HIV InfectionsPhase 3ECHONCT00675610
Enhancing Communication and HIV Outcomes
A Phase 3 study testing communication training in people with HIV Infections, run by Johns Hopkins University at 3 sites in United States.
Trial summary
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to May 2010
- 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
- Currently providing primary care to at least 10 HIV-infected patients in the clinic
- Physician, Nurse-Practitioner, or Physician-Assistant
- Agree to give written informed consent.
- HIV-infected patient of one of the participating providers
- Has had at least one prior visit with that provider
- Currently taking antiretroviral therapy
Show all 10Show fewer
- Capable of understanding and giving written informed consent
- Age > 20 years old
- English-speaking
- African-American (or people of African descent living in the United States), Hispanic, or non-Hispanic White race/ethnicity
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wayne State University
Detroit, Michigan, 48201
Saint Lukes-Roosevelt
New York, New York, 10023
Oregon Health Science University
Portland, Oregon, 97239
About this study
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression.
Read the detailed description
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. We will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression. The following primary and secondary hypotheses will be addressed.
Primary Hypothesis.
- There will be more and higher quality patient-provider communication about antiretroviral medication adherence in the intervention compared to control arm at both visit 1 (V1) and visit 2 (V2).
Secondary Hypotheses
- Higher quality patient-provider communication in the intervention arm will be associated with
- higher patient ratings of communication (overall, HIV-specific, adherence-specific, and interpersonal style of provider) at V1 and V2;
- increased patient preference for a shared decision-making role at V1 and V2;
- more positive health beliefs at V1 and V2;
- higher patient medication self-efficacy at V1 and V2;
- better adherence to antiretroviral medication (assessed by 3-day recall) at V2; and
- a greater percentage of patients with HIV-1 RNA suppression at V2.
- The intervention will reduce disparities in medication self-efficacy, adherence, and HIV-1 RNA suppression.
- Conditions
- HIV Infections
- Being tested
- communication training
- Keywords
- communication, HIV/AIDS, Treatment Experienced
- Medical subject headings
- HIV Infections, Communication, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication trainingBehavioural
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | providers are not trained and patients are not coached |
| intervention arm | Experimental | providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers Receives: Behavioral: communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-provider communication
Measured: 1 day- 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2010
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 Johns Hopkins UniversityThe 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Mary Catherine Beach, Johns Hopkins University
- Investigators
- Mary Catherine Beach, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675610
- Sponsor's protocol ID
- ECHO-01
- Other IDs
- 290-01-0012
- Acronym
- ECHO
- Status last verified
- Mar 2015
- First submitted
- 7 May 2008
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Communication and HIV Outcomes
- ClinicalTrials.gov ID
- NCT00675610
- Acronym / sponsor ID
- ECHO / ECHO-01
- Conditions
- HIV Infections
- Keywords
- communication, HIV/AIDS, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 May 2008 (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.
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression.
Detailed description
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. We will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression. The following primary and secondary hypotheses will be addressed.
Primary Hypothesis.
- There will be more and higher quality patient-provider communication about antiretroviral medication adherence in the intervention compared to control arm at both visit 1 (V1) and visit 2 (V2).
Secondary Hypotheses
- Higher quality patient-provider communication in the intervention arm will be associated with
- higher patient ratings of communication (overall, HIV-specific, adherence-specific, and interpersonal style of provider) at V1 and V2;
- increased patient preference for a shared decision-making role at V1 and V2;
- more positive health beliefs at V1 and V2;
- higher patient medication self-efficacy at V1 and V2;
- better adherence to antiretroviral medication (assessed by 3-day recall) at V2; and
- a greater percentage of patients with HIV-1 RNA suppression at V2.
- The intervention will reduce disparities in medication self-efficacy, adherence, and HIV-1 RNA suppression.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –providers are not trained and patients are not coached |
| intervention arm | Experimental | Behavioral: communication trainingproviders are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Currently providing primary care to at least 10 HIV-infected patients in the clinic
- Physician, Nurse-Practitioner, or Physician-Assistant
- Agree to give written informed consent.
- HIV-infected patient of one of the participating providers
- Has had at least one prior visit with that provider
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 |
|---|---|---|
| communication trainingproviders are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers | Behavioural | intervention arm |
Primary outcome
patient-provider communication
Time frame: 1 day- 3 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 1 Apr 2015.
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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.
Mary Catherine Beach, MD, MPH principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing communication training in people with HIV Infections, run by Johns Hopkins University at 3 sites 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 10 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
patient-provider communication (time frame: 1 day- 3 months). 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 1 Apr 2015.