HIV InfectionsPhase 2NCT00053443
Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens
A Phase 2 study testing Medication Reminder System/Adherence Tracker in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Medication Reminder System/Adherence Tracker
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2005
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV positive
- Currently taking medications for HIV/AIDS.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance Enhancement In HIV/AIDS Patients
While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly.
Read the detailed description
As the use of protease inhibitors and other antiretroviral medications has increased, multiple drug resistant HIV strains have emerged, demonstrating the need for improved patient adherence to complex drug regimens. Individual computerized adherence systems have been proposed as a mechanism for improving patient adherence. This study will utilize advanced computer and communication technologies to produce a handheld (PDA) product for HIV/AIDS patients. The system serves as a patient reminder system, addresses problems of missed medications, and monitors severity of side effects. This study will evaluate the efficacy of the system as an adherence intervention.
Participants in the study will be randomized to either the intervention or a control group. Participants will use the PDA daily for medication reminders, alarms, adherence tracking, and as a source of information on HIV/AIDS. The study will last 15 weeks. Each participant will have 6 study interviews and 2 quality control interviews. Study interviews will include adherence questionnaires, blood tests for viral load and CD4 data, and quality of life assessments.
- Conditions
- HIV Infections
- Being tested
- Medication Reminder System/Adherence Tracker
- Keywords
- Adherence, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Reminder System/Adherence TrackerDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2003 (estimated)
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 156 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053443
- Sponsor's protocol ID
- 2R44AI43750-02 A 2
- Other IDs
- 5R44AI043750-03
- Status last verified
- Dec 2005
- First submitted
- 29 Jan 2003
- Last updated
- 14 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance Enhancement In HIV/AIDS Patients
- ClinicalTrials.gov ID
- NCT00053443
- Acronym / sponsor ID
- 2R44AI43750-02 A 2
- Conditions
- HIV Infections
- Keywords
- Adherence, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 30 Jan 2003 (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.
While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly.
Detailed description
As the use of protease inhibitors and other antiretroviral medications has increased, multiple drug resistant HIV strains have emerged, demonstrating the need for improved patient adherence to complex drug regimens. Individual computerized adherence systems have been proposed as a mechanism for improving patient adherence. This study will utilize advanced computer and communication technologies to produce a handheld (PDA) product for HIV/AIDS patients. The system serves as a patient reminder system, addresses problems of missed medications, and monitors severity of side effects. This study will evaluate the efficacy of the system as an adherence intervention.
Participants in the study will be randomized to either the intervention or a control group. Participants will use the PDA daily for medication reminders, alarms, adherence tracking, and as a source of information on HIV/AIDS. The study will last 15 weeks. Each participant will have 6 study interviews and 2 quality control interviews. Study interviews will include adherence questionnaires, blood tests for viral load and CD4 data, and quality of life assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HIV positive
- Currently taking medications for HIV/AIDS.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Medication Reminder System/Adherence Tracker | Device | – |
Primary outcome
Not reported in the source record.
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 14 Dec 2016.
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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 Phase 2 study testing Medication Reminder System/Adherence Tracker in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 2 inclusion and 0 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 14 Dec 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 14 Dec 2016.