HIV-infection/AidsNCT03794648
The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication
A study testing Mobile Interactive Supervised Therapy (MIST) in people with HIV-infection/Aids, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV-infection/Aids
- What is being tested?
- Mobile Interactive Supervised Therapy (MIST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Feb 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- HIV-infection/Aids
- Being tested
- Mobile Interactive Supervised Therapy (MIST)
- Keywords
- mobile app, HIV-infections, medication adherence
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Interactive Supervised Therapy (MIST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Mobile Interactive Supervised Therapy (MIST) |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one-month follow-up and two-month follow-up visits
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: two-month follow-up visit (end of the study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start13 Feb 2018
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-infection/AidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794648
- Sponsor's protocol ID
- 2017/00150
- Other IDs
- 2017
- Status last verified
- Jan 2019
- First submitted
- 13 Sep 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32217500
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03794648
- Acronym / sponsor ID
- 2017/00150
- Conditions
- HIV-infection/Aids
- Keywords
- mobile app, HIV-infections, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mobile Interactive Supervised Therapy (MIST) |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
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.
4 secondary outcomes
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 ART adherence (by pill count)
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
Time frame: One-month follow-up visit, two-month follow-up visit(end of study visit)
Participants' perceptions on using MIST intervention
Time frame: two-month follow-up visit (end of the study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Derived from this study: PubMed 32217500Pang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Interactive Supervised Therapy (MIST) in people with HIV-infection/Aids, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from one month percentage ART adherence at two months (by MEMScap) (time frame: one-month follow-up and two-month follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.