N/A
N=63
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
HIV/AIDS · Adherence
Bottom Line
View on ClinicalTrials.gov: NCT01957865 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Antiretroviral Therapy (ART) Adherence Levels — 91; 79; 79 Percent adherence — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fixed SMS, real-time monitoring (Device); Triggered SMS, real-time monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antiretroviral Therapy (ART) Adherence Levels |
91; 79; 79 | <0.05 sig |
| SECONDARY HIV RNA Suppression |
20; 15; 19 | <0.05 sig |
Summary
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01957865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.