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| Name | Class |
|---|---|
| Mbarara University of Science and Technology | OTHER |
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Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed SMS, real-time monitoring | Experimental | SMS will be sent daily for one month, then weekly for two months. Participants will have real-time adherence monitoring and social supporters will be notified of gaps in adherence of 48+ hours in the last six months of the study. |
|
| Triggered SMS, real-time monitoring | Experimental | Participants will have real-time adherence monitoring and social supporters will be notified of gaps in adherence of 48+ hours in the last six months of the study. |
|
| control | No Intervention | Real-time adherence monitoring only (no SMS) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed SMS, real-time monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | real time (for 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| HIV RNA Suppression | HIV RNA suppression (<100 copies/ml) in each study arm | After month 9 |
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Wisepill Participants:
Inclusion Criteria:
Exclusion Criteria:
Social supporters (i.e., recipients of the SMS notifications for Wisepill participants in the intervention arms):
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Haberer, MD, MS | Massachusetts General Hospital | Principal Investigator |
| Angella Musiimenta, PhD | Mbarara University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara Immune Suppression Syndrome(ISS) Clinic | Mbarara | Mbarara District | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30626191 | Derived | Musiimenta A, Atukunda EC, Tumuhimbise W, Haberer JE. Resilience after withdrawing a technology-based medication adherence support intervention from people living with HIV in rural Uganda. AIDS Care. 2018 Aug;30(sup5):S89-S96. doi: 10.1080/09540121.2018.1510107. Epub 2019 Jan 9. | |
| 29773527 | Derived | Musiimenta A, Atukunda EC, Tumuhimbise W, Pisarski EE, Tam M, Wyatt MA, Ware NC, Haberer JE. Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 May 17;6(5):e122. doi: 10.2196/mhealth.9031. |
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De-identified data will be available at the end of the study upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control | Real-time adherence monitoring only (no SMS) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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%. | The participant found to be HIV negative was not included in the analysis. | Posted | Mean | Standard Deviation | Percent adherence | real time (for 9 months) |
|
1 year, 9 months
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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 | Fixed SMS, Real-time Monitoring | SMS were sent daily for one month, then weekly for two months. 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. Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Haberer | Massachusetts General Hospital | 617 724 0351 | jhaberer@partners.org |
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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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|
|
| Triggered SMS, real-time monitoring | Device | 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. |
|
|
| 26760452 | Derived | Haberer JE, Musiimenta A, Atukunda EC, Musinguzi N, Wyatt MA, Ware NC, Bangsberg DR. Short message service (SMS) reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016 May 15;30(8):1295-300. doi: 10.1097/QAD.0000000000001021. |
| 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. |
| BG002 | Control | Real-time adherence monitoring only (no SMS) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Median CD4 count | Median | Inter-Quartile Range | cells/mm^3 |
|
| OG001 | Triggered SMS, Real-time Monitoring | Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. 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. The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence. |
| OG002 | Control | Real-time adherence monitoring only (no SMS) |
|
|
|
| Secondary | HIV RNA Suppression | HIV RNA suppression (<100 copies/ml) in each study arm | Note: Missing data equals lack of suppression. The participant found to be HIV negative was not included in the analysis. | Posted | Number | number of participants | After month 9 |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Triggered SMS, Real-time Monitoring | 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. Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence. | 0 | 20 | 0 | 20 |
| EG002 | Control | Real-time adherence monitoring only (no SMS) | 0 | 22 | 0 | 22 |
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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 |