Patient CompliancePhase 3AIMNCT01252212
Adherence, Improvement Measure (AIM) System
A Phase 3 study testing SMS medication adherence and No SMS adherence reminder in people with Patient Compliance and AIDS, run by University of California, San Francisco at 1 site in United States.
Trial summary
In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Compliance, AIDS
- What is being tested?
- SMS medication adherence and No SMS adherence reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2012
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18
- Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
- Detectable Viral Load, based on patient's medical record
- Receiving primary medical care at the AIDS Program at SFGH
- Able and willing to give informed consent to be randomized to study arms
- Willing to use the patient portal
- Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH
Who cannot join
- Failure to meet inclusion criteria
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Ward 86, San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101
In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.
- Conditions
- Patient Compliance, AIDS
- Being tested
- SMS medication adherence, No SMS adherence reminder
- Keywords
- HIV, antiretroviral, adherence, SMS, cell phone
- Medical subject headings
- Patient Compliance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS medication adherenceBehavioural
Also called mobile health messages for health conditions and medications
SMS messages to cell phones.
No SMS adherence reminderBehavioural
Also called No medication adherence or disease specific messages.
In this arm, patients will be sent supportive lifestyle suggestions to their phone using SMS technology but will not be sent a reminder regarding their medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Receiving SMS alerts | Experimental | The patients randomized to this arm will have a SMS message sent to them regarding medication adherence for antiretroviral medications, anti-hypertensive medications, anti-depressants, hyperglycemic controlling medications and hypercholesterolemia controlling medications as well as life style supportive suggestions. Receives: Behavioral: SMS medication adherence |
| No SMS messages | Active comparator | The patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions. Receives: Behavioral: No SMS adherence reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load
The primary analyses of the 12-month trial data will compare the two study groups with respect to (i) change from baseline in CD4 T-cell count; and (ii) proportion of patients whose HIV viral load (VL) level is detectable. We will use repeated-measures analysis techniques to estimate longitudinal prevalence at the population level (via generalized estimating equations) and at the individual levels (via generalized linear mixed models)[25].
Measured: 12 month
Secondary outcomes (1)
Level of antiretroviral medication in hair
We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- The Commonwealth Fund, National Institute of Mental Health (NIMH), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- James Kahn, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252212
- Sponsor's protocol ID
- 10-00019
- Other IDs
- 1RC1MH088341
- Acronym
- AIM
- Status last verified
- Nov 2013
- First submitted
- 30 Nov 2010
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101
- ClinicalTrials.gov ID
- NCT01252212
- Acronym / sponsor ID
- AIM / 10-00019
- Conditions
- Patient Compliance, AIDS
- Keywords
- HIV, antiretroviral, adherence, SMS, cell phone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- The Commonwealth Fund, National Institute of Mental Health (NIMH), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2010 (estimated)
- 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.
In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving SMS alerts | Experimental | Behavioral: SMS medication adherenceThe patients randomized to this arm will have a SMS message sent to them regarding medication adherence for antiretroviral medications, anti-hypertensive medications, anti-depressants, hyperglycemic controlling medications and hypercholesterolemia controlling medications as well as life style supportive suggestions. |
| No SMS messages | Active comparator | Behavioral: No SMS adherence reminderThe patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 18
- Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
- Detectable Viral Load, based on patient's medical record
- Receiving primary medical care at the AIDS Program at SFGH
- Able and willing to give informed consent to be randomized to study arms
Key exclusion criteria (2 listed)
- Failure to meet inclusion criteria
- -
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 |
|---|---|---|
| SMS medication adherenceAlso: mobile health messages for health conditions and medicationsSMS messages to cell phones. | Behavioural | Receiving SMS alerts |
| No SMS adherence reminderAlso: No medication adherence or disease specific messages.In this arm, patients will be sent supportive lifestyle suggestions to their phone using SMS technology but will not be sent a reminder regarding their medication adherence. | Behavioural | No SMS messages |
Primary outcome
HIV viral load
Time frame: 12 month
The primary analyses of the 12-month trial data will compare the two study groups with respect to (i) change from baseline in CD4 T-cell count; and (ii) proportion of patients whose HIV viral load (VL) level is detectable. We will use repeated-measures analysis techniques to estimate longitudinal prevalence at the population level (via generalized estimating equations) and at the individual levels (via generalized linear mixed models)[25].
1 secondary outcome
Level of antiretroviral medication in hair
Time frame: 12 month
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 20 Nov 2013.
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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.
James Kahn, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMS medication adherence and No SMS adherence reminder in people with Patient Compliance and AIDS, run by University of California, San Francisco at 1 site in United States.
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 7 inclusion and 2 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 20 Nov 2013. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HIV viral load (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2013.