HIV InfectionMAPNCT00870792
Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
A study testing Adherence report in people with HIV Infection and HIV Infections, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- Adherence report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on ART
- willing to use MEMS cap
- speaks and reads English
- detectable viral loads
Who cannot join
- uses a pill box
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.
- Conditions
- HIV Infection, HIV Infections
- Being tested
- Adherence report
- Keywords
- HIV, antiretroviral therapy, medication adherence, Treatment Experienced
- Medical subject headings
- HIV Infections, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence reportBehavioural
During the intervention phase, the data collected at the study visit were summarized in a 3-page report that was given to the provider before each intervention visit. The report included data on self-reported adherence, MEMS adherence, reminder use, beliefs about ART, reasons for missed doses, alcohol and drug use, and depression.
| Study group | Role | What they receive |
|---|---|---|
| Received report | Active comparator | Not described Receives: Behavioral: Adherence report |
| Routine care | Placebo comparator | Patients receive usual, routine, care. Receives: Behavioral: Adherence report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral medication adherence as assessed by electronic pill cap monitoring.
Measured: 6 months
Secondary outcomes (1)
Self-reported medication adherence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startNov 2002
- Primary completionJan 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ira B. Wilson, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870792
- Sponsor's protocol ID
- ibwadhrct88$
- Acronym
- MAP
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
PubMed 17577653Vranceanu AM, Safren S, Cowan J, Ring D. The development of the negative pain thoughts questionnaire. Pain Pract. 2008 Sep-Oct;8(5):337-41. doi: 10.1111/j.1533-2500.2008.00213.x. Epub 2008 May 23.
PubMed 18503620
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
- ClinicalTrials.gov ID
- NCT00870792
- Acronym / sponsor ID
- MAP / ibwadhrct88$
- Conditions
- HIV Infection, HIV Infections
- Keywords
- HIV, antiretroviral therapy, medication adherence, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Nov 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 27 Mar 2009 (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.
We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received report | Active comparator | Behavioral: Adherence report |
| Routine care | Placebo comparator | Behavioral: Adherence reportPatients receive usual, routine, care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- on ART
- willing to use MEMS cap
- speaks and reads English
- detectable viral loads
Key exclusion criteria (1 listed)
- uses a pill box
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 |
|---|---|---|
| Adherence reportDuring the intervention phase, the data collected at the study visit were summarized in a 3-page report that was given to the provider before each intervention visit. The report included data on self-reported adherence, MEMS adherence, reminder use, beliefs about ART, reasons for missed doses, alcohol and drug use, and depression. | Behavioural | Received report, Routine care |
Primary outcome
Antiretroviral medication adherence as assessed by electronic pill cap monitoring.
Time frame: 6 months
1 secondary outcome
Self-reported medication adherence
Time frame: 6 months
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 11 Jan 2017.
- Background: PubMed 17577653Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
- Background: PubMed 18503620Vranceanu AM, Safren S, Cowan J, Ring D. The development of the negative pain thoughts questionnaire. Pain Pract. 2008 Sep-Oct;8(5):337-41. doi: 10.1111/j.1533-2500.2008.00213.x. Epub 2008 May 23.
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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.
Ira B. Wilson, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence report in people with HIV Infection and HIV Infections, run by National Institute on Drug Abuse (NIDA) 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 4 inclusion and 1 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 11 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
Antiretroviral medication adherence as assessed by electronic pill cap monitoring. (time frame: 6 months). 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 NCT00870792, which also lists 2 linked publications.
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 11 Jan 2017.