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

Not Applicable

Completed

• Conditions: HIV-infection/Aids
• Interventions: Behavioral: Mobile Interactive Supervised Therapy (MIST)

• Registration Number: NCT03794648
• Lead Sponsor: National University Hospital, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2018-09-13
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-07
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Mobile Interactive Supervised Therapy (MIST)	-

Primary Outcome Measures

Name	Time	Method
Change from one month percentage ART adherence at two months (by MEMScap)	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

Name	Time	Method
Variability in time (minutes) between prescribed pill time and actual dose taken	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.
Percentage ART adherence (by pill count)	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
Participants' perceptions on using MIST intervention	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.
Percentage ART adherence (self-reported)	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

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore