Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH066684 | U.S. NIH Grant/Contract | View source | |
| DAHBR 9A-ASPG |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Participants will receive the control condition |
|
| Intervention | Experimental | Participants will receive the LifeWindows Intervention sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifeWindows Intervention Sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at each clinical care visit over 18 months of participation |
| 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 | Measured at each clinical visit over 18 months of participation |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load Count | Viral load data extracted from medical records beginning 30 days prior to baseline. | Measured over 18 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey D. Fisher, PhD | University of Connecticut | Principal Investigator |
| K. Rivet Amico*, PhD | University of Connecticut (*co-PI) | Principal Investigator |
| Deborah H. Cornman*, PhD | University of Connecticut (*co-PI) | Principal Investigator |
| William A. Fisher*, PhD | University of Western Ontario (*co-PI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030-3212 | United States | ||
| Hartford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21452051 | Result | Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, Redding C, Barta W, Lemieux AF, Altice FL, Dieckhaus K, Friedland G; LifeWindows Team. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav. 2011 Nov;15(8):1635-46. doi: 10.1007/s10461-011-9926-x. |
| Label | URL |
|---|---|
| PubMed record of results article | View source |
Not provided
Not provided
HIV + patients were recruited via provider referral and notices about the study posted in five large HIV care clinics in Connecticut, USA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants will receive the control condition |
| FG001 | Intervention | Participants will receive the LifeWindows Intervention sessions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baselined |
|
| |||||||||||||||||||||
| Intention to Treat Sample |
| ||||||||||||||||||||||
| On Protocol Sample |
|
Baseline characteristics provided for randomized sample. Analyses were conducted on those with >=2 adherence assessments for ITT.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants will receive the control condition |
| BG001 | Intervention | Participants will receive the LifeWindows Intervention sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Intent to Treat (ITT) Sample |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percent with 100% adherence | Measured at each clinical care visit over 18 months of participation |
Patient enrollment to end of IRB annual renewals
No adverse events occurred during the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants will receive the control condition |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Fisher, Principal Investigator | Center for Health, Intervention & Prevention | (860) 486-4940 | jeffrey.fisher@uconn.edu |
Not provided
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control | Other | 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. |
|
| Hartford |
| Connecticut |
| 06102 |
| United States |
| Yale-New Haven Hospital Nathan Smith Clinic | New Haven | Connecticut | 06510 | United States |
| Hospital of Saint Raphael | New Haven | Connecticut | 06511 | United States |
| Waterbury Hospital | Waterbury | Connecticut | 06708 | United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Categorical | On Protocol (OP) The On-Protocol sample was derived from the ITT sample who also had completed >=6 assessments and had no ART receipt interruptions. | Number | participants |
|
| Age, Continuous | Intent to Treat (ITT) Sample | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Intent to Treat (ITT) Sample | Count of Participants | Participants |
|
| Gender | On Protocol (OP) | Number | participants |
|
| Region of Enrollment | Intent to Treat (ITT) Sample | Number | participants |
|
|
|
|
|
| Secondary | Viral Load Count | Viral load data extracted from medical records beginning 30 days prior to baseline. | Posted | Number | percentage with undetectable viral load | Measured over 18 months |
|
|
|
|
| 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 | 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. | Posted | Number | percent with 100% adherence | Measured at each clinical visit over 18 months of participation |
|
|
|
|
| Post-Hoc | Percentage of Participants Unemployed and on Disability | Posted | Number | percentage of participant | Data collected at Baseline |
|
|
|
|
| 0 |
| 304 |
| 0 |
| 304 |
| EG001 | Intervention | Participants will receive the LifeWindows Intervention sessions | 0 | 290 | 0 | 290 |
Not provided
Not provided
| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 6-9 months (%) |
|
| 9-12 months (%) |
|
| 12-15 months (%) |
|
| 15-18 months (%) |
|
| 2 LifeWindows Visits (%) |
|
| 3 LifeWindows Visits (%) |
|
| 4 LifeWindows Visits (%) |
|
| 5 LifeWindows Visits (%) |
|
| 6 LifeWindows Visits (%) |
|
| 7 LifeWindows Visits (%) |
|
| 8 LifeWindows Visits (%) |
|
| 9 LifeWindows Visits (%) |
|
| 10 LifeWindows Visits (%) |
|
| 11 LifeWindows Visits (%) |
|
| 12 LifeWindows Visits (%) |
|
| 13 LifeWindows Visits (%) |
|
| 14 LifeWindows Visits (%) |
|
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. |
| HLM |
| 0.12 |
The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed. |
| 95 |
| No |
| Superiority or Other |
| Chi-squared |
| <0.01 |
| 95 |
| No |
| Superiority or Other |