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Telephone Support to Improve Adherence to Anti-HIV Medications

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ClinicalTrials.gov Identifier: NCT00988442
Recruitment Status : Terminated (This study was closed to recruitment and follow-up early due to low recruitment.)
First Posted : October 2, 2009
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

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
Enrollment 59

Recruitment Details Recruitment occurred between April 21, 2011 (first participant enrolled) and October 18, 2012 (last participant enrolled).
Pre-assignment Details 59 participants were randomized 1:1 to standard care and enhanced nursing telephone support with standard care arms.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description

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.

Participants received care as usual.

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

Period Title: Overall Study
Started 30 29
Completed 0 1
Not Completed 30 28
Reason Not Completed
Death             1             2
Lost to Follow-up             0             1
Early Study Closure             29             25
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 30 29 59
Hide Baseline Analysis Population Description
All participants enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 29 participants 59 participants
44.5  (12.2) 46.6  (10.8) 45.5  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Female
10
  33.3%
13
  44.8%
23
  39.0%
Male
20
  66.7%
16
  55.2%
36
  61.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
White Non-Hispanic
3
  10.0%
6
  20.7%
9
  15.3%
Black Non-Hispanic
23
  76.7%
20
  69.0%
43
  72.9%
Hispanic (Regardless of Race)
4
  13.3%
3
  10.3%
7
  11.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 29 participants 59 participants
30
 100.0%
29
 100.0%
59
 100.0%
Intravenous (IV) Drug History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Never
26
  86.7%
25
  86.2%
51
  86.4%
Previously
4
  13.3%
4
  13.8%
8
  13.6%
CD4+ Count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 30 participants 29 participants 59 participants
180
(48 to 314)
157
(82 to 357)
180
(57 to 333)
HIV-1 RNA  
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 30 participants 29 participants 59 participants
4.0
(3.1 to 4.9)
4.5
(3.4 to 4.9)
4.0
(3.2 to 4.9)
1.Primary Outcome
Title Number of Participants With Virologic Suppression
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled who had Week 48 HIV-1 RNA results available were included in this intent-to-treat-analysis. At the time of early study closure, 14 participants had reached week 48.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
4
  57.1%
5
  71.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Nursing Telephone Support With Standard Care, Standard Care
Comments A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments Two-sided 5% significance level.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with available ART data.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 30 28
Measure Type: Number
Unit of Measure: participants
4 7
3.Secondary Outcome
Title Change in CD4 Cell Count at Week 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 22 22
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
11
(-12 to 35)
27
(-12 to 67)
4.Secondary Outcome
Title Change in CD4 Cell Count at Week 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 21 21
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
37
(-3 to 77)
9
(-32 to 51)
5.Secondary Outcome
Title Change in CD4 Cell Count at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 16 participants had week 48 CD4 observations to be included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 8 8
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
63
(-64 to 189)
80
(4 to 156)
6.Secondary Outcome
Title Confirmed Virologic Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants randomized to a treatment arm in this trial.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Virologic Failure
8
  26.7%
7
  24.1%
Virologic Non-failure
6
  20.0%
6
  20.7%
Insufficient Follow Up
16
  53.3%
16
  55.2%
7.Secondary Outcome
Title Cost of the Adherence Telephone Interventions
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome was not analyzed, since the intervention was not determined to be successful.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Illness Events or Mortality
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 59 participants were accrued and followed on study.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Fungal infections
2
   6.7%
5
  17.2%
Bacterial/Mycobacterial infections
5
  16.7%
3
  10.3%
Viral infections
1
   3.3%
4
  13.8%
Neoplastic diseases
1
   3.3%
1
   3.4%
Cardiovascular diseases
5
  16.7%
2
   6.9%
Other Disease - General Diagnoses
6
  20.0%
4
  13.8%
Other Disease - Metabolic/Endocrine
3
  10.0%
0
   0.0%
Other Disease - Pulmonary
4
  13.3%
2
   6.9%
Other Disease - Gastrointestinal
5
  16.7%
4
  13.8%
Other Disease - Genitourinary
1
   3.3%
2
   6.9%
Other Disease - Neuropsychiatric
4
  13.3%
2
   6.9%
Other Disease - Musculoskeletal
1
   3.3%
0
   0.0%
Other Disease - Dermatologic
3
  10.0%
0
   0.0%
Other Disease - STD
0
   0.0%
1
   3.4%
Other HIV Associated Diseases
0
   0.0%
2
   6.9%
Deaths
1
   3.3%
2
   6.9%
9.Secondary Outcome
Title Number of Participants With Virological Suppression
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with scheduled post baseline HIV-1 RNA measurements.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 26 27
Measure Type: Number
Unit of Measure: participants
14 15
10.Secondary Outcome
Title Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants in the telephone support group were analyzed.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 30 0
Measure Type: Number
Unit of Measure: participants
21
11.Secondary Outcome
Title Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants in the telephone support group were analyzed.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 30 0
Mean (Standard Deviation)
Unit of Measure: percent of scheduled calls delivered
34.6  (34.3)
12.Secondary Outcome
Title Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)
Hide Description Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants in the telephone support group were analyzed.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 30 0
Median (Inter-Quartile Range)
Unit of Measure: minutes
19
(0 to 39)
13.Secondary Outcome
Title Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12
Hide Description Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 21 22
Measure Type: Count of Participants
Unit of Measure: Participants
10
  47.6%
12
  54.5%
14.Secondary Outcome
Title Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.
Hide Description Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
10
  45.5%
7
  36.8%
15.Secondary Outcome
Title Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 21 22
Measure Type: Count of Participants
Unit of Measure: Participants
12
  57.1%
13
  59.1%
16.Secondary Outcome
Title Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
11
  50.0%
8
  42.1%
17.Secondary Outcome
Title Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
5
  71.4%
5
  71.4%
18.Secondary Outcome
Title Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 30 participants had complete adherence data for this outcome.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 16 14
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
97
(79 to 99)
93
(83 to 98)
19.Secondary Outcome
Title Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, 31 participants had complete adherence data for this outcome.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 15 16
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
91
(52 to 99)
95
(67 to 98)
20.Secondary Outcome
Title Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 42 participants had adherence data at week 12 for this outcome.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 23 19
Measure Type: Count of Participants
Unit of Measure: Participants
Missed Doses: 0
17
  73.9%
16
  84.2%
Missed Doses: 1-2
0
   0.0%
1
   5.3%
Missed Doses: 3-4
3
  13.0%
1
   5.3%
Missed Doses: 5+
3
  13.0%
1
   5.3%
21.Secondary Outcome
Title Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
Hide Description ARV medication adherence, as measured by four day recall, i.e. "Missed doses in last 4 days".
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 39 participants had adherence data at week 24.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 21 18
Measure Type: Count of Participants
Unit of Measure: Participants
Missed Doses: 0
12
  57.1%
11
  61.1%
Missed Doses: 1-2
1
   4.8%
1
   5.6%
Missed Doses: 3-4
2
   9.5%
3
  16.7%
Missed Doses: 5+
6
  28.6%
3
  16.7%
22.Secondary Outcome
Title Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 23 21
Median (Inter-Quartile Range)
Unit of Measure: percentage of HIV meds taken last month
95
(55 to 100)
95
(85 to 100)
23.Secondary Outcome
Title Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 21 19
Median (Inter-Quartile Range)
Unit of Measure: percentage of HIV meds taken last month
95
(60 to 100)
95
(70 to 100)
24.Secondary Outcome
Title Quality of Life Measured by Euro-QoL - Mobility
Hide Description Quality of life measured by Euro-QoL - Question 1: Mobility.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available data for participants that reached week 24 are summarized.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
No problems walking
18
  81.8%
11
  57.9%
Some problems walking
4
  18.2%
8
  42.1%
25.Secondary Outcome
Title Quality of Life Measured by Euro-QoL - Self-Care
Hide Description Quality of Life Measured by Euro-QoL - Question 2: Self-Care.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data from participants that reached week 24 are summarized.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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.

Participants received care as usual.

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

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
No problems with self-care
21
  95.5%
18
  94.7%
Some problems washing or dressing
1
   4.5%
1
   5.3%
26.Secondary Outcome
Title Quality of Life Measured by Euro-QoL - Usual Activities
Hide Description Quality of Life Measured by Euro-QoL - Question 3: Usual activities.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data from participants that reached week 24 are summarized.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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: Usual ACTG site care.

Participants received care as usual.

Standard care: Usual ACTG site care.

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
No problems performing usual activities
20
  90.9%
16
  84.2%
Some probs performing usual activities
1
   4.5%
3
  15.8%
Unable to perform usual activities
1
   4.5%
0
   0.0%
27.Secondary Outcome
Title Quality of Life Measured by Euro-QoL - Pain/Discomfort
Hide Description Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available data from participants who reached week 24 are summarized.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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: Usual ACTG site care.

Participants received care as usual.

Standard care: Usual ACTG site care.

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
No pain or discomfort
14
  63.6%
9
  47.4%
Moderate pain or discomfort
6
  27.3%
5
  26.3%
Extreme pain or discomfort
2
   9.1%
5
  26.3%
28.Secondary Outcome
Title Quality of Life Measured by Euro-QoL - Anxiety/Depression
Hide Description Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available data from participants who made it to week 24 are summarized.
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description:

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: Usual ACTG site care.

Participants received care as usual.

Standard care: Usual ACTG site care.

Overall Number of Participants Analyzed 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
Not anxious or depressed
17
  77.3%
10
  52.6%
Moderately anxious or depressed
3
  13.6%
8
  42.1%
Extremely anxious or depressed
2
   9.1%
1
   5.3%
Time Frame Measured from entry to Week 72 or premature study discontinuation
Adverse Event Reporting Description No adverse event data other than number of deaths were collected in this study.
 
Arm/Group Title Enhanced Nursing Telephone Support With Standard Care Standard Care
Hide Arm/Group Description

Participants will receive 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 may schedule more frequent calls at their discretion. Calls will provide information, motivational enhancement, problem-solving skills, and affective support.

Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site.

Participants will receive care as usual.

Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site.

All-Cause Mortality
Enhanced Nursing Telephone Support With Standard Care Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   2/29 (6.90%) 
Show Serious Adverse Events Hide Serious Adverse Events
Enhanced Nursing Telephone Support With Standard Care Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enhanced Nursing Telephone Support With Standard Care Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
This study was closed to recruitment and follow-up early due to slow enrollment.
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
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