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Completed

NCT Number: NCT03794648

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

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.

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Key information

Conditions

HIV-infection/Aids Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Interactive Supervised Therapy (MIST)

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2019
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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