Adherence, HIV/AIDS
Conditions
Keywords
HIV/AIDS, adherence, real time monitoring, SMS, mHealth, social support
Brief summary
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
Detailed description
In this study, the investigators propose to develop a real-time adherence intervention based on SMS (i.e., text messages), wireless adherence monitoring (with the Wisepill device), and engagement of social support that is tailored to rural sub-Saharan Africa. The investigators will build on research by others who have shown SMS reminders improve adherence and viral suppression in Kenya, albeit with relatively small effect sizes and suboptimal virologic failure rates even in the intervention arm. Moreover, little is known about which patients benefit from SMS, why they benefit, and what can be done to further improve adherence and treatment success rates. Understanding the mechanisms of effect will make it possible to design and test evidence-based interventions with the highest likelihood for efficacy. In a cohort of HIV-infected individuals starting ART and being monitored with Wisepill, the investigators will test 1) daily SMS reminders, 2) weekly SMS reminders, 3) SMS reminders linked to real-time detection of missed doses, and 4) SMS reminders plus SMS notifications of 48+hour gaps in adherence to members of social support networks. The investigators will conduct qualitative interviews to learn the experiences of participants and members of their social support networks with the different types of SMS. This staged approach will allow us to fully understand and compare the additive effects and acceptability of SMS-based interventions. The investigators will also determine behavioral effect mechanisms, as well as compare the impact of each type of SMS with a control population receiving only Wisepill monitoring on adherence and HIV RNA.
Interventions
DEVICEFixed SMS, real-time monitoring
SMS reminders will be sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.
DEVICETriggered SMS, real-time monitoring
SMS reminders will be sent as needed for missed doses to encourage adherence. The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.
Sponsors
Mbarara University of Science and Technology
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Wisepill Participants: Inclusion Criteria: * HIV-infected * Initiating ART within the next two weeks * Age 18 years and older * Owns a cell phone for personal use and has reliable cellular phone reception at home on a network supported by the technology used in this study * Lives in the Mbarara District (i.e, within 20 km of the ISS Clinic) * Has at least one person who could be named as a social supporter(see criteria below).
Exclusion criteria
* Unable to use SMS * Unwilling to receive SMS reminders * Severe mental condition limiting the ability to provide consent * Cellular phone reception is not reliable Social supporters (i.e., recipients of the SMS notifications for Wisepill participants in the intervention arms): Inclusion criteria: * Knows Wisepill participant has HIV * Age 18 years or older * Reports having provided social support to the intervention participant at least once * Own a cell phone for personal use and have reliable cellular phone reception at home on a network supported by the technology used in this study * Lives in the Mbarara District
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Therapy (ART) Adherence Levels | real time (for 9 months) | ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV RNA Suppression | After month 9 | HIV RNA suppression (\<100 copies/ml) in each study arm |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fixed SMS, Real-time Monitoring SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study. | 21 |
| Triggered SMS, Real-time Monitoring SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study. | 20 |
| Control Real-time adherence monitoring only (no SMS) | 22 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Found HIV negative | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Fixed SMS, Real-time Monitoring | Triggered SMS, Real-time Monitoring | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 33 years | 33 years | 27 years | 30 years |
| Median CD4 count | 309 cells/mm^3 | 291 cells/mm^3 | 382 cells/mm^3 | 309 cells/mm^3 |
| Region of Enrollment Uganda | 21 participants | 20 participants | 22 participants | 63 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 3 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 0 / 22 |
Outcome results
Primary
Antiretroviral Therapy (ART) Adherence Levels
ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.
Time frame: real time (for 9 months)
Population: The participant found to be HIV negative was not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed SMS, Real-time Monitoring | Antiretroviral Therapy (ART) Adherence Levels | 91 Percent adherence | Standard Deviation 9 |
| Triggered SMS, Real-time Monitoring | Antiretroviral Therapy (ART) Adherence Levels | 79 Percent adherence | Standard Deviation 18 |
| Control | Antiretroviral Therapy (ART) Adherence Levels | 79 Percent adherence | Standard Deviation 22 |
Comparison: In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.p-value: <0.05Linear and Poisson regressions
Secondary
HIV RNA Suppression
HIV RNA suppression (\<100 copies/ml) in each study arm
Time frame: After month 9
Population: Note: Missing data equals lack of suppression. The participant found to be HIV negative was not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fixed SMS, Real-time Monitoring | HIV RNA Suppression | 20 number of participants |
| Triggered SMS, Real-time Monitoring | HIV RNA Suppression | 15 number of participants |
| Control | HIV RNA Suppression | 19 number of participants |
Comparison: HIV RNA suppression (\<100 copies/ml) was compared among study arms by Fisher's exact test.p-value: <0.05Fisher's exact test