Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957865
• Other study ID #: R34MH100940-01
• Status: Completed
• Phase: N/A
• First received: September 25, 2013
• Last updated: September 24, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adherence
• HIV/AIDS

Intervention

Device:
• SMS reminders, real-time adherence monitoring
SMS reminders will be sent to intervention arm A and B 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.

Locations

Country	Name	City	State
Uganda	Mbarara Immune Suppression Syndrome(ISS) Clinic	Mbarara	Mbarara District

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mechanism by which SMS impact adherence	Qualitative interviews will be conducted to understand the mechanisms by which SMS impact adherence (e.g., overcoming cognitive barriers, providing social support). All participants will have one interview at Month 3. The second interview will occur after the first 48+ hour gap in adherence between Months 4-9 (or at Month 9 if there is no 48+ hour gap in adherence).	Month 3 and between Months 4-9	No
Primary	Antiretroviral therapy (ART) adherence levels	Difference in adherence among the study arms	real time (for 9 months)	No
Secondary	HIV RNA suppression	Difference in percent of participants with HIV RNA suppression among the study arms	After months 3 and 9	No