HIVABCSinHIVNCT03902431
Translating the ABCS Into HIV Care
A study testing ABCS training in people with HIV and Cardiovascular Risk Factor, run by University of Rochester at 1 site in United States.
Trial summary
The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- HIV, Cardiovascular Risk Factor
- What is being tested?
- ABCS training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,277 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 31 May 2024
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sites:
- Serve a cohort of at least 100 HIV patients
- Have an Electronic Health Record (EHR)
- Agree to collaborate on implementing feasible adaptations of intervention strategies
- Patients:
- Patient of the site with a diagnosis of HIV
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- Age 40-79 years
- ≥5% risk for CVD as calculated using the ASCVD Risk Estimator Plus
- Willing to participate
- No plans to leave the site in the next 12 months
- Proficient in either English or Spanish
- Own a cell phone with texting capabilities
- Clinicians:
- Physicians, Physicians Assistants, or Nurse Practitioners who provide direct HIV care to patients
- Work at a participating site
- Willing to implement the project's intervention strategies
Who cannot join
- Patients:
- Currently participating in another CVD trial
- Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA)
- Have had a CVD procedure such as installation of a stent or angioplasty
- Have peripheral vascular disease, intermittent claudication or peripheral arterial disease
- Are pregnant
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- Lacks capacity to consent
- Clinicians:
- Planning to leave the site within the next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation Research: Translating the ABCS Into HIV Care
The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing CVD morbidity and mortality among PLH.
Read the detailed description
Our project has two major aims:
Aim 1: To assess the impact of the implementation of an evidence-based, multilevel strategy to reduce cardiovascular vascular disease (CVD) among PLH.
Aim 2: To assess the process of implementation of these strategies using RE-AIM QuEST. Using both quantitative and qualitative methods, we evaluate the process of implementation by assessing Reach, [Effectiveness addressed in Aim 1], Adoption, Implementation and Maintenance whilst integrating Qualitative Evaluation for Systematic Translation.
- Conditions
- HIV, Cardiovascular Risk Factor
- Being tested
- ABCS training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCS trainingBehavioural
Clinicians and patients will be given information regarding the ABCS (Aspirin, Blood Pressure control,Cholesterol control, and Smoking Cessation) and for reducing CVD risk among HIV patients.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | CVD risk prior to the patient and clinician training |
| Training | Experimental | CVD risk after the patient and clinician training Receives: Behavioral: ABCS training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-year CVD risk reduction
This will be based on the ACVSD risk calculator
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start26 Sep 2019
- Primary completion31 Aug 2022
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A stratified clustered randomized stepped wedge design.
- Masking
- None (open label)
- Enrolment
- 4,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Directors Network, University of Texas, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kevin Fiscella, University of Rochester
- Investigators
- Kevin Fiscella, MD, MPH, Principal investigator, University of RochesterJonathan Tobin, PhD, Principal investigator, Clinical Directors Network, Inc; Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902431
- Sponsor's protocol ID
- U01HL142107
- Other IDs
- U01HL142107
- Acronym
- ABCSinHIV
- Status last verified
- Sep 2024
- First submitted
- 1 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Research: Translating the ABCS Into HIV Care
- ClinicalTrials.gov ID
- NCT03902431
- Acronym / sponsor ID
- ABCSinHIV / U01HL142107
- Conditions
- HIV, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,277 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Clinical Directors Network, University of Texas, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 4 Apr 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.
The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing CVD morbidity and mortality among PLH.
Detailed description
Our project has two major aims:
Aim 1: To assess the impact of the implementation of an evidence-based, multilevel strategy to reduce cardiovascular vascular disease (CVD) among PLH.
Aim 2: To assess the process of implementation of these strategies using RE-AIM QuEST. Using both quantitative and qualitative methods, we evaluate the process of implementation by assessing Reach, [Effectiveness addressed in Aim 1], Adoption, Implementation and Maintenance whilst integrating Qualitative Evaluation for Systematic Translation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stratified clustered randomized stepped wedge design.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –CVD risk prior to the patient and clinician training |
| Training | Experimental | Behavioral: ABCS trainingCVD risk after the patient and clinician training |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Serve a cohort of at least 100 HIV patients
- Have an Electronic Health Record (EHR)
- Agree to collaborate on implementing feasible adaptations of intervention strategies
- Patient of the site with a diagnosis of HIV
- Age 40-79 years
Key exclusion criteria (9 listed)
- Currently participating in another CVD trial
- Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA)
- Have had a CVD procedure such as installation of a stent or angioplasty
- Have peripheral vascular disease, intermittent claudication or peripheral arterial disease
- Are pregnant
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 |
|---|---|---|
| ABCS trainingClinicians and patients will be given information regarding the ABCS (Aspirin, Blood Pressure control,Cholesterol control, and Smoking Cessation) and for reducing CVD risk among HIV patients. | Behavioural | Training |
Primary outcome
10-year CVD risk reduction
Time frame: 12 months
This will be based on the ACVSD risk calculator
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 19 Sep 2024.
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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.
Kevin Fiscella, MD, MPH principal investigator
University of Rochester
Jonathan Tobin, PhD principal investigator
Clinical Directors Network, Inc; Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABCS training in people with HIV and Cardiovascular Risk Factor, run by University of Rochester 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 16 inclusion and 9 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 19 Sep 2024. 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.
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?
10-year CVD risk reduction (time frame: 12 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 19 Sep 2024.