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The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication

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ClinicalTrials.gov Identifier: NCT03794648
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV-infection/Aids Behavioral: Mobile Interactive Supervised Therapy (MIST) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 13, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group Behavioral: Mobile Interactive Supervised Therapy (MIST)
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.
No Intervention: Control Group


Outcome Measures
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Primary Outcome Measures :
  1. Change from one month percentage ART adherence at two months (by MEMScap) [ Time Frame: one-month follow-up and two-month follow-up visits ]
    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 :
  1. Percentage ART adherence (self-reported) [ Time Frame: Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit) ]
    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

  2. Percentage ART adherence (by pill count) [ Time Frame: One-month follow-up visit, two-month follow-up visit(end of study visit) ]
    Percentage adherence over the 2 month study period, as measured by pill count, collected at month 1 and 2 follow-up visits

  3. Variability in time (minutes) between prescribed pill time and actual dose taken [ Time Frame: One-month follow-up visit, two-month follow-up visit(end of study visit) ]
    Variability in time (minutes) between prescribed pill time and actual dose taken, as measured by MEMScaps, collected at the 1 and 2 month visits.

  4. Participants' perceptions on using MIST intervention [ Time Frame: two-month follow-up visit (end of the study visit) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794648


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03794648    
Other Study ID Numbers: 2017/00150
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
mobile app
HIV-infections
medication adherence
Additional relevant MeSH terms:
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Infections
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases