Trial Outcomes & Findings for Improving Treatment Adherence in HIV-Infected Individuals (NCT NCT00247611)
NCT ID: NCT00247611
Last Updated: 2013-12-20
Results Overview
This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained. See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee \& adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266.
COMPLETED
PHASE2
594 participants
Measured at each clinical care visit over 18 months of participation
2013-12-20
Participant Flow
HIV + patients were recruited via provider referral and notices about the study posted in five large HIV care clinics in Connecticut, USA.
Participant milestones
| Measure |
Control
Participants will receive the control condition
|
Intervention
Participants will receive the LifeWindows Intervention sessions
|
|---|---|---|
|
Baselined
STARTED
|
304
|
290
|
|
Baselined
COMPLETED
|
287
|
277
|
|
Baselined
NOT COMPLETED
|
17
|
13
|
|
Intention to Treat Sample
STARTED
|
304
|
290
|
|
Intention to Treat Sample
COMPLETED
|
287
|
277
|
|
Intention to Treat Sample
NOT COMPLETED
|
17
|
13
|
|
On Protocol Sample
STARTED
|
287
|
277
|
|
On Protocol Sample
COMPLETED
|
176
|
152
|
|
On Protocol Sample
NOT COMPLETED
|
111
|
125
|
Reasons for withdrawal
| Measure |
Control
Participants will receive the control condition
|
Intervention
Participants will receive the LifeWindows Intervention sessions
|
|---|---|---|
|
Baselined
Completed baseline, never placed on ARVs
|
8
|
5
|
|
Baselined
Completed baseline only
|
9
|
8
|
Baseline Characteristics
Improving Treatment Adherence in HIV-Infected Individuals
Baseline characteristics by cohort
| Measure |
Control
n=304 Participants
Participants will receive the control condition
|
Intervention
n=290 Participants
Participants will receive the LifeWindows Intervention sessions
|
Total
n=594 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
174 participants
n=5 Participants
|
149 participants
n=7 Participants
|
323 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Continuous
|
47.28 years
STANDARD_DEVIATION 8.01 • n=5 Participants
|
46.76 years
STANDARD_DEVIATION 8.00 • n=7 Participants
|
47 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Gender
Female
|
72 participants
n=5 Participants
|
66 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Gender
Male
|
104 participants
n=5 Participants
|
86 participants
n=7 Participants
|
190 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
304 participants
n=5 Participants
|
290 participants
n=7 Participants
|
594 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at each clinical care visit over 18 months of participationPopulation: Intent to treat included all participants with \>=2 adherence assessments; OP sample further restricted this sample to those with \>=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparison replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.
This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained. See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee \& adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266.
Outcome measures
| Measure |
Control (ITT Sample %)
n=287 Participants
287 (94%) of the 304 randomized to control
|
Intervention (ITT Sample)
n=277 Participants
277 (96%) of the 290 randomized to Intervention condition
|
Control (On Protocol Sample)
n=176 Participants
176 (61%) of the ITT included control arm participants
|
Intervention (On Protocol)
n=152 Participants
152 (55%) of the ITT included intervention arm participants
|
|---|---|---|---|---|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
1 LifeWindows Visit (%)
|
72.89 percent with 100% adherence
|
75.46 percent with 100% adherence
|
74.86 percent with 100% adherence
|
77.33 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
2 LifeWindows Visits (%)
|
80.36 percent with 100% adherence
|
82.48 percent with 100% adherence
|
81.50 percent with 100% adherence
|
85.53 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
3 LifeWindows Visits (%)
|
81.15 percent with 100% adherence
|
80.16 percent with 100% adherence
|
84.09 percent with 100% adherence
|
84.11 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
4 LifeWindows Visits (%)
|
79.92 percent with 100% adherence
|
81.78 percent with 100% adherence
|
80.11 percent with 100% adherence
|
81.58 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
5 LifeWindows Visits (%)
|
83.41 percent with 100% adherence
|
87.13 percent with 100% adherence
|
82.86 percent with 100% adherence
|
88.74 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
6 LifeWindows Visits (%)
|
81.25 percent with 100% adherence
|
82.46 percent with 100% adherence
|
81.61 percent with 100% adherence
|
83.55 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
7 LifeWindows Visits (%)
|
79.73 percent with 100% adherence
|
85.61 percent with 100% adherence
|
79.70 percent with 100% adherence
|
87.18 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
8 LifeWindows Visits (%)
|
79.82 percent with 100% adherence
|
88.54 percent with 100% adherence
|
79.00 percent with 100% adherence
|
91.76 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
9 LifeWindows Visits (%)
|
82.02 percent with 100% adherence
|
87.14 percent with 100% adherence
|
81.58 percent with 100% adherence
|
89.39 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
10 LifeWindows Visits (%)
|
69.12 percent with 100% adherence
|
80.70 percent with 100% adherence
|
71.93 percent with 100% adherence
|
84.62 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
11 LifeWindows Visits (%)
|
70.21 percent with 100% adherence
|
78.57 percent with 100% adherence
|
68.42 percent with 100% adherence
|
83.78 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
12 LifeWindows Visits (%)
|
78.13 percent with 100% adherence
|
90.63 percent with 100% adherence
|
73.08 percent with 100% adherence
|
88.46 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
13 LifeWindows Visits (%)
|
68.00 percent with 100% adherence
|
87.50 percent with 100% adherence
|
65.00 percent with 100% adherence
|
85.71 percent with 100% adherence
|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
14 LifeWindows Visits (%)
|
69.23 percent with 100% adherence
|
85.71 percent with 100% adherence
|
70.00 percent with 100% adherence
|
81.82 percent with 100% adherence
|
PRIMARY outcome
Timeframe: Measured at each clinical visit over 18 months of participationPopulation: Intent to treat included all participants with \>=2 adherence assessments; OP sample further restricted this sample to those with \>=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparisons replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.
This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated. See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77
Outcome measures
| Measure |
Control (ITT Sample %)
n=287 Participants
287 (94%) of the 304 randomized to control
|
Intervention (ITT Sample)
n=277 Participants
277 (96%) of the 290 randomized to Intervention condition
|
Control (On Protocol Sample)
n=176 Participants
176 (61%) of the ITT included control arm participants
|
Intervention (On Protocol)
n=152 Participants
152 (55%) of the ITT included intervention arm participants
|
|---|---|---|---|---|
|
Visual Analog Scale Measure of Adherence to ART
1 LifeWindows Visit (%)
|
42.61 percent with 100% adherence
|
46.15 percent with 100% adherence
|
45.71 percent with 100% adherence
|
45.33 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
2 LifeWindows Visits (%)
|
43.27 percent with 100% adherence
|
47.81 percent with 100% adherence
|
43.35 percent with 100% adherence
|
47.37 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
3 LifeWindows Visits (%)
|
42.69 percent with 100% adherence
|
47.77 percent with 100% adherence
|
42.05 percent with 100% adherence
|
49.67 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
4 LifeWindows Visits (%)
|
42.21 percent with 100% adherence
|
48.44 percent with 100% adherence
|
40.34 percent with 100% adherence
|
44.74 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
5 LifeWindows Visits (%)
|
42.79 percent with 100% adherence
|
50.99 percent with 100% adherence
|
41.14 percent with 100% adherence
|
50.99 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
6 LifeWindows Visits (%)
|
45.83 percent with 100% adherence
|
49.12 percent with 100% adherence
|
45.98 percent with 100% adherence
|
51.32 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
7 LifeWindows Visits (%)
|
41.89 percent with 100% adherence
|
41.67 percent with 100% adherence
|
40.60 percent with 100% adherence
|
46.15 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
8 LifeWindows Visits (%)
|
35.09 percent with 100% adherence
|
40.63 percent with 100% adherence
|
34.00 percent with 100% adherence
|
42.35 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
9 LifeWindows Visits (%)
|
31.46 percent with 100% adherence
|
38.57 percent with 100% adherence
|
30.26 percent with 100% adherence
|
39.39 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
10 LifeWindows Visits (%)
|
29.41 percent with 100% adherence
|
36.84 percent with 100% adherence
|
28.07 percent with 100% adherence
|
36.54 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
11 LifeWindows Visits (%)
|
27.66 percent with 100% adherence
|
30.95 percent with 100% adherence
|
23.68 percent with 100% adherence
|
29.73 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
12 LifeWindows Visits (%)
|
28.13 percent with 100% adherence
|
31.25 percent with 100% adherence
|
23.08 percent with 100% adherence
|
23.08 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
13 LifeWindows Visits (%)
|
28.00 percent with 100% adherence
|
41.67 percent with 100% adherence
|
25.00 percent with 100% adherence
|
33.33 percent with 100% adherence
|
|
Visual Analog Scale Measure of Adherence to ART
14 LifeWindows Visits (%)
|
23.08 percent with 100% adherence
|
42.86 percent with 100% adherence
|
10.00 percent with 100% adherence
|
27.27 percent with 100% adherence
|
SECONDARY outcome
Timeframe: Measured over 18 monthsViral load data extracted from medical records beginning 30 days prior to baseline.
Outcome measures
| Measure |
Control (ITT Sample %)
n=287 Participants
287 (94%) of the 304 randomized to control
|
Intervention (ITT Sample)
n=277 Participants
277 (96%) of the 290 randomized to Intervention condition
|
Control (On Protocol Sample)
176 (61%) of the ITT included control arm participants
|
Intervention (On Protocol)
152 (55%) of the ITT included intervention arm participants
|
|---|---|---|---|---|
|
Viral Load Count
Baseline to 3 months (%)
|
73.9 percentage with undetectable viral load
|
70.3 percentage with undetectable viral load
|
—
|
—
|
|
Viral Load Count
3-6 months (%)
|
70.3 percentage with undetectable viral load
|
77.0 percentage with undetectable viral load
|
—
|
—
|
|
Viral Load Count
6-9 months (%)
|
73.4 percentage with undetectable viral load
|
75.0 percentage with undetectable viral load
|
—
|
—
|
|
Viral Load Count
9-12 months (%)
|
76.1 percentage with undetectable viral load
|
76.8 percentage with undetectable viral load
|
—
|
—
|
|
Viral Load Count
12-15 months (%)
|
70.2 percentage with undetectable viral load
|
76.5 percentage with undetectable viral load
|
—
|
—
|
|
Viral Load Count
15-18 months (%)
|
74.5 percentage with undetectable viral load
|
79.3 percentage with undetectable viral load
|
—
|
—
|
POST_HOC outcome
Timeframe: Data collected at BaselineOutcome measures
| Measure |
Control (ITT Sample %)
n=328 Participants
287 (94%) of the 304 randomized to control
|
Intervention (ITT Sample)
n=266 Participants
277 (96%) of the 290 randomized to Intervention condition
|
Control (On Protocol Sample)
176 (61%) of the ITT included control arm participants
|
Intervention (On Protocol)
152 (55%) of the ITT included intervention arm participants
|
|---|---|---|---|---|
|
Percentage of Participants Unemployed and on Disability
% of participants Unemployed
|
67 percentage of participant
|
52 percentage of participant
|
—
|
—
|
|
Percentage of Participants Unemployed and on Disability
% of participants on Disability
|
55 percentage of participant
|
43 percentage of participant
|
—
|
—
|
Adverse Events
Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeffrey Fisher, Principal Investigator
Center for Health, Intervention & Prevention
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place