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Completed

NCT Number: NCT01957865

Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

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

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Key information

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Wisepill

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.

Other names: Wisepill

Primary outcomes

  1. 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%.

Secondary outcomes

  1. HIV RNA Suppression

    Time frame: After month 9

    HIV RNA suppression (<100 copies/ml) in each study arm

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Mbarara University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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