Health Behavior, HIV Antiretroviral Therapy (ART) Adherence
Conditions
Keywords
HIV, AIDS, Antiretroviral Medication Adherence
Brief summary
This study will develop and evaluate the efficacy of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals.
Detailed description
When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized. Participants in this \ 18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.
Interventions
BEHAVIORALLifeWindows Intervention Sessions
At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
OTHERControl
At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.
Sponsors
National Institute of Mental Health (NIMH)
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-infected * English-speaking * Currently receiving treatment at one of the participating sites * Currently receiving antiretroviral therapy
Exclusion criteria
* Marked cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | Measured at each clinical care visit over 18 months of participation | 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. |
| Visual Analog Scale Measure of Adherence to ART | Measured at each clinical visit over 18 months of participation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load Count | Measured over 18 months | Viral load data extracted from medical records beginning 30 days prior to baseline. |
Countries
United States
Participant flow
Recruitment details
HIV + patients were recruited via provider referral and notices about the study posted in five large HIV care clinics in Connecticut, USA.
Participants by arm
| Arm | Count |
|---|---|
| Control Participants will receive the control condition | 304 |
| Intervention Participants will receive the LifeWindows Intervention sessions | 290 |
| Total | 594 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baselined | Completed baseline, never placed on ARVs | 8 | 5 |
| Baselined | Completed baseline only | 9 | 8 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 2 participants | 5 participants | 3 participants |
| Age, Categorical Between 18 and 65 years | 174 participants | 323 participants | 149 participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 9 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 301 Participants | 585 Participants | 284 Participants |
| Age, Continuous | 47.28 years STANDARD_DEVIATION 8.01 | 47 years STANDARD_DEVIATION 8 | 46.76 years STANDARD_DEVIATION 8 |
| Gender Female | 72 participants | 138 participants | 66 participants |
| Gender Male | 104 participants | 190 participants | 86 participants |
| Region of Enrollment United States | 304 participants | 594 participants | 290 participants |
| Sex: Female, Male Female | 119 Participants | 229 Participants | 110 Participants |
| Sex: Female, Male Male | 185 Participants | 365 Participants | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 304 | 0 / 290 |
| serious Total, serious adverse events | 0 / 304 | 0 / 290 |
Outcome results
Primary
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
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.
Time frame: Measured at each clinical care visit over 18 months of participation
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 7 LifeWindows Visits (%) | 79.73 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 3 LifeWindows Visits (%) | 81.15 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 1 LifeWindows Visit (%) | 72.89 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 8 LifeWindows Visits (%) | 79.82 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 9 LifeWindows Visits (%) | 82.02 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 10 LifeWindows Visits (%) | 69.12 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 4 LifeWindows Visits (%) | 79.92 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 2 LifeWindows Visits (%) | 80.36 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 13 LifeWindows Visits (%) | 68.00 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 5 LifeWindows Visits (%) | 83.41 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 11 LifeWindows Visits (%) | 70.21 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 6 LifeWindows Visits (%) | 81.25 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 14 LifeWindows Visits (%) | 69.23 percent with 100% adherence |
| Control (ITT Sample %) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 12 LifeWindows Visits (%) | 78.13 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 12 LifeWindows Visits (%) | 90.63 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 1 LifeWindows Visit (%) | 75.46 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 7 LifeWindows Visits (%) | 85.61 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 5 LifeWindows Visits (%) | 87.13 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 8 LifeWindows Visits (%) | 88.54 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 3 LifeWindows Visits (%) | 80.16 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 10 LifeWindows Visits (%) | 80.70 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 2 LifeWindows Visits (%) | 82.48 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 9 LifeWindows Visits (%) | 87.14 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 14 LifeWindows Visits (%) | 85.71 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 6 LifeWindows Visits (%) | 82.46 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 13 LifeWindows Visits (%) | 87.50 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 11 LifeWindows Visits (%) | 78.57 percent with 100% adherence |
| Intervention (ITT Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 4 LifeWindows Visits (%) | 81.78 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 10 LifeWindows Visits (%) | 71.93 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 1 LifeWindows Visit (%) | 74.86 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 2 LifeWindows Visits (%) | 81.50 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 3 LifeWindows Visits (%) | 84.09 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 4 LifeWindows Visits (%) | 80.11 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 5 LifeWindows Visits (%) | 82.86 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 11 LifeWindows Visits (%) | 68.42 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 6 LifeWindows Visits (%) | 81.61 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 7 LifeWindows Visits (%) | 79.70 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 8 LifeWindows Visits (%) | 79.00 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 9 LifeWindows Visits (%) | 81.58 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 12 LifeWindows Visits (%) | 73.08 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 13 LifeWindows Visits (%) | 65.00 percent with 100% adherence |
| Control (On Protocol Sample) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 14 LifeWindows Visits (%) | 70.00 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 10 LifeWindows Visits (%) | 84.62 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 11 LifeWindows Visits (%) | 83.78 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 6 LifeWindows Visits (%) | 83.55 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 5 LifeWindows Visits (%) | 88.74 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 1 LifeWindows Visit (%) | 77.33 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 12 LifeWindows Visits (%) | 88.46 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 4 LifeWindows Visits (%) | 81.58 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 3 LifeWindows Visits (%) | 84.11 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 14 LifeWindows Visits (%) | 81.82 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 13 LifeWindows Visits (%) | 85.71 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 2 LifeWindows Visits (%) | 85.53 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 9 LifeWindows Visits (%) | 89.39 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 8 LifeWindows Visits (%) | 91.76 percent with 100% adherence |
| Intervention (On Protocol) | AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken | 7 LifeWindows Visits (%) | 87.18 percent with 100% adherence |
Comparison: For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.p-value: 0.12HLM
Comparison: For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.p-value: 0.024HLM
Primary
Visual Analog Scale Measure of Adherence to ART
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
Time frame: Measured at each clinical visit over 18 months of participation
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 9 LifeWindows Visits (%) | 31.46 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 8 LifeWindows Visits (%) | 35.09 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 5 LifeWindows Visits (%) | 42.79 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 14 LifeWindows Visits (%) | 23.08 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 7 LifeWindows Visits (%) | 41.89 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 6 LifeWindows Visits (%) | 45.83 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 12 LifeWindows Visits (%) | 28.13 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 1 LifeWindows Visit (%) | 42.61 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 3 LifeWindows Visits (%) | 42.69 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 13 LifeWindows Visits (%) | 28.00 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 11 LifeWindows Visits (%) | 27.66 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 10 LifeWindows Visits (%) | 29.41 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 4 LifeWindows Visits (%) | 42.21 percent with 100% adherence |
| Control (ITT Sample %) | Visual Analog Scale Measure of Adherence to ART | 2 LifeWindows Visits (%) | 43.27 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 11 LifeWindows Visits (%) | 30.95 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 1 LifeWindows Visit (%) | 46.15 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 2 LifeWindows Visits (%) | 47.81 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 3 LifeWindows Visits (%) | 47.77 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 4 LifeWindows Visits (%) | 48.44 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 5 LifeWindows Visits (%) | 50.99 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 6 LifeWindows Visits (%) | 49.12 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 7 LifeWindows Visits (%) | 41.67 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 8 LifeWindows Visits (%) | 40.63 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 9 LifeWindows Visits (%) | 38.57 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 10 LifeWindows Visits (%) | 36.84 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 12 LifeWindows Visits (%) | 31.25 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 13 LifeWindows Visits (%) | 41.67 percent with 100% adherence |
| Intervention (ITT Sample) | Visual Analog Scale Measure of Adherence to ART | 14 LifeWindows Visits (%) | 42.86 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 11 LifeWindows Visits (%) | 23.68 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 13 LifeWindows Visits (%) | 25.00 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 2 LifeWindows Visits (%) | 43.35 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 4 LifeWindows Visits (%) | 40.34 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 12 LifeWindows Visits (%) | 23.08 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 1 LifeWindows Visit (%) | 45.71 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 10 LifeWindows Visits (%) | 28.07 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 8 LifeWindows Visits (%) | 34.00 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 6 LifeWindows Visits (%) | 45.98 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 3 LifeWindows Visits (%) | 42.05 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 5 LifeWindows Visits (%) | 41.14 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 14 LifeWindows Visits (%) | 10.00 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 7 LifeWindows Visits (%) | 40.60 percent with 100% adherence |
| Control (On Protocol Sample) | Visual Analog Scale Measure of Adherence to ART | 9 LifeWindows Visits (%) | 30.26 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 7 LifeWindows Visits (%) | 46.15 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 8 LifeWindows Visits (%) | 42.35 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 13 LifeWindows Visits (%) | 33.33 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 9 LifeWindows Visits (%) | 39.39 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 3 LifeWindows Visits (%) | 49.67 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 10 LifeWindows Visits (%) | 36.54 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 2 LifeWindows Visits (%) | 47.37 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 11 LifeWindows Visits (%) | 29.73 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 14 LifeWindows Visits (%) | 27.27 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 12 LifeWindows Visits (%) | 23.08 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 5 LifeWindows Visits (%) | 50.99 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 1 LifeWindows Visit (%) | 45.33 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 6 LifeWindows Visits (%) | 51.32 percent with 100% adherence |
| Intervention (On Protocol) | Visual Analog Scale Measure of Adherence to ART | 4 LifeWindows Visits (%) | 44.74 percent with 100% adherence |
Comparison: For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.p-value: 0.12HLM
Comparison: For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.p-value: 0.12HLM
Secondary
Viral Load Count
Viral load data extracted from medical records beginning 30 days prior to baseline.
Time frame: Measured over 18 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (ITT Sample %) | Viral Load Count | Baseline to 3 months (%) | 73.9 percentage with undetectable viral load |
| Control (ITT Sample %) | Viral Load Count | 3-6 months (%) | 70.3 percentage with undetectable viral load |
| Control (ITT Sample %) | Viral Load Count | 6-9 months (%) | 73.4 percentage with undetectable viral load |
| Control (ITT Sample %) | Viral Load Count | 9-12 months (%) | 76.1 percentage with undetectable viral load |
| Control (ITT Sample %) | Viral Load Count | 12-15 months (%) | 70.2 percentage with undetectable viral load |
| Control (ITT Sample %) | Viral Load Count | 15-18 months (%) | 74.5 percentage with undetectable viral load |
| Intervention (ITT Sample) | Viral Load Count | 12-15 months (%) | 76.5 percentage with undetectable viral load |
| Intervention (ITT Sample) | Viral Load Count | Baseline to 3 months (%) | 70.3 percentage with undetectable viral load |
| Intervention (ITT Sample) | Viral Load Count | 9-12 months (%) | 76.8 percentage with undetectable viral load |
| Intervention (ITT Sample) | Viral Load Count | 3-6 months (%) | 77.0 percentage with undetectable viral load |
| Intervention (ITT Sample) | Viral Load Count | 15-18 months (%) | 79.3 percentage with undetectable viral load |
| Intervention (ITT Sample) | Viral Load Count | 6-9 months (%) | 75.0 percentage with undetectable viral load |
Comparison: For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p \> 0.50. The study was underpowered to detect differences in Viral load.p-value: >0.5Generalized Linear Model (GLM)
Post Hoc
Percentage of Participants Unemployed and on Disability
Time frame: Data collected at Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (ITT Sample %) | Percentage of Participants Unemployed and on Disability | % of participants Unemployed | 67 percentage of participant |
| Control (ITT Sample %) | Percentage of Participants Unemployed and on Disability | % of participants on Disability | 55 percentage of participant |
| Intervention (ITT Sample) | Percentage of Participants Unemployed and on Disability | % of participants Unemployed | 52 percentage of participant |
| Intervention (ITT Sample) | Percentage of Participants Unemployed and on Disability | % of participants on Disability | 43 percentage of participant |
Comparison: P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.p-value: <0.001Chi-squared
Comparison: P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.p-value: <0.01Chi-squared