NCT01957865

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 10, 2016

Completed
Last Updated

May 3, 2017

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

September 25, 2013

Results QC Date

April 5, 2016

Last Update Submit

March 23, 2017

Conditions

HIV/AIDSAdherence

Keywords

HIV/AIDSadherencereal time monitoringSMSmHealthsocial support

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • HIV RNA Suppression

    After month 9

Study Arms (3)

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.

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.

Device: Triggered SMS, real-time monitoring

control

NO INTERVENTION

Real-time adherence monitoring only (no SMS)

Interventions

Fixed SMS, real-time monitoringDEVICE

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.

Also known as: Wisepill
Fixed SMS, real-time monitoring
Triggered SMS, real-time monitoringDEVICE

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.

Also known as: Wisepill
Triggered SMS, real-time monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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):
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara Immune Suppression Syndrome(ISS) Clinic

Mbarara, Mbarara District, Uganda

Location

Related Publications (3)

  • 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.

    PMID: 30626191DERIVED

  • 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.

    PMID: 29773527DERIVED

  • 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.

    PMID: 26760452DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Jessica Haberer
Organization
Massachusetts General Hospital
jhaberer@partners.org
617 724 0351

Study Officials

  • Jessica Haberer, MD, MS

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Angella Musiimenta, PhD

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 25, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 3, 2017

Results First Posted

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

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

Locations

UG(1)