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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV-infection/Aids

Intervention / Treatment
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* Behavioral: Mobile Interactive Supervised Therapy (MIST)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Behavioral: Mobile Interactive Supervised Therapy (MIST)<br>* 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.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile app, HIV-infections, medication adherence