Trial Outcomes & Findings for Telephone Support to Improve Adherence to Anti-HIV Medications (NCT NCT00988442)
NCT ID: NCT00988442
Last Updated: 2017-07-17
Results Overview
Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Week 48
Results posted on
2017-07-17
Participant Flow
Recruitment occurred between April 21, 2011 (first participant enrolled) and October 18, 2012 (last participant enrolled).
59 participants were randomized 1:1 to standard care and enhanced nursing telephone support with standard care arms.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
30
|
28
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Early Study Closure
|
29
|
25
|
Baseline Characteristics
Telephone Support to Improve Adherence to Anti-HIV Medications
Baseline characteristics by cohort
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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
n=29 Participants
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
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Intravenous (IV) Drug History
Never
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Intravenous (IV) Drug History
Previously
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
CD4+ Count
|
180 cells/mm^3
n=5 Participants
|
157 cells/mm^3
n=7 Participants
|
180 cells/mm^3
n=5 Participants
|
|
HIV-1 RNA
|
4.0 log10 copies/mL
n=5 Participants
|
4.5 log10 copies/mL
n=7 Participants
|
4.0 log10 copies/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: 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.
Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=7 Participants
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
n=7 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virologic Suppression
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From study entry to Week 72Population: All participants with available ART data.
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.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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
n=28 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis.
Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=22 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Change in CD4 Cell Count at Week 12
|
11 cells/mm^3
Interval -12.0 to 35.0
|
27 cells/mm^3
Interval -12.0 to 67.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis.
Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=21 Participants
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
n=21 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Change in CD4 Cell Count at Week 24
|
37 cells/mm^3
Interval -3.0 to 77.0
|
9 cells/mm^3
Interval -32.0 to 51.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Only 16 participants had week 48 CD4 observations to be included in this analysis.
Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=8 Participants
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
n=8 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Change in CD4 Cell Count at Week 48
|
63 cells/mm^3
Interval -64.0 to 189.0
|
80 cells/mm^3
Interval 4.0 to 156.0
|
SECONDARY outcome
Timeframe: Week 24 through Week 72Population: The analysis population was all participants randomized to a treatment arm in this trial.
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).
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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
n=29 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Confirmed Virologic Failure
Virologic Failure
|
8 Participants
|
7 Participants
|
|
Confirmed Virologic Failure
Virologic Non-failure
|
6 Participants
|
6 Participants
|
|
Confirmed Virologic Failure
Insufficient Follow Up
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: This outcome was not analyzed, since the intervention was not determined to be successful.
This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.
Outcome measures
| Measure |
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.
|
|---|---|---|
|
Cost of the Adherence Telephone Interventions
|
0
|
0
|
SECONDARY outcome
Timeframe: Measured from entry to Week 72 or premature study discontinuationPopulation: Due to early study closure, only 59 participants were accrued and followed on study.
Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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
n=29 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Illness Events or Mortality
Fungal infections
|
2 Participants
|
5 Participants
|
|
Number of Participants With Illness Events or Mortality
Bacterial/Mycobacterial infections
|
5 Participants
|
3 Participants
|
|
Number of Participants With Illness Events or Mortality
Viral infections
|
1 Participants
|
4 Participants
|
|
Number of Participants With Illness Events or Mortality
Neoplastic diseases
|
1 Participants
|
1 Participants
|
|
Number of Participants With Illness Events or Mortality
Cardiovascular diseases
|
5 Participants
|
2 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - General Diagnoses
|
6 Participants
|
4 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Metabolic/Endocrine
|
3 Participants
|
0 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Pulmonary
|
4 Participants
|
2 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Gastrointestinal
|
5 Participants
|
4 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Genitourinary
|
1 Participants
|
2 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Neuropsychiatric
|
4 Participants
|
2 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Musculoskeletal
|
1 Participants
|
0 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - Dermatologic
|
3 Participants
|
0 Participants
|
|
Number of Participants With Illness Events or Mortality
Other Disease - STD
|
0 Participants
|
1 Participants
|
|
Number of Participants With Illness Events or Mortality
Other HIV Associated Diseases
|
0 Participants
|
2 Participants
|
|
Number of Participants With Illness Events or Mortality
Deaths
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured from entry to Week 72 or premature study discontinuationPopulation: All participants with scheduled post baseline HIV-1 RNA measurements.
Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=26 Participants
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
n=27 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virological Suppression
|
14 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Measured from entry to Week 72 or premature study discontinuationPopulation: Only participants in the telephone support group were analyzed.
Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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.
|
|---|---|---|
|
Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period
|
21 participants
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 12Population: Only participants in the telephone support group were analyzed.
Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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.
|
|---|---|---|
|
Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)
|
34.6 percent of scheduled calls delivered
Standard Deviation 34.3
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Only participants in the telephone support group were analyzed.
Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=30 Participants
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.
|
|---|---|---|
|
Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)
|
19 minutes
Interval 0.0 to 39.0
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis.
Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=21 Participants
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
n=22 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.
Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis.
Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=21 Participants
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
n=22 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.
Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Measured at Week 48Population: Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis.
Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=7 Participants
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
n=7 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Due to early study closure, only 30 participants had complete adherence data for this outcome.
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.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=16 Participants
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
n=14 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire
|
97 units on a scale
Interval 79.0 to 99.0
|
93 units on a scale
Interval 83.0 to 98.0
|
SECONDARY outcome
Timeframe: Week 24Population: Due to early study closure, 31 participants had complete adherence data for this outcome.
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.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=15 Participants
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
n=16 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire
|
91 units on a scale
Interval 52.0 to 99.0
|
95 units on a scale
Interval 67.0 to 98.0
|
SECONDARY outcome
Timeframe: Week 12Population: Due to early study closure, only 42 participants had adherence data at week 12 for this outcome.
ARV medication adherence at week 12, as measured by four day recall, i.e. "Missed doses in last 4 days".
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=23 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
Missed Doses: 0
|
17 Participants
|
16 Participants
|
|
Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
Missed Doses: 1-2
|
0 Participants
|
1 Participants
|
|
Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
Missed Doses: 3-4
|
3 Participants
|
1 Participants
|
|
Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
Missed Doses: 5+
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Due to early study closure, only 39 participants had adherence data at week 24.
ARV medication adherence, as measured by four day recall, i.e. "Missed doses in last 4 days".
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=21 Participants
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
n=18 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
Missed Doses: 0
|
12 Participants
|
11 Participants
|
|
Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
Missed Doses: 1-2
|
1 Participants
|
1 Participants
|
|
Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
Missed Doses: 3-4
|
2 Participants
|
3 Participants
|
|
Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
Missed Doses: 5+
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome.
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.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=23 Participants
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
n=21 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale
|
95 percentage of HIV meds taken last month
Interval 55.0 to 100.0
|
95 percentage of HIV meds taken last month
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 24Population: Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome.
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.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=21 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale
|
95 percentage of HIV meds taken last month
Interval 60.0 to 100.0
|
95 percentage of HIV meds taken last month
Interval 70.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 24Population: Available data for participants that reached week 24 are summarized.
Quality of life measured by Euro-QoL - Question 1: Mobility.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Quality of Life Measured by Euro-QoL - Mobility
No problems walking
|
18 Participants
|
11 Participants
|
|
Quality of Life Measured by Euro-QoL - Mobility
Some problems walking
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All available data from participants that reached week 24 are summarized.
Quality of Life Measured by Euro-QoL - Question 2: Self-Care.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Quality of Life Measured by Euro-QoL - Self-Care
No problems with self-care
|
21 Participants
|
18 Participants
|
|
Quality of Life Measured by Euro-QoL - Self-Care
Some problems washing or dressing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All available data from participants that reached week 24 are summarized.
Quality of Life Measured by Euro-QoL - Question 3: Usual activities.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Quality of Life Measured by Euro-QoL - Usual Activities
No problems performing usual activities
|
20 Participants
|
16 Participants
|
|
Quality of Life Measured by Euro-QoL - Usual Activities
Some probs performing usual activities
|
1 Participants
|
3 Participants
|
|
Quality of Life Measured by Euro-QoL - Usual Activities
Unable to perform usual activities
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Available data from participants who reached week 24 are summarized.
Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Quality of Life Measured by Euro-QoL - Pain/Discomfort
No pain or discomfort
|
14 Participants
|
9 Participants
|
|
Quality of Life Measured by Euro-QoL - Pain/Discomfort
Moderate pain or discomfort
|
6 Participants
|
5 Participants
|
|
Quality of Life Measured by Euro-QoL - Pain/Discomfort
Extreme pain or discomfort
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Available data from participants who made it to week 24 are summarized.
Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.
Outcome measures
| Measure |
Enhanced Nursing Telephone Support With Standard Care
n=22 Participants
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
n=19 Participants
Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site.
|
|---|---|---|
|
Quality of Life Measured by Euro-QoL - Anxiety/Depression
Extremely anxious or depressed
|
2 Participants
|
1 Participants
|
|
Quality of Life Measured by Euro-QoL - Anxiety/Depression
Not anxious or depressed
|
17 Participants
|
10 Participants
|
|
Quality of Life Measured by Euro-QoL - Anxiety/Depression
Moderately anxious or depressed
|
3 Participants
|
8 Participants
|
Adverse Events
Enhanced Nursing Telephone Support With Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 6283313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place