HIV/AIDSNCT01957865
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
A study testing Fixed SMS, real-time monitoring and Triggered SMS, real-time monitoring in people with HIV/AIDS and Adherence, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Fixed SMS, real-time monitoring and Triggered SMS, real-time monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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
Who cannot join
- 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):
- Unable to use SMS
- Unwilling to receive SMS notifications regarding interruptions in the intervention participant's adherence
- Severe mental condition limiting the ability to provide consent
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mbarara Immune Suppression Syndrome(ISS) Clinic
Mbarara, Mbarara District
About this study
Official title: Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
Read the 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.
- Being tested
- Fixed SMS, real-time monitoring, Triggered SMS, real-time monitoring
- Keywords
- HIV/AIDS, adherence, real time monitoring, SMS, mHealth, social support
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed SMS, real-time monitoringDevice
Also called Wisepill
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.
Triggered SMS, real-time monitoringDevice
Also called Wisepill
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fixed SMS, real-time monitoring |
| 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. Receives: Device: Triggered SMS, real-time monitoring |
| control | No intervention | Real-time adherence monitoring only (no SMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: real time (for 9 months)
Secondary outcomes (1)
HIV RNA Suppression
HIV RNA suppression (<100 copies/ml) in each study arm
Measured: After month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Jessica Haberer, MD, Massachusetts General Hospital
- Investigators
- Jessica Haberer, MD, MS, Principal investigator, Massachusetts General HospitalAngella Musiimenta, PhD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957865
- Sponsor's protocol ID
- R34MH100940-01
- Status last verified
- Nov 2016
- First submitted
- 25 Sep 2013
- Last updated
- 3 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be available at the end of the study upon request.
Publications
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.
PubMed 30626191Musiimenta 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.
PubMed 29773527Haberer 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.
PubMed 26760452
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
- ClinicalTrials.gov ID
- NCT01957865
- Acronym / sponsor ID
- R34MH100940-01
- Keywords
- HIV/AIDS, adherence, real time monitoring, SMS, mHealth, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 10 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fixed SMS, real-time monitoring | Experimental | Device: Fixed SMS, real-time monitoringSMS 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 | Device: Triggered SMS, real-time monitoringParticipants 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (8 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed SMS, real-time monitoringAlso: WisepillSMS 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. | Device | Fixed SMS, real-time monitoring |
| Triggered SMS, real-time monitoringAlso: WisepillSMS 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. | Device | Triggered SMS, real-time monitoring |
Primary outcome
Antiretroviral Therapy (ART) Adherence Levels
Time frame: 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%.
1 secondary outcome
HIV RNA Suppression
Time frame: After month 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30626191Musiimenta 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.
- Derived from this study: PubMed 29773527Musiimenta 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.
- Derived from this study: PubMed 26760452Haberer 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.
- Individual participant dataSharing planned: Yes. De-identified data will be available at the end of the study upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Haberer, MD, MS principal investigator
Massachusetts General Hospital
Angella Musiimenta, PhD principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed SMS, real-time monitoring and Triggered SMS, real-time monitoring in people with HIV/AIDS and Adherence, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral Therapy (ART) Adherence Levels (time frame: real time (for 9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957865, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.