HIV/AIDS
Conditions
Keywords
Wisepill, ART, PLWH
Brief summary
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.
Detailed description
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.
Interventions
The Intervention group will receive the Wise app that delivers medication adherence reminders.
BEHAVIORALWise app with fitness reminders
The control group will receive the Wise app with fitness reminders
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of HIV * Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL * Be able to communicate and read in English or Spanish * Live in the US * Have a smartphone * Be taking ART medications
Exclusion criteria
* Participation in any other mobile app study for PLWH, including text messaging studies * Diagnosis of a clinical problem that would preclude someone from using a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ART Adherence - Clever Cap | Up to 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cluster of Differentiation 4 (CD4) Count | Baseline, 3 month follow up, and 6 month follow up | Using blood samples obtained during study visits, CD4 count will be used to asses ART adherence |
| Change in Viral Load | Baseline, 3 month follow up, and 6 month follow up | Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence. |
| Change in Score on the Center for Adherence Support Evaluation (CASE) Index | Baseline, 3 month follow up, and 6 month follow up | 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). |
| Change in Score on the Engagement With Health Care Provider Scale | Baseline, 3 months, and 6 months | 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. |
| Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | Baseline, 3 month follow up and 6 month follow up | 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. |
| Change in Number of Primary Care Visits | Baseline, 3 months, and 6 months | This will be measured by the self-reported number of primary care visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders | 101 |
| 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. | 97 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 19 |
| Overall Study | Withdrawal by PI | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 49.34 years STANDARD_DEVIATION 10.2 | 49.26 years STANDARD_DEVIATION 10.5 | 49.19 years STANDARD_DEVIATION 10.9 |
| Antiretroviral (ART) Adherence Visual Analog Scale | 71.76 units on a scale STANDARD_DEVIATION 26.14 | 69.37 units on a scale STANDARD_DEVIATION 26.43 | 66.84 units on a scale STANDARD_DEVIATION 26.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 51 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 147 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 146 Participants | 75 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 29 Participants | 12 Participants |
| Race (NIH/OMB) White | 8 Participants | 13 Participants | 5 Participants |
| Region of Enrollment United States | 101 Participants | 198 Participants | 97 Participants |
| Sex/Gender, Customized Female | 28 Participants | 83 Participants | 55 Participants |
| Sex/Gender, Customized Male | 67 Participants | 106 Participants | 39 Participants |
| Sex/Gender, Customized Other (Unspecified) | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Transgender Female | 4 Participants | 6 Participants | 2 Participants |
| Sex/Gender, Customized Transgender Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 99 |
| other Total, other adverse events | 0 / 101 | 0 / 99 |
| serious Total, serious adverse events | 0 / 101 | 0 / 99 |
Outcome results
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).
Time frame: Up to 6 months
Population: Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in ART Adherence - Clever Cap | 0.385 Times taking medication/day | Standard Deviation 0.487 |
| Intervention | Change in ART Adherence - Clever Cap | 0.445 Times taking medication/day | Standard Deviation 0.497 |
Comparison: Compares difference in adherence changes between Intervention and Control armsp-value: <0.000195% CI: [0.993, 0.995]Mixed Models Analysis
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
Time frame: Baseline, 3 month follow up, and 6 month follow up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Cluster of Differentiation 4 (CD4) Count | Baseline | 5.972 cells/mm^3 | Standard Deviation 1.102 |
| Control | Change in Cluster of Differentiation 4 (CD4) Count | 3-Month Follow-up | 5.811 cells/mm^3 | Standard Deviation 1.389 |
| Control | Change in Cluster of Differentiation 4 (CD4) Count | 6-Month Follow-up | 5.772 cells/mm^3 | Standard Deviation 1.341 |
| Intervention | Change in Cluster of Differentiation 4 (CD4) Count | Baseline | 6.060 cells/mm^3 | Standard Deviation 0.806 |
| Intervention | Change in Cluster of Differentiation 4 (CD4) Count | 3-Month Follow-up | 6.102 cells/mm^3 | Standard Deviation 0.838 |
| Intervention | Change in Cluster of Differentiation 4 (CD4) Count | 6-Month Follow-up | 5.974 cells/mm^3 | Standard Deviation 0.941 |
Secondary
Change in Number of Primary Care Visits
This will be measured by the self-reported number of primary care visits.
Time frame: Baseline, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Number of Primary Care Visits | 6-Month Follow-up | 1.208 primary care appointments | Standard Deviation 0.592 |
| Control | Change in Number of Primary Care Visits | Baseline | 1.153 primary care appointments | Standard Deviation 0.484 |
| Control | Change in Number of Primary Care Visits | 3-Month Follow-up | 1.207 primary care appointments | Standard Deviation 0.561 |
| Intervention | Change in Number of Primary Care Visits | Baseline | 1.084 primary care appointments | Standard Deviation 0.315 |
| Intervention | Change in Number of Primary Care Visits | 3-Month Follow-up | 1.111 primary care appointments | Standard Deviation 0.316 |
| Intervention | Change in Number of Primary Care Visits | 6-Month Follow-up | 1.24 primary care appointments | Standard Deviation 0.612 |
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).
Time frame: Baseline, 3 month follow up, and 6 month follow up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | Baseline | 9.099 score on a scale | Standard Deviation 3.129 |
| Control | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | 3-Month Follow-up | 10.667 score on a scale | Standard Deviation 3.458 |
| Control | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | 6-Month Follow-up | 10.714 score on a scale | Standard Deviation 3.268 |
| Intervention | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | Baseline | 8.557 score on a scale | Standard Deviation 2.926 |
| Intervention | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | 3-Month Follow-up | 10.099 score on a scale | Standard Deviation 3.345 |
| Intervention | Change in Score on the Center for Adherence Support Evaluation (CASE) Index | 6-Month Follow-up | 10.197 score on a scale | Standard Deviation 3.533 |
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.
Time frame: Baseline, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Score on the Engagement With Health Care Provider Scale | Baseline | 17.386 score on a scale | Standard Deviation 8.158 |
| Control | Change in Score on the Engagement With Health Care Provider Scale | 3-Month Follow-up | 16.607 score on a scale | Standard Deviation 6.429 |
| Control | Change in Score on the Engagement With Health Care Provider Scale | 6-Month Follow-up | 18.221 score on a scale | Standard Deviation 7.918 |
| Intervention | Change in Score on the Engagement With Health Care Provider Scale | Baseline | 18.186 score on a scale | Standard Deviation 8.121 |
| Intervention | Change in Score on the Engagement With Health Care Provider Scale | 3-Month Follow-up | 18.038 score on a scale | Standard Deviation 8.528 |
| Intervention | Change in Score on the Engagement With Health Care Provider Scale | 6-Month Follow-up | 18.039 score on a scale | Standard Deviation 8.589 |
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.
Time frame: Baseline, 3 month follow up and 6 month follow up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | Baseline | 2.053 score on a scale | Standard Deviation 0.871 |
| Control | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | 3-Month Follow-up | 1.807 score on a scale | Standard Deviation 0.734 |
| Control | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | 6-Month Follow-up | 1.861 score on a scale | Standard Deviation 0.959 |
| Intervention | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | Baseline | 2.044 score on a scale | Standard Deviation 0.95 |
| Intervention | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | 3-Month Follow-up | 1.762 score on a scale | Standard Deviation 0.826 |
| Intervention | Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | 6-Month Follow-up | 1.692 score on a scale | Standard Deviation 0.733 |
Secondary
Change in Viral Load
Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence.
Time frame: Baseline, 3 month follow up, and 6 month follow up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Viral Load | 3-Month Follow-up | 0.536 copies/ml | Standard Deviation 0.502 |
| Control | Change in Viral Load | Baseline | 0.634 copies/ml | Standard Deviation 0.484 |
| Control | Change in Viral Load | 6-Month Follow-up | 0.558 copies/ml | Standard Deviation 0.5 |
| Intervention | Change in Viral Load | 3-Month Follow-up | 0.444 copies/ml | Standard Deviation 0.5 |
| Intervention | Change in Viral Load | Baseline | 0.567 copies/ml | Standard Deviation 0.498 |
| Intervention | Change in Viral Load | 6-Month Follow-up | 0.5 copies/ml | Standard Deviation 0.503 |