NCT03794648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

September 13, 2018

Last Update Submit

January 3, 2019

Conditions

HIV-infection/Aids

Keywords

mobile appHIV-infectionsmedication adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Percentage ART adherence (self-reported)

    Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit)

  • Percentage ART adherence (by pill count)

    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

    One-month follow-up visit, two-month follow-up visit(end of study visit)

  • Participants' perceptions on using MIST intervention

    two-month follow-up visit (end of the study visit)

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: Mobile Interactive Supervised Therapy (MIST)

Control Group

NO INTERVENTION

Interventions

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.

Intervention Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (1)

  • Pang Y, Molton JS, Ooi WT, Paton NI, He HG. Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 27;8(3):e15702. doi: 10.2196/15702.

    PMID: 32217500DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication Adherence

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

January 7, 2019

Study Start

February 13, 2018

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

January 7, 2019

Record last verified: 2019-01

Locations

SG(1)