Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

March 23, 2017 updated by: Jessica Haberer, MD, Massachusetts General Hospital

Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
    • Mbarara District
      • Mbarara, Mbarara District, Uganda
        • Mbarara Immune Suppression Syndrome(ISS) Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed SMS, real-time monitoring
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.
Device: Fixed 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.
Other Names:
  • Wisepill
Experimental: Triggered SMS, real-time monitoring
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.
Device: Triggered 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.
Other Names:
  • Wisepill
No Intervention: control
Real-time adherence monitoring only (no SMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
real time (for 9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV RNA Suppression
Time Frame: After month 9
HIV RNA suppression (<100 copies/ml) in each study arm
After month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Mbarara University of Science and Technology

Investigators

  • Principal Investigator: Jessica Haberer, MD, MS, Massachusetts General Hospital
  • Principal Investigator: Angella Musiimenta, PhD, Mbarara University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH100940-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be available at the end of the study upon request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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