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Telephone Support to Improve Adherence to Anti-HIV Medications

This study has been terminated.
(This study was closed to recruitment and follow-up early due to low recruitment.)
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00988442
First received: October 1, 2009
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
This study tested a system of nursing telephone support to determine if it improves adherence to antiretroviral therapy (ART) in at-risk, treatment-experienced people.

Condition Intervention Phase
HIV Infections Behavioral: Enhanced nursing telephone support Behavioral: Standard care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Number of Participants With Virologic Suppression [ Time Frame: Week 48 ]
    Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.


Secondary Outcome Measures:
  • Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation [ Time Frame: From study entry to Week 72 ]
    Number of premature ART regimen discontinuations, defined as the first substitution, subtraction, or addition of one or more ARVs made to the initial study regimen.

  • Change in CD4 Cell Count at Week 12 [ Time Frame: Baseline and Week 12 ]
    Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.

  • Change in CD4 Cell Count at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.

  • Change in CD4 Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.

  • Confirmed Virologic Failure [ Time Frame: Week 24 through Week 72 ]
    Number of participants with confirmed virologic failure. Virologic failure is defined as confirmed HIV-1 RNA ≥200 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 20 weeks after the date of randomization).

  • Cost of the Adherence Telephone Interventions [ Time Frame: Week 48 ]
    This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.

  • Number of Participants With Illness Events or Mortality [ Time Frame: Measured from entry to Week 72 or premature study discontinuation ]
    Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.

  • Number of Participants With Virological Suppression [ Time Frame: Measured from entry to Week 72 or premature study discontinuation ]
    Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.

  • Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period [ Time Frame: Measured from entry to Week 72 or premature study discontinuation ]
    Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.

  • Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered) [ Time Frame: Measured at Week 12 ]
    Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.

  • Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls) [ Time Frame: Week 12 ]
    Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.

  • Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12 [ Time Frame: Week 12 ]
    Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.

  • Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24. [ Time Frame: Week 24 ]
    Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.

  • Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12 [ Time Frame: Week 12 ]
    Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.

  • Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24 [ Time Frame: Week 24 ]
    Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.

  • Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48 [ Time Frame: Measured at Week 48 ]
    Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48.

  • Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire [ Time Frame: Week 12 ]
    ARV medication adherence at week 12, as measured by the ACTG adherence questionnaire index. This questionnaire index is on a 0-100 scale, with higher scores indicating higher adherence.

  • Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire [ Time Frame: Week 24 ]
    ARV medication adherence at week 24, as measured by the ACTG adherence questionnaire index. The ACTG adherence questionnaire index is on a 0-100 scale where higher scores indicate better adherence.

  • Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall [ Time Frame: Week 12 ]
    ARV medication adherence at week 12, as measured by four day recall, i.e. "Missed doses in last 4 days".

  • Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall [ Time Frame: Week 24 ]
    ARV medication adherence, as measured by four day recall, i.e. "Missed doses in last 4 days".

  • Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale [ Time Frame: Week 12 ]
    ARV medication adherence at week 12, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.

  • Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale [ Time Frame: Week 24 ]
    ARV medication adherence at Week 24, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.

  • Quality of Life Measured by Euro-QoL - Mobility [ Time Frame: Week 24 ]
    Quality of life measured by Euro-QoL - Question 1: Mobility.

  • Quality of Life Measured by Euro-QoL - Self-Care [ Time Frame: Week 24 ]
    Quality of Life Measured by Euro-QoL - Question 2: Self-Care.

  • Quality of Life Measured by Euro-QoL - Usual Activities [ Time Frame: Week 24 ]
    Quality of Life Measured by Euro-QoL - Question 3: Usual activities.

  • Quality of Life Measured by Euro-QoL - Pain/Discomfort [ Time Frame: Week 24 ]
    Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.

  • Quality of Life Measured by Euro-QoL - Anxiety/Depression [ Time Frame: Week 24 ]
    Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.


Enrollment: 59
Actual Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced nursing telephone support with standard care
Participants received enhanced nursing telephone support plus care as usual.
Behavioral: Enhanced nursing telephone support
Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Behavioral: Standard care
Usual ACTG site care.
Active Comparator: Standard care
Participants received care as usual.
Behavioral: Standard care
Usual ACTG site care.

Detailed Description:

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 tested an enhanced telephone support intervention provided by nurses that aimed to improve ART adherence and treatment outcomes.

Follow-up for this study lasted 72 weeks. Participants were randomly assigned to receive either care as usual or the enhanced telephone support intervention plus care as usual. The telephone support intervention involved phone calls made weekly for the first 8 weeks of the study and then every 2 weeks for the next 40 weeks. Nurses made these calls at a time and place participants chose. During the calls, nurses provided information, motivational enhancement, and problem-solving skills.

Study assessments took place at study entry and after 12, 24, 48, and 72 weeks. Assessments measured CD4 cell count, HIV viral load, adherence, and illness events. Adherence was measured through questionnaires and an electronic pill cap.

This study was closed early to both accrual and follow-up due to low recruitment. The study aimed to enroll 296 participants. The actual study accrual at the time of early closing was 59 participants.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved A5251 parent or coenrolling partner study ("ACTG parent study participant") or not enrolled in one of the ACTG parent studies, but receiving routine HIV patient care at an institution that was also an ACTG-funded site ("ACTG clinic patient participant").
  • 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. Availability of HIV-1 genotype results 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 200 copies/mL, obtained within 90 days prior to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA
  • Initiating or restarting an ART regimen with 2 or more active ARV medications within 3 days after randomization. The regimen must have been selected for the participant prior to the time of randomization for A5251. An active ARV medication was defined as a medication to which the participant was expected to be susceptible based on HIV-1 resistance testing, as specified in the ACTG parent study, or determined by the participant's health care provider per standard of care.

Exclusion Criteria:

  • No regular access to a phone. Candidates without phones may have elected 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 have compromised the candidate's ability to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988442

Locations
United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
United States, California
Ucsd, Avrc Crs
San Diego, California, United States, 92103
United States, Illinois
Northwestern University CRS (2701)
Chicago, Illinois, United States, 60611
Rush University Medical Center ACTG
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Bmc Actg Crs (104)
Boston, Massachusetts, United States, 02118
United States, New Jersey
Cooper Univ. Hosp. CRS (31476)
Camden, New Jersey, United States, 08103
New Jersey Medical School-Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States, 07103
United States, New York
Cornell CRS
New York, New York, United States, 10011
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center Adult CRS
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth CRS
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Hospital of the University of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States, 37232
United States, Texas
31443 Trinity Health and Wellness Center CRS
Dallas, Texas, United States, 75208
Sponsors and Collaborators
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Nancy R. Reynolds, PhD, RN, NP Yale University School of Nursing
  More Information

Publications:
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00988442     History of Changes
Other Study ID Numbers: ACTG A5251
1U01AI068636 ( U.S. NIH Grant/Contract )
10632
Study First Received: October 1, 2009
Results First Received: February 13, 2017
Last Updated: April 17, 2017

Keywords provided by AIDS Clinical Trials Group:
Adherence
Treatment
Adherence Intervention
Telephone Intervention
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 19, 2017