HIVARCHNCT02610517
ARCH Research Protocol for Provider Alcohol Pharmacotherapy Training and Assessment
A study testing Provider Training and Patient Intervention in people with HIV and Alcoholism, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Alcoholism
- What is being tested?
- Provider Training and Patient Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2013to Feb 2016
- 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
- At least 18 years or older
- Receiving HIV care at The UAB 1917 Clinic
- Hazardous drinkers as defined by an at-risk alcohol use score on the alcohol related, self-report data collected through the CNICS PRO.
- English speaking
- Willing to participate and provide informed consent
Who cannot join
- Pregnant or nursing women will be referred to social work for more intensive intervention per standard of care.
- Cognitive impairment such as they cannot provide informed consent
- Non-English speaker
- A visibly intoxicated person will be deferred for consent by the research assistant but will remain eligible for the study
- Patients who previously declined to participate in the project
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2050
University of Washington
Seattle, Washington, 98195
About this study
Official title: Integration of Evidence-based Alcohol Interventions Into HIV Care (ARCH-IRA) (Phases 1- Provider Training and 2- Patient Intervention)
Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting.
Read the detailed description
This study is divided into 2 phases: provider training (Phase 1) and patient level intervention (Phase 2). Phase 1, provider training, is managed through an administrative grant at Johns Hopkins. Providers will be notified of the research project locally but all training and assessments will be through Johns Hopkins.
Phase 1:
Training providers to offer alcohol pharmacotherapy (APT) to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population. However, it is unknown how Infectious Disease providers will feel about treating alcohol use disorders within HIV clinics. Further it is uncertain the specific provider and clinic barriers to implementing this type of program in a primary care setting. A web-based alcohol pharmacotherapy provider training will be provided across the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. At the two intervention sites (University of Alabama at Birmingham and the University of Washington), providers will receive an on-site training in addition to the web-based training on alcohol pharmacotherapy administered at all 8 sites.
The following are the specific aims of this project:
Aim 1: To evaluate provider attitudes before and after alcohol pharmacotherapy training.
Aim 2: To determine barriers and facilitators to alcohol treatment implementation in HIV specialty clinics.
Phase 2:
Determine the effectiveness of computer-delivered brief interventions (CBI) for reducing hazardous drinking in the HIV clinical care setting at two intervention clinics: University of Alabama at Birmingham (UAB) and the University of Washington (UW). The combination of CBI plus alcohol pharmacotherapy (APT) provider training (Phase 1) will be piloted in two clinics in the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. Across all 8 CNICS sites, all patients will be screened for hazardous or binge drinking using the AUDIT (Alcohol Use Disorders Identification Test) and MINI (Mini-International Neuropsychiatric Interview) instruments. At UAB and UW, patients who screen eligible (self-report of hazardous or binge drinking using the AUDIT and MINI instruments) will be approached for participation. The data collected through this protocol will be used to compare Standard of Care as noted in Aim 2 below. Standard of Care at UAB includes potential referral to an in-house substance abuse program or an outside agency, both of which are based on the provider's discretion. Providers have the option of offering alcohol pharmacotherapy but this has not been used to date routinely.
Specific aims of this proposal are:
Aim 1: Develop a tailored CBI intervention that addresses alcohol risks specific to HIV-infected patients.
Aim 2: Compare the effectiveness of CBI + APT versus standard care for reducing alcohol use among hazardous drinking HIV infected individuals.
Aim 3: Determine patient-level predictors of CBI and APT engagement and effectiveness.
Aim 4: Determine the facilitators and barriers to successful integration and implementation of these interventions into HIV clinical settings.
- Conditions
- HIV, Alcoholism
- Being tested
- Provider Training, Patient Intervention
- Keywords
- Hazardous alcohol use, Computer based intervention (CBI), Pharmacotherapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider TrainingBehavioural
All providers will receive an online survey about alcohol pharmacotherapy, and an on-site training on alcohol pharmacotherapy will be offered at UAB and UW. The training will cover the most commonly prescribed alcohol pharmacotherapy. Some medications (ex: Zofran) have been used clinically for alcohol pharmacotherapy but have not yet received FDA approval for this indication. Research has shown these medications are beneficial as alcohol pharmacotherapy and are more frequently used by doctors due to the more favorable side effects. Providers in this study will use their clinical judgment in prescribing alcohol medications per their normal standard of care and using any new information gained from the alcohol pharmacotherapy training.
Patient InterventionBehavioural
Eligible participants will be screened using the Audit and Mini instruments that are routinely asked during regular clinic visits. Once a participant consents, they will be shown 2 computerized brief interventions (CBIs) - one after enrollment (visit 1) and one 3-6 months after enrollment (visit 2). Participants will interact with the touch-screen computer via Peedy the Parrot, a three dimensional animated character. The intervention emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. At the end of both visits, patients will complete a patient satisfaction survey with questions related to ease of use of CBI and satisfaction with program content. Providers will have the opportunity to prescribe pharmacotherapy at visit 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| Provider Training | Other | Training providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population. Receives: Behavioral: Provider Training |
| Patient Intervention | Other | Determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting at two intervention clinics: University of Alabama at Birmingham (UAB) and the University of Washington (UW). Receives: Behavioral: Patient Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks per week
The Alcohol Use Disorders Identification Test (AUDIT) instrument will be used to assess drinks per week. This is a self-reported instrument.
Measured: up to 1 year after enrollment
Binge drinking episodes
The Mini-International Neuropsychiatric Interview (MINI) instrument will be used to assess binge drinking episodes. This is a self-reported instrument.
Measured: up to 1 year after enrollment
Secondary outcomes (5)
Number of participants that initiate/request alcohol pharmacotherapy
Prescription of alcohol pharmacotherapy - number of participants obtaining a prescription at enrollment and/or after visit 2.
Measured: at enrollment and after visit 2 (3 - 6 months after enrollment)
Number of participants that complete a CNICS Patient Reported Outcome (PRO)
The CNICS PRO is a patient self-reported questionnaire that is asked every 3 - 6 months during a regular clinic visit. The instruments that are used include:
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST); Adult AIDS Clinical Trials Group (AACTG) Adherence; HIV Risk Behaviors; Quality of Life (EuroQOL); Patient Health Questionnaire for Depression and Anxiety (PHQ-9 - Depression; PHQ-5 - Anxiety); Tobacco; Physical Activity
Measured: every 3 - 6 months after enrollment and at 12 months after enrollment
Number of participants that initiate antiretroviral therapy (ART)
New prescription of ART if they previously were not on therapy
Measured: every 3 - 6 months after enrollment and at 12 months after enrollment
Mean number of participants that adhere to HIV clinic visits
Medical records data will be used to record the data
Measured: for 1 year after enrollment
Number of subjects with HIV-RNA level (viral loads) < 20 copies/ml
Virological suppression to < 20 copies/ml
Measured: 1 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJun 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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 Alabama at BirminghamThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Johns Hopkins University
- Responsible party
- Principal investigator, Michael Saag, MD, University of Alabama at Birmingham
- Investigators
- Michael S Saag, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610517
- Sponsor's protocol ID
- F121009007
- Acronym
- ARCH
- Status last verified
- May 2024
- First submitted
- 29 Aug 2015
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Evidence-based Alcohol Interventions Into HIV Care (ARCH-IRA) (Phases 1- Provider Training and 2- Patient Intervention)
- ClinicalTrials.gov ID
- NCT02610517
- Acronym / sponsor ID
- ARCH / F121009007
- Conditions
- HIV, Alcoholism
- Keywords
- Hazardous alcohol use, Computer based intervention (CBI), Pharmacotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Washington, Johns Hopkins University
- Study start
- Jun 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Nov 2015 (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.
Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting.
Detailed description
This study is divided into 2 phases: provider training (Phase 1) and patient level intervention (Phase 2). Phase 1, provider training, is managed through an administrative grant at Johns Hopkins. Providers will be notified of the research project locally but all training and assessments will be through Johns Hopkins.
Phase 1:
Training providers to offer alcohol pharmacotherapy (APT) to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population. However, it is unknown how Infectious Disease providers will feel about treating alcohol use disorders within HIV clinics. Further it is uncertain the specific provider and clinic barriers to implementing this type of program in a primary care setting. A web-based alcohol pharmacotherapy provider training will be provided across the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. At the two intervention sites (University of Alabama at Birmingham and the University of Washington), providers will receive an on-site training in addition to the web-based training on alcohol pharmacotherapy administered at all 8 sites.
The following are the specific aims of this project:
Aim 1: To evaluate provider attitudes before and after alcohol pharmacotherapy training.
Aim 2: To determine barriers and facilitators to alcohol treatment implementation in HIV specialty clinics.
Phase 2:
Determine the effectiveness of computer-delivered brief interventions (CBI) for reducing hazardous drinking in the HIV clinical care setting at two intervention clinics: University of Alabama at Birmingham (UAB) and the University of Washington (UW). The combination of CBI plus alcohol pharmacotherapy (APT) provider training (Phase 1) will be piloted in two clinics in the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. Across all 8 CNICS sites, all patients will be screened for hazardous or binge drinking using the AUDIT (Alcohol Use Disorders Identification Test) and MINI (Mini-International Neuropsychiatric Interview) instruments. At UAB and UW, patients who screen eligible (self-report of hazardous or binge drinking using the AUDIT and MINI instruments) will be approached for participation. The data collected through this protocol will be used to compare Standard of Care as noted in Aim 2 below. Standard of Care at UAB includes potential referral to an in-house substance abuse program or an outside agency, both of which are based on the provider's discretion. Providers have the option of offering alcohol pharmacotherapy but this has not been used to date routinely.
Specific aims of this proposal are:
Aim 1: Develop a tailored CBI intervention that addresses alcohol risks specific to HIV-infected patients.
Aim 2: Compare the effectiveness of CBI + APT versus standard care for reducing alcohol use among hazardous drinking HIV infected individuals.
Aim 3: Determine patient-level predictors of CBI and APT engagement and effectiveness.
Aim 4: Determine the facilitators and barriers to successful integration and implementation of these interventions into HIV clinical settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Training | Other | Behavioral: Provider TrainingTraining providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population. |
| Patient Intervention | Other | Behavioral: Patient InterventionDetermine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting at two intervention clinics: University of Alabama at Birmingham (UAB) and the University of Washington (UW). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years or older
- Receiving HIV care at The UAB 1917 Clinic
- Hazardous drinkers as defined by an at-risk alcohol use score on the alcohol related, self-report data collected through the CNICS PRO.
- English speaking
- Willing to participate and provide informed consent
Key exclusion criteria (5 listed)
- Pregnant or nursing women will be referred to social work for more intensive intervention per standard of care.
- Cognitive impairment such as they cannot provide informed consent
- Non-English speaker
- A visibly intoxicated person will be deferred for consent by the research assistant but will remain eligible for the study
- Patients who previously declined to participate in the project
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 |
|---|---|---|
| Provider TrainingAll providers will receive an online survey about alcohol pharmacotherapy, and an on-site training on alcohol pharmacotherapy will be offered at UAB and UW. The training will cover the most commonly prescribed alcohol pharmacotherapy. Some medications (ex: Zofran) have been used clinically for alcohol pharmacotherapy but have not yet received FDA approval for this indication. Research has shown these medications are beneficial as alcohol pharmacotherapy and are more frequently used by doctors due to the more favorable side effects. Providers in this study will use their clinical judgment in prescribing alcohol medications per their normal standard of care and using any new information gained from the alcohol pharmacotherapy training. | Behavioural | Provider Training |
| Patient InterventionEligible participants will be screened using the Audit and Mini instruments that are routinely asked during regular clinic visits. Once a participant consents, they will be shown 2 computerized brief interventions (CBIs) - one after enrollment (visit 1) and one 3-6 months after enrollment (visit 2). Participants will interact with the touch-screen computer via Peedy the Parrot, a three dimensional animated character. The intervention emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. At the end of both visits, patients will complete a patient satisfaction survey with questions related to ease of use of CBI and satisfaction with program content. Providers will have the opportunity to prescribe pharmacotherapy at visit 1 and 2. | Behavioural | Patient Intervention |
Primary outcome
Drinks per week
Time frame: up to 1 year after enrollment
The Alcohol Use Disorders Identification Test (AUDIT) instrument will be used to assess drinks per week. This is a self-reported instrument.
Binge drinking episodes
Time frame: up to 1 year after enrollment
The Mini-International Neuropsychiatric Interview (MINI) instrument will be used to assess binge drinking episodes. This is a self-reported instrument.
5 secondary outcomes
Number of participants that initiate/request alcohol pharmacotherapy
Time frame: at enrollment and after visit 2 (3 - 6 months after enrollment)
Number of participants that complete a CNICS Patient Reported Outcome (PRO)
Time frame: every 3 - 6 months after enrollment and at 12 months after enrollment
Number of participants that initiate antiretroviral therapy (ART)
Time frame: every 3 - 6 months after enrollment and at 12 months after enrollment
Mean number of participants that adhere to HIV clinic visits
Time frame: for 1 year after enrollment
Number of subjects with HIV-RNA level (viral loads) < 20 copies/ml
Time frame: 1 year post enrollment
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 3 Jun 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.
Michael S Saag, MD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Training and Patient Intervention in people with HIV and Alcoholism, run by University of Alabama at Birmingham 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 5 inclusion and 5 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 3 Jun 2024. 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.
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?
Drinks per week (time frame: up to 1 year after enrollment). The study lists 2 primary outcomes in all. 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 3 Jun 2024.