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

HIV-infection/Aids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794648
• Other study ID #: 2017/00150
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-infection/Aids
• Infection

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one-month follow-up and two-month follow-up visits
Secondary	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	Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit)
Secondary	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	One-month follow-up visit, two-month follow-up visit(end of study visit)
Secondary	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.	One-month follow-up visit, two-month follow-up visit(end of study visit)
Secondary	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.	two-month follow-up visit (end of the study visit)