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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:
ClinicalTrials.gov Identifier:
NCT00988442
First Posted: October 2, 2009
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
Results First Submitted: February 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition: HIV Infections
Interventions: Behavioral: Enhanced nursing telephone support
Behavioral: Standard care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between April 21, 2011 (first participant enrolled) and October 18, 2012 (last participant enrolled).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
59 participants were randomized 1:1 to standard care and enhanced nursing telephone support with standard care arms.

Reporting Groups
  Description
Enhanced Nursing Telephone Support With Standard Care

Participants received enhanced nursing telephone support plus care as usual.

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.

Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.

Standard Care

Participants received care as usual.

Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.


Participant Flow:   Overall Study
    Enhanced Nursing Telephone Support With Standard Care   Standard Care
STARTED   30   29 
COMPLETED   0   1 
NOT COMPLETED   30   28 
Death                1                2 
Lost to Follow-up                0                1 
Early Study Closure                29                25 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants enrolled in the study.

Reporting Groups
  Description
Enhanced Nursing Telephone Support With Standard Care

Participants received enhanced nursing telephone support plus care as usual.

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.

Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.

Standard Care

Participants received care as usual.

Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.

Total Total of all reporting groups

Baseline Measures
   Enhanced Nursing Telephone Support With Standard Care   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   29   59 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (12.2)   46.6  (10.8)   45.5  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  33.3%      13  44.8%      23  39.0% 
Male      20  66.7%      16  55.2%      36  61.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White Non-Hispanic   3   6   9 
Black Non-Hispanic   23   20   43 
Hispanic (Regardless of Race)   4   3   7 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   30   29   59 
Intravenous (IV) Drug History 
[Units: Participants]
Count of Participants
     
Never   26   25   51 
Previously   4   4   8 
CD4+ Count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 180 
 (48 to 314) 
 157 
 (82 to 357) 
 180 
 (57 to 333) 
HIV-1 RNA 
[Units: Log10 copies/mL]
Median (Inter-Quartile Range)
 4.0 
 (3.1 to 4.9) 
 4.5 
 (3.4 to 4.9) 
 4.0 
 (3.2 to 4.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Virologic Suppression   [ Time Frame: Week 48 ]

2.  Secondary:   Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation   [ Time Frame: From study entry to Week 72 ]

3.  Secondary:   Change in CD4 Cell Count at Week 12   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change in CD4 Cell Count at Week 24   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Change in CD4 Cell Count at Week 48   [ Time Frame: Baseline and Week 48 ]

6.  Secondary:   Confirmed Virologic Failure   [ Time Frame: Week 24 through Week 72 ]

7.  Secondary:   Cost of the Adherence Telephone Interventions   [ Time Frame: Week 48 ]

8.  Secondary:   Number of Participants With Illness Events or Mortality   [ Time Frame: Measured from entry to Week 72 or premature study discontinuation ]

9.  Secondary:   Number of Participants With Virological Suppression   [ Time Frame: Measured from entry to Week 72 or premature study discontinuation ]

10.  Secondary:   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 ]

11.  Secondary:   Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)   [ Time Frame: Measured at Week 12 ]

12.  Secondary:   Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)   [ Time Frame: Week 12 ]

13.  Secondary:   Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12   [ Time Frame: Week 12 ]

14.  Secondary:   Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.   [ Time Frame: Week 24 ]

15.  Secondary:   Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12   [ Time Frame: Week 12 ]

16.  Secondary:   Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24   [ Time Frame: Week 24 ]

17.  Secondary:   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 ]

18.  Secondary:   Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire   [ Time Frame: Week 12 ]

19.  Secondary:   Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire   [ Time Frame: Week 24 ]

20.  Secondary:   Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall   [ Time Frame: Week 12 ]

21.  Secondary:   Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall   [ Time Frame: Week 24 ]

22.  Secondary:   Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale   [ Time Frame: Week 12 ]

23.  Secondary:   Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale   [ Time Frame: Week 24 ]

24.  Secondary:   Quality of Life Measured by Euro-QoL - Mobility   [ Time Frame: Week 24 ]

25.  Secondary:   Quality of Life Measured by Euro-QoL - Self-Care   [ Time Frame: Week 24 ]

26.  Secondary:   Quality of Life Measured by Euro-QoL - Usual Activities   [ Time Frame: Week 24 ]

27.  Secondary:   Quality of Life Measured by Euro-QoL - Pain/Discomfort   [ Time Frame: Week 24 ]

28.  Secondary:   Quality of Life Measured by Euro-QoL - Anxiety/Depression   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was closed to recruitment and follow-up early due to slow enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 6283313
e-mail: ACTGCT.Gov@s-3.com


Publications of Results:
Other 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
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: February 13, 2017
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017