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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
October 1, 2009
April 17, 2017
October 2010
February 2013   (Final data collection date for primary outcome measure)
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.
Virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL [ Time Frame: Measured at Week 48 ]
Complete list of historical versions of study NCT00988442 on ClinicalTrials.gov Archive Site
  • 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.
  • Antiretroviral (ARV) medication adherence [ Time Frame: Measured at Weeks 12, 24, 48, and 72 ]
  • Time to antiretroviral therapy (ART) regimen discontinuation [ Time Frame: Measured throughout ]
  • Quality of life [ Time Frame: Measured at Weeks 24, 48, and 72 ]
  • CD4 cell count [ Time Frame: Measured at Weeks 12, 24, 48, and 72 ]
  • Cost of the adherence telephone interventions, if the intervention is successful [ Time Frame: Measured at Week 48 ]
  • Symptom distress, illness events, or mortality [ Time Frame: Measured throughout the study ]
  • Virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL [ Time Frame: Measured at Week 48 ]
  • Virological suppression, defined as both HIV-1 RNA less than 200 and less than 1,000 copies/mL [ Time Frame: Measured at Weeks 12, 24, and 72 ]
  • Time to virologic failure, with virologic failure defined as confirmed HIV-1 RNA of at least 200 copies/mL at or after 24 weeks [ Time Frame: Measured on Weeks 24, 48, and 72 ]
  • Time to first virological suppression, defined as HIV-1 RNA less than 200 copies/mL [ Time Frame: Measured at Weeks 12, 24, 48, and 72 ]
  • Time to discontinuation of enhanced nursing telephone adherence intervention [ Time Frame: Measured throughout ]
  • Intervention dosage score for enhanced nursing telephone support, including total percentage of scheduled calls successfully delivered and total amount of time spent in calls [ Time Frame: Measured at Week 72 ]
Not Provided
Not Provided
 
Telephone Support to Improve Adherence to Anti-HIV Medications
A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Supportive Care
HIV Infections
  • 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.
  • Experimental: Enhanced nursing telephone support with standard care
    Participants received enhanced nursing telephone support plus care as usual.
    Interventions:
    • Behavioral: Enhanced nursing telephone support
    • Behavioral: Standard care
  • Active Comparator: Standard care
    Participants received care as usual.
    Intervention: Behavioral: Standard care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
59
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Puerto Rico
 
NCT00988442
ACTG A5251
1U01AI068636 ( U.S. NIH Grant/Contract )
10632
Yes
Not Provided
Not Provided
AIDS Clinical Trials Group
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Nancy R. Reynolds, PhD, RN, NP Yale University School of Nursing
AIDS Clinical Trials Group
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP