as usual. The telephone support intervention will

involve phone calls made weekly for the first 8 weeks of the study and then every 2 weeks

for the next 40 weeks. Nurses will make these calls at a time and place participants choose.

During the calls, nurses will provide information, motivational enhancement, and

problem-solving skills.



Study assessments will take place at study entry and after 12, 24, 48, and 72 weeks.

Assessments will measure CD4 cell count, HIV viral load, adherence, and illness events.

Adherence will be measured through questionnaires and an electronic pill cap.Antiretroviral therapy (ART) is only successful in treating HIV when people take all the

medications prescribed to them when and how they are instructed. However, a third or more of

patients on ART are not able to adhere to their medication regimens. Therefore, making sure

that these patients stay healthy involves making sure they are motivated and informed about

the importance of adhering to their ART. Nurses can deliver interventions to motivate and

inform patients through regularly scheduled phone calls. These calls allow nurses to check

in between clinic visits, are convenient to patients, and are cost efficient. This study

will test an enhanced telephone support intervention provided by nurses that aims to improve

ART adherence and treatment outcomes.



Participation in this study will last 48 weeks, with follow-up lasting 72 weeks.

Participants will be randomly assigned to receive either care as usual or the enhanced

telephone support intervention plus care as usual. The telephone support intervention will

involve phone calls made weekly for the first 8 weeks of the study and then every 2 weeks

for the next 40 weeks. Nurses will make these calls at a time and place participants choose.

During the calls, nurses will provide information, motivational enhancement, and

problem-solving skills.



Study assessments will take place at study entry and after 12, 24, 48, and 72 weeks.

Assessments will measure CD4 cell count, HIV viral load, adherence, and illness events.

Adherence will be measured through questionnaires and an electronic pill cap.

Criterios de inclusión

    :
    • Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved A5251 parent or coenrolling partner study
    • Virologic failure on combination antiretroviral therapy (ART), with an HIV-1 genotype conducted on or soon after the failure, within 16 weeks prior to entry. HIV-1 genotype results must be available at entry.
    • History of prior nonadherence to ART during the past year documented either by patient self-report or recorded in the patient's medical record
    • Most recent HIV-1 RNA value of at least 400 copies/mL, obtained within 90 days prior to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA
      • Initiating a new ART regimen within 3 days after randomization with two or more new
      antiretroviral (ARV) medications to which the participant is expected to be susceptible based on HIV-1 genotype, as specified in the parent or coenrolling partner study or determined by the site investigator. The regimen must be selected for the participant prior to the time of randomization for A5251.
      • Ability to have CD4+ cell count and plasma HIV-1 RNA assays as a component of the
      parent or coenrolling partner study or per other mechanism. Only HIV-1 RNA at week 48 and confirmation of virologic failure will be collected by A5251, unless collected by the parent or coenrolling partner study per exact A5251 specifications.

Criterios de exclusión

    :
    • No regular access to a phone. Candidates without phones may elect to participate by
    calling the HIV nurse specialists using an 800 number, rather than being called by the HIV nurse specialist.
    • Coenrollment in another adherence trial, unless approved by the A5251 study chair
    • Current incarceration
    • Any condition that, in the opinion of the site investigator, would compromise the
    candidate's ability to participate in the study

Centros de estudio/contactos

Alabama

    Alabama Therapeutics CRS, Birmingham, Alabama, 35294, United States

California

    Ucsd, Avrc Crs, San Diego, California, 92103, United States

Colorado

    University of Colorado Hospital CRS, Aurora, Colorado, 80045, United States

District of Columbia

    Georgetown University CRS, Washington, District of Columbia, 20007, United States

Illinois

    Rush University Medical Center ACTG, Chicago, Illinois, 60612, United States

    Northwestern University CRS (2701), Chicago, Illinois, 60611, United States

Massachusetts

    Massachusetts General Hospital ACTG CRS, Boston, Massachusetts, 02114, United States

    Brigham and Women's Hospital ACTG CRS, Boston, Massachusetts, 02115, United States

    Bmc Actg Crs (104), Boston, Massachusetts, 02118, United States

Missouri

    Washington University CRS, St. Louis, Missouri, 63110, United States

New Jersey

    Cooper Univ. Hosp. CRS (31476), Camden, New Jersey, 08103, United States

    New Jersey Medical School-Adult Clinical Research Ctr. CRS, Newark, New Jersey, 07103, United States

New York

    Cornell CRS, New York, New York, 10011, United States

    HIV Prevention & Treatment CRS, New York, New York, 10032, United States

North Carolina

    Unc Aids Crs, Chapel Hill, North Carolina, 27514, United States

    Duke University Medical Center Adult CRS, Durham, North Carolina, 27710, United States

    Moses H. Cone Memorial Hospital CRS, Greensboro, North Carolina, 27401, United States

Ohio

    University of Cincinnati CRS, Cincinnati, Ohio, 45267, United States

    MetroHealth CRS, Cleveland, Ohio, 44109, United States

    Case CRS, Cleveland, Ohio, 44106, United States

    The Ohio State University AIDS CRS, Columbus, Ohio, 43210, United States

Pennsylvania

    Hospital of the University of Pennsylvania CRS, Philadelphia, Pennsylvania, 19104, United States

    Pitt CRS, Pittsburgh, Pennsylvania, 15213, United States

Rhode Island

    The Miriam Hospital ACTG CRS, Providence, Rhode Island, 02906, United States

Tennessee

    Vanderbilt Therapeutics CRS, Nashville, Tennessee, 37232, United States

    Puerto Rico AIDS CRS, San Juan, Tennessee, 00935, Puerto Rico

Actualizado: 22 de octubre del 2009

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