The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication
Primary Purpose
HIV-infection/Aids
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mobile Interactive Supervised Therapy (MIST)
Sponsored by
About this trial
This is an interventional supportive care trial for HIV-infection/Aids focused on measuring mobile app, HIV-infections, medication adherence
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 21
- HIV infection diagnosis confirmed by western blot
- Taking a once daily regimen of HIV medications
- Able to take pills orally
- Willing and able to give informed consent
Exclusion Criteria:
- Inability to operate a smart phone
- Active Tuberculosis infection requiring treatment during study (due to additional challenge posed to adherence that may confound the assessment of HIV adherence)
- Substance use
- Visual or hearing impairment
- Cognitive impairment
Sites / Locations
- National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Change from one month percentage ART adherence at two months (by MEMScap)
Change percentage ART adherence over the 2 month study period, as measured by MEMScaps, collected at the 1 and 2 month visits.
Secondary Outcome Measures
Percentage ART adherence (self-reported)
Percentage self-reported adherence over a 21 day period (summation of the 7 days preceding each study visit) as measured by a standardised questionnaire at each study visit
Percentage ART adherence (by pill count)
Percentage adherence over the 2 month study period, as measured by pill count, collected at month 1 and 2 follow-up visits
Variability in time (minutes) between prescribed pill time and actual dose taken
Variability in time (minutes) between prescribed pill time and actual dose taken, as measured by MEMScaps, collected at the 1 and 2 month visits.
Participants' perceptions on using MIST intervention
Participants' perception of MIST intervention , assessed at the 2 month visit by a sei-structured interview. The interview mainly addressed five areas namely: perception of overall MIST app use experience, perceived usefulness of each feature, strengths and weakness of MIST, interest in continued to use MIST for future and recommendations for further improvements.
Full Information
NCT ID
NCT03794648
First Posted
September 13, 2018
Last Updated
January 3, 2019
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03794648
Brief Title
The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication
Official Title
The Feasibility and Preliminary Efficacy of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Medication Adherence of Patients With HIV Infection: a Pilot Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A total of 40 HIV infected patients will be randomly assigned into intervention or control group. Participants in the intervention group will use an smart phone application for two months. Participants will receive reminder notifications and use the app to take and send videos of themselves taking the pill(s), uploaded videos will be centrally reviewed by a study nurse . Control group participants will receive standard care. Antiretroviral Therapy adherence will be measured by self-report, pill count, and smart bottle as well as the App. Participants' perceptions of app using experience will be recorded via face to face interview.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection/Aids
Keywords
mobile app, HIV-infections, medication adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mobile Interactive Supervised Therapy (MIST)
Intervention Description
MIST system will send a reminder notification (via push or SMS) to participants 10 to 15 minutes before the scheduled time for taking their medication. Participants will then activate the recording function of the MIST app on their phone, and record themselves taking their medication.Participants will be asked to go through a series of steps for recording the video.
Primary Outcome Measure Information:
Title
Change from one month percentage ART adherence at two months (by MEMScap)
Description
Change percentage ART adherence over the 2 month study period, as measured by MEMScaps, collected at the 1 and 2 month visits.
Time Frame
one-month follow-up and two-month follow-up visits
Secondary Outcome Measure Information:
Title
Percentage ART adherence (self-reported)
Description
Percentage self-reported adherence over a 21 day period (summation of the 7 days preceding each study visit) as measured by a standardised questionnaire at each study visit
Time Frame
Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit)
Title
Percentage ART adherence (by pill count)
Description
Percentage adherence over the 2 month study period, as measured by pill count, collected at month 1 and 2 follow-up visits
Time Frame
One-month follow-up visit, two-month follow-up visit(end of study visit)
Title
Variability in time (minutes) between prescribed pill time and actual dose taken
Description
Variability in time (minutes) between prescribed pill time and actual dose taken, as measured by MEMScaps, collected at the 1 and 2 month visits.
Time Frame
One-month follow-up visit, two-month follow-up visit(end of study visit)
Title
Participants' perceptions on using MIST intervention
Description
Participants' perception of MIST intervention , assessed at the 2 month visit by a sei-structured interview. The interview mainly addressed five areas namely: perception of overall MIST app use experience, perceived usefulness of each feature, strengths and weakness of MIST, interest in continued to use MIST for future and recommendations for further improvements.
Time Frame
two-month follow-up visit (end of the study visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 21
HIV infection diagnosis confirmed by western blot
Taking a once daily regimen of HIV medications
Able to take pills orally
Willing and able to give informed consent
Exclusion Criteria:
Inability to operate a smart phone
Active Tuberculosis infection requiring treatment during study (due to additional challenge posed to adherence that may confound the assessment of HIV adherence)
Substance use
Visual or hearing impairment
Cognitive impairment
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32217500
Citation
Pang Y, Molton JS, Ooi WT, Paton NI, He HG. Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 27;8(3):e15702. doi: 10.2196/15702.
Results Reference
derived
Learn more about this trial
The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication
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