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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS025071 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.
Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, the investigators propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. This study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | WiseApp that delivers fitness reminders |
|
| Intervention | Experimental | WiseApp that delivers medication adherence reminders |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wise app with medication adherence reminders | Behavioral | The Intervention group will receive the Wise app that delivers medication adherence reminders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ART Adherence - Clever Cap | The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on the Center for Adherence Support Evaluation (CASE) Index | The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings. Items are scored such that higher values indicate better adherence, minimum score is 3 and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's α= 0.79). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, RN | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37747318 | Derived | Alvarez G, Sanabria G, Jia H, Cho H, Reynolds NR, Gradilla M, Olender S, Mohr DC, Schnall R. Do Walk Step Reminders Improve Physical Activity in Persons Living With HIV in New York City?-Results From a Randomized Clinical Trial. J Assoc Nurses AIDS Care. 2023 Nov-Dec 01;34(6):527-537. doi: 10.1097/JNC.0000000000000427. Epub 2023 Sep 25. | |
| 37707942 | Derived | Sanabria G, Bushover B, Ashrafnia S, Cordoba E, Schnall R. Understanding Physical Activity Determinants in an HIV Self-Management Intervention: Qualitative Analysis Guided by the Theory of Planned Behavior. JMIR Form Res. 2023 Sep 14;7:e47666. doi: 10.2196/47666. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | WiseApp that delivers fitness reminders Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders |
| FG001 | Intervention | WiseApp that delivers medication adherence reminders Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | WiseApp that delivers fitness reminders Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders |
| BG001 | Intervention | WiseApp that delivers medication adherence reminders Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is in years |
| 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 | Change in ART Adherence - Clever Cap | The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day). | Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. | Posted | Mean | Standard Deviation | Times taking medication/day | Up to 6 months |
|
Baseline to 6 months
All 200 participants were included in the adverse events analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | WiseApp that delivers fitness reminders Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schnall, PhD, MPH | Columbia University | 212-342-6886 | rb897@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2021 | Aug 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Wise app with fitness reminders | Behavioral | The control group will receive the Wise app with fitness reminders |
|
| Baseline, 3 month follow up, and 6 month follow up |
| Change in Cluster of Differentiation 4 (CD4) Count | Using blood samples obtained during study visits, CD4 count will be used to asses ART adherence | Baseline, 3 month follow up, and 6 month follow up |
| Change in Viral Load | Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence. | Baseline, 3 month follow up, and 6 month follow up |
| Change in Number of Primary Care Visits | This will be measured by the self-reported number of primary care visits. | Baseline, 3 months, and 6 months |
| Change in Score on the Engagement With Health Care Provider Scale | The Engagement with Health Care Provider 13-item Scale will be administered over the course of the trial to evaluate how participants' engagement with their health care providers changes their health care access overall. Items are scored such that higher scores indicate a more negative relationship with their health care provider. The minimum total score is 13 and the maximum total score is 52. | Baseline, 3 months, and 6 months |
| Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | Technology Acceptance: Perceived Ease of Use and Potential Usefulness 14-item Questionnaire provides a method for assessing participants' perception of the usefulness of the technology. Items are scored such that higher values indicate more positive perception. The minimum total score is 0 and the maximum total score is 70. | Baseline, 3 month follow up and 6 month follow up |
| 33238931 | Derived | Flynn G, Jia H, Reynolds NR, Mohr DC, Schnall R. Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). BMC Public Health. 2020 Nov 25;20(1):1775. doi: 10.1186/s12889-020-09688-0. |
| 32779730 | Derived | Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680. |
| Withdrawal by PI |
|
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Participants' reported gender identity regardless of sex at birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Antiretroviral (ART) Adherence Visual Analog Scale | This visual analog scale asked participants to indicate percentage of ART medications taken in the past 30 days on a scale ranging from 0 to 100 with higher values indicating more adherence. One participant in control group did not provide baseline data for this measure. | One participant in control group did not provide baseline data for this measure. | Mean | Standard Deviation | units on a scale |
|
WiseApp that delivers medication adherence reminders Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders. |
|
|
|
| Secondary | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings. Items are scored such that higher values indicate better adherence, minimum score is 3 and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's α= 0.79). | Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were corona virus disease (COVID-19) restrictions in place. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month follow up, and 6 month follow up |
|
|
|
| Secondary | Change in Cluster of Differentiation 4 (CD4) Count | Using blood samples obtained during study visits, CD4 count will be used to asses ART adherence | The number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, 3 month follow up, and 6 month follow up |
|
|
|
| Secondary | Change in Viral Load | Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence. | Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place. | Posted | Mean | Standard Deviation | copies/ml | Baseline, 3 month follow up, and 6 month follow up |
|
|
|
| Secondary | Change in Number of Primary Care Visits | This will be measured by the self-reported number of primary care visits. | The number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place. | Posted | Mean | Standard Deviation | primary care appointments | Baseline, 3 months, and 6 months |
|
|
|
| Secondary | Change in Score on the Engagement With Health Care Provider Scale | The Engagement with Health Care Provider 13-item Scale will be administered over the course of the trial to evaluate how participants' engagement with their health care providers changes their health care access overall. Items are scored such that higher scores indicate a more negative relationship with their health care provider. The minimum total score is 13 and the maximum total score is 52. | Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months |
|
|
|
| Secondary | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | Technology Acceptance: Perceived Ease of Use and Potential Usefulness 14-item Questionnaire provides a method for assessing participants' perception of the usefulness of the technology. Items are scored such that higher values indicate more positive perception. The minimum total score is 0 and the maximum total score is 70. | Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month follow up and 6 month follow up |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Intervention | WiseApp that delivers medication adherence reminders Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders. | 0 | 99 | 0 | 99 | 0 | 99 |
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| 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 |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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