Back to resultsTelephone Support to Improve Adherence to Anti-HIV Medications
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhanced nursing telephone support
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring Adherence, Treatment, Adherence Intervention, Telephone Intervention, treatment experienced
Eligibility 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
Sites / Locations
- Alabama Therapeutics CRS
- Ucsd, Avrc Crs
- Northwestern University CRS (2701)
- Rush University Medical Center ACTG
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs (104)
- Cooper Univ. Hosp. CRS (31476)
- New Jersey Medical School-Adult Clinical Research Ctr. CRS
- Cornell CRS
- HIV Prevention & Treatment CRS
- Unc Aids Crs
- Duke University Medical Center Adult CRS
- MetroHealth CRS
- Hospital of the University of Pennsylvania CRS
- Vanderbilt Therapeutics CRS
- 31443 Trinity Health and Wellness Center CRS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced nursing telephone support with standard care
Standard care
Arm Description
Participants received enhanced nursing telephone support plus care as usual.
Participants received care as usual.
Outcomes
Primary Outcome Measures
Number of Participants With Virologic Suppression
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
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
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
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
Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.
Confirmed Virologic Failure
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
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
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
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
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)
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)
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
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.
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
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
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
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
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
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
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
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
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
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
Quality of life measured by Euro-QoL - Question 1: Mobility.
Quality of Life Measured by Euro-QoL - Self-Care
Quality of Life Measured by Euro-QoL - Question 2: Self-Care.
Quality of Life Measured by Euro-QoL - Usual Activities
Quality of Life Measured by Euro-QoL - Question 3: Usual activities.
Quality of Life Measured by Euro-QoL - Pain/Discomfort
Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.
Quality of Life Measured by Euro-QoL - Anxiety/Depression
Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.
Full Information
NCT ID
NCT00988442
First Posted
October 1, 2009
Last Updated
April 17, 2017
Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00988442
Brief Title
Telephone Support to Improve Adherence to Anti-HIV Medications
Official Title
A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was closed to recruitment and follow-up early due to low recruitment.
Study Start Date
October 2010 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Adherence, Treatment, Adherence Intervention, Telephone Intervention, treatment experienced
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced nursing telephone support with standard care
Arm Type
Experimental
Arm Description
Participants received enhanced nursing telephone support plus care as usual.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Participants received care as usual.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced nursing telephone support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Usual ACTG site care.
Primary Outcome Measure Information:
Title
Number of Participants With Virologic Suppression
Description
Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation
Description
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.
Time Frame
From study entry to Week 72
Title
Change in CD4 Cell Count at Week 12
Description
Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.
Time Frame
Baseline and Week 12
Title
Change in CD4 Cell Count at Week 24
Description
Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.
Time Frame
Baseline and Week 24
Title
Change in CD4 Cell Count at Week 48
Description
Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.
Time Frame
Baseline and Week 48
Title
Confirmed Virologic Failure
Description
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).
Time Frame
Week 24 through Week 72
Title
Cost of the Adherence Telephone Interventions
Description
This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.
Time Frame
Week 48
Title
Number of Participants With Illness Events or Mortality
Description
Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.
Time Frame
Measured from entry to Week 72 or premature study discontinuation
Title
Number of Participants With Virological Suppression
Description
Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.
Time Frame
Measured from entry to Week 72 or premature study discontinuation
Title
Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period
Description
Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.
Time Frame
Measured from entry to Week 72 or premature study discontinuation
Title
Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)
Description
Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.
Time Frame
Measured at Week 12
Title
Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)
Description
Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.
Time Frame
Week 12
Title
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12
Description
Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.
Time Frame
Week 12
Title
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.
Description
Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.
Time Frame
Week 24
Title
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12
Description
Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.
Time Frame
Week 12
Title
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24
Description
Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.
Time Frame
Week 24
Title
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48
Description
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
Title
Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire
Description
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.
Time Frame
Week 12
Title
Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire
Description
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.
Time Frame
Week 24
Title
Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
Description
ARV medication adherence at week 12, as measured by four day recall, i.e. "Missed doses in last 4 days".
Time Frame
Week 12
Title
Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
Description
ARV medication adherence, as measured by four day recall, i.e. "Missed doses in last 4 days".
Time Frame
Week 24
Title
Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale
Description
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.
Time Frame
Week 12
Title
Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale
Description
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.
Time Frame
Week 24
Title
Quality of Life Measured by Euro-QoL - Mobility
Description
Quality of life measured by Euro-QoL - Question 1: Mobility.
Time Frame
Week 24
Title
Quality of Life Measured by Euro-QoL - Self-Care
Description
Quality of Life Measured by Euro-QoL - Question 2: Self-Care.
Time Frame
Week 24
Title
Quality of Life Measured by Euro-QoL - Usual Activities
Description
Quality of Life Measured by Euro-QoL - Question 3: Usual activities.
Time Frame
Week 24
Title
Quality of Life Measured by Euro-QoL - Pain/Discomfort
Description
Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.
Time Frame
Week 24
Title
Quality of Life Measured by Euro-QoL - Anxiety/Depression
Description
Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy R. Reynolds, PhD, RN, NP
Organizational Affiliation
Yale University School of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Northwestern University CRS (2701)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center ACTG
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs (104)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Cooper Univ. Hosp. CRS (31476)
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New Jersey Medical School-Adult Clinical Research Ctr. CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Cornell CRS
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
HIV Prevention & Treatment CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center Adult CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
MetroHealth CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Hospital of the University of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Therapeutics CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
31443 Trinity Health and Wellness Center CRS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17891043
Citation
Reynolds NR, Testa MA, Su M, Chesney MA, Neidig JL, Frank I, Smith S, Ickovics J, Robbins GK; AIDS Clinical Trials Group 731 and 384 Teams. Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):62-8. doi: 10.1097/QAI.0b013e3181582d54.
Results Reference
background
PubMed Identifier
19668085
Citation
Sitta R, Lert F, Gueguen A, Spire B, Dray-Spira R; VESPA group. No variability across centers in adherence and response to HAART in French hospitals: results from the ANRS-EN12-VESPA study. J Acquir Immune Defic Syndr. 2009 Dec;52(5):643-7. doi: 10.1097/QAI.0b013e3181b26eb9.
Results Reference
background
PubMed Identifier
18349433
Citation
Zaric GS, Bayoumi AM, Brandeau ML, Owens DK. The cost-effectiveness of counseling strategies to improve adherence to highly active antiretroviral therapy among men who have sex with men. Med Decis Making. 2008 May-Jun;28(3):359-76. doi: 10.1177/0272989X07312714. Epub 2008 Mar 18.
Results Reference
background
PubMed Identifier
27347650
Citation
Robbins GK, Cohn SE, Harrison LJ, Smeaton L, Moran L, Rusin D, Dehlinger M, Flynn T, Lammert S, Wu AW, Safren SA, Reynolds NR. Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251. HIV Clin Trials. 2016 Jul;17(4):165-72. doi: 10.1080/15284336.2016.1189754.
Results Reference
result
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Telephone Support to Improve Adherence to Anti-HIV Medications
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