Clinical trial NCT02938377
Conditions: HIV Positive Alcohol Use
Sponsor: University of Alabama at Birmingham
Start date: 2017-11-06; Completion date: 2023-11-01
Enrollment: 4985 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms.

Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes.

Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions

Detailed description:
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease drinking quantity and or frequency compared to pre-algorithm levels. Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD symptoms compared to pre-algorithm symptoms levels.

Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits and HIV medications compared to pre-algorithm levels. Hypothesis 2B. Patients who receive algorithm-guided treatment will have improved HIV biomarkers (e.g., CD4 and VL). Hypothesis 3B. There will be a positive relationship between VL and alcohol consumption measured by self-report and PEth level.

Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, HCV, other drug use disorders). Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving algorithm-guided treatment will have better alcohol, mental health and HIV treatment outcomes compared to similar individuals in SC. Hypothesis 3B: PLWH with comorbid HCV receiving algorithm-guided treatment will have improved FIB4 results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug use will decrease among those receiving algorithm-guided treatment vs SC.

Arms: arm 1: Computerized Brief Intervention (CBI)- a video about alcohol abuse arm 2: Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy arm 3: Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol.
Interventions: intervention 1: Computerized Brief Intervention (CBI) intervention 2: CBT4CBT intervention 3: Recommendation and Counseling for Alcohol Pharmacotherapy
Intervention descriptions: intervention 1: A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. intervention 2: 9 computerized modules delivered at the participant's pace intervention 3: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.

Protocol documents:
ICF_002.pdf: 
Page 1 of 9
Version Date:  6/26/2019
TITLE OF RESEARCH:
Alcohol Research Consortium in HIV-
Intervention Research Arm (ARCH-IRA)
IRB PROTOCOL:
IRB-160706007
PRINCIPAL INVESTIGATOR:
Karen L. Cropsey, Psy.D.
SPONSOR:
National Institute on Alcohol Abuse and Alcoholism 
(NIAAA)
Purpose of the Research
You are being asked to participate in a research study to test a method that was 
designed to reduce risky drinking. We hope to learn if this method helps to reduce 
drinking. 
 
Research studies include only people who choose to take part.  Please read this 
consent form carefully and take your time making your decision. As a study staff 
member discusses this consent form with you, please ask him/her to explain any 
information that you do not clearly understand.  We expect that a total of 606 
participants will be enrolled at UAB, the University of California at San Diego, and the 
University of Washington.  Approximately 259 of these participants will be enrolled at 
UAB.
Explanation of Procedures
As part of your routine assessment on the computer for the CNICS study, you are asked 
questions about alcohol use. Based on your responses to these questions, we are 
asking you to also participate in a study designed to reduce risky alcohol use. You will 
watch a brief video about alcohol use and participate in online counseling, if 
recommended by an algorithm (a set of guidelines or rules for making decisions).  This 
information, along with guidelines about treatment options for hazardous alcohol use, 
will be given to your HIV doctor. Your doctor may offer you medicine to help with your 
alcohol use.
The interventions we use in this study will depend on the severity of your alcohol use.  
After your initial visit, when you return for your next two follow-up clinic visits at about 
four to six and at about 12 months following your first visit, we will approach you again. 
At these visits we will ask you to complete a few questionnaires that you usually do at 
the clinic visit. 
Interventions
Group 1: Those with risky drinking who do not meet the diagnosis of alcohol use 
disorder or have an alcohol disorder classified as mild and do not have depression, or 
panic disorder
Visit 1: You will see a brief computer-delivered video regarding alcohol use and 
asked to complete a patient satisfaction survey about how you liked the videos 
Informed Consent 
UAB IRB
Approved
02-Jul-2019
until
18-Jun-2020


Page 2 of 9
Version Date:  6/26/2019
and using the computer system. The surveys will be used to develop future 
computer-based interventions. 
Visit 2 (at about 4-6 months later; could be earlier or later): If drinking has been 
reduced, you will watch a video congratulating you on reducing or stopping your 
drinking. If drinking is still risky, you will watch another video regarding alcohol 
use and asked to complete a patient satisfaction survey about how you liked the 
videos and using the computer system. The surveys will be used to develop 
future computer-based interventions.  You will be encouraged to go online and 
complete the 6 modules of Computer Based Training for Cognitive Behavioral 
Therapy (CBT4CBT) designed to address risky drinking behavior and a 7th 
module addressing risky HIV behavior. These modules can be done at your own 
pace in your home. If study staff cannot meet to follow up on CBT4CBT during 
Visit 2, we will call you in about a week’s time from Visit 2 to follow up on the 
progress of the CBT4CBT component. Study staff may make up to 6 attempts in 
about a month’s time to reach you.
Group 2: Those with risky drinking who do not meet the diagnosis of alcohol use 
disorder or meet alcohol use disorder classified as mild, but do have depression, or 
panic disorder
Visit 1: You will see a brief computer-delivered video regarding alcohol use and 
asked to complete a patient satisfaction about how you liked the videos and 
using the computer system.  You will be encouraged to go online and complete 
the 6 modules of Computer Based Training for Cognitive Behavioral Therapy 
(CBT4CBT) designed to address risky drinking behavior and a 7th module 
addressing risky HIV behavior. These modules can be done at your own pace in 
your home. Around a week from enrollment, we will call you to follow-up on the 
progress of the Computer Based Training for Cognitive Behavioral Therapy 
(CBT4CBT) computer study component. Study staff may make up to 6 attempts 
in about a month’s time to reach you.
Visit 2 (at about 4-6 months later; could be earlier or later): If drinking has been 
reduced, you will watch a video congratulating you on reducing or stopping your 
drinking. If study staff cannot meet to follow up on CBT4CBT during Visit 2, we 
will call you in about a week’s time from Visit 2 to follow up on the progress of the 
CBT4CBT component.  Study staff may make up to 6 attempts in about a 
month’s time to reach you.
 
If your drinking is still risky, you will watch another video regarding alcohol use, 
complete another patient satisfaction questionnaire, and an algorithm will be 
used to determine the best medication to help with your alcohol use. In addition, 
an addiction-trained physician may make a recommendation to your doctor for 
medication to help reduce your drinking. The medications recommended in this 


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study are naltrexone, acamprosate, or disufiram, which are all FDA-approved to 
treat alcohol disorders. 
Group 3: Those with risky drinking who meet the diagnosis of alcohol use 
disorder classified as moderate or severe with or without depression, or panic 
disorder
Visit 1: You will see a brief computer-delivered video regarding alcohol use, 
complete another patient satisfaction questionnaire, you will be encouraged to go 
online and complete the 6 modules of Computer Based Training for Cognitive 
Behavioral Therapy (CBT4CBT) designed to address risky drinking behavior and 
a 7th module addressing risky HIV behavior. These modules can be done at your 
own pace in your home. Around a week from enrollment, we will call you to 
follow-up on the progress of the CBT4CBT computer study component. Study 
staff may make up to 6 attempts in about a month’s time to reach you.
A recommendation will be made to your doctor for medication to help reduce 
your alcohol consumption. The medications recommended in this study are 
naltrexone, acamprosate, or disufiram, which are all FDA-approved medications 
to treat alcohol disorders. 
Visit 2 (at about 4-6 months later; could be earlier or later): If drinking has been 
reduced, you will watch a video congratulating you on reducing or stopping your 
drinking and will continue the medication prescribed by your doctor.
If your drinking is still risky, you will watch another video regarding alcohol use, 
complete another patient satisfaction questionnaire, and will continue the 
medication prescribed by your doctor.
If study staff cannot meet to follow up on CBT4CBT during Visit 2, we will call you 
in about a week’s time from Visit 2 to follow up on the progress of the CBT4CBT 
component. Study staff may make up to 6 attempts in about a month’s time to 
reach you.
All groups have the option of scheduling another visit to view the video and do the 
surveys. If you wish, the study staff can call you to remind you about your scheduled 
visit. 
If you choose to give us your cell phone number, all groups will receive approximately 
three texts per week with inspirational/educational messages regarding how to handle 
risky drinking behaviors for 4 weeks. You will be asked if you wish to receive 2, 3, or 4 
texts per week and you may opt out of texts if you wish by responding with STOP to any 
text message you receive. These texts be generated by the “PEEDY” software program 
and will be one-way, meaning that you will receive them but will not be able to reply. 
Any medications to treat alcohol dependence that may be prescribed or other medical 
services that may be provided as part of a treatment plan for your alcohol use will be 
part of your usual clinical care.  Your clinical information regarding any alcohol 


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pharmacotherapy your provider prescribes will be gathered during the time of the study, 
coded, and included in the database.   You will be asked to allow study staff to look at 
your medical records.  These records will be reviewed for information related to your 
health care visits such as treatment history and laboratory tests.  We will also review 
your records to obtain contact information, in case the study staff needs to contact you 
for any reason. If you receive alcohol pharmacotherapy (treatment with medication) and 
request your medications be mailed to you, study staff will verify your address per 
standard clinic protocols. Study staff or your patient care coordinator will call you 
periodically to ask you about side effects of your medication and about your progress on 
the CBT4CBT modules. We are also requesting your permission to use your data from 
your electronic medical record and the CNICS study, including the questions you 
answer via touch screen computer at the start of your visit. The study will use the 
information captured in the CNICS questionnaires during the timeframe of 9-18 months 
from enrollment as well. 
Risks and Discomforts
It is possible that over the course of watching the brief computer intervention and 
answering questions in the video, some questions or topics might cause you distress. 
Although we believe this unlikely to occur, study staff will escort you to the Psychiatry 
Clinic or Emergency Room for evaluation if needed. You can ask that the video be 
stopped at any time. 
You should know that text messages, including ones from our study, are not 100% 
secure and may be accessed by someone outside the research project during 
transmission. While this is unlikely, it is still a risk.
If you stop using alcohol suddenly, you may experience alcohol withdrawal symptoms 
which include sweating or increased heart rate (over 100 beats per minute), increased 
hand tremor, insomnia, nausea or vomiting, transient visual, auditory or tactile 
hallucinations, psychomotor agitation, anxiety, and generalized tonic-clonic seizures. 
Participants who have been drinking heavily for an extended period of time will be 
evaluated for the need of medical detoxification and will be referred to inpatient 
services. Any participants who need alcohol treatment beyond the scope of this project 
will be referred for appropriate outside treatment.
Should your doctor choose to provide you medication to treat alcohol dependence, you 
should discuss the risks and benefits of your alcohol treatment plan with your doctor.  
As medications to treat alcohol dependence may have side effects or interact with other 
drugs you are taking, make sure you tell your doctor about all the prescription drugs, 
herbal products, over-the-counter (OTC) drugs, vitamins and natural remedies that you 
are taking.  These risks and benefits are not specific to this research study but may 
be part of the treatment that you and your doctor will decide on for your alcohol use.  


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Although this study is not about the efficacy or safety of the following FDA approved 
medications recommended in this study, the following is a list of the possible side 
effects of the medications:
The most common side effects associated with the use of naltrexone include nausea or 
vomiting, diarrhea, constipation, stomach pain or cramping, loss of appetite, dizziness, 
anxiety, insomnia, drowsiness, headache, mild discomfort at the injection site (injectable 
form), rash, tearfulness, change in energy, or muscle/joint pain. Less common and more 
serious side effects naltrexone include signs of an allergic reaction (rash, hives, itching, 
breathing difficulties, chest tightness, swelling of the mouth, face, lips, or tongue), 
hallucinations, confusion, blurred vision or eye problems, cough, wheezing, or breathing 
troubles, severe vomiting or diarrhea. Naltrexone can cause liver damage which would 
manifest in the following symptoms: pain in the upper right part of the stomach that last 
more than a few days, yellowing of the skin or eyes, excessive fatigue, unusual bleeding 
or bruising, loss of appetite, dark urine, and light colored bowel movements. If you are 
using opioids (e.g., prescription pain medications or heroin) you should tell your doctor 
as naltrexone will cause immediate withdrawal symptoms from opioids.
The most common side effects associated with acamprosate include nausea, vomiting, 
stomach pain, loss of appetite; constipation, diarrhea; headache, dizziness, drowsiness; 
vision problems; problems with memory or thinking; weakness, cold or flu-like 
symptoms; back pain, joint or muscle pain; dry mouth, decreased or distorted sense of 
taste; sleep problems (insomnia); impotence, loss of interest in sex; sweating, mild skin 
rash; or numbness or tingly feeling. Less common but more serious side effects include 
mood or behavior changes; suicidal thoughts; severe anxiety or depression; feeling like 
you might pass out; fast or pounding heartbeats; swelling, weight gain, feeling short of 
breath; confusion, increased thirst; or urinating less than usual or not at all; or signs of 
an allergic reaction (rash, hives, itching, breathing difficulties, chest tightness, swelling 
of the mouth, face, lips, or tongue). 
The most common side effect associated with disulfiram include skin rash or acne; mild 
headaches; mild drowsiness or tiredness; impotence; metallic taste in the mouth; or 
swollen or sore tongue. Less common but more severe side effects include an allergic 
reaction (swelling of your lips, tongue, or face; shortness of breath; closing of your 
throat; or hives); seizures; extreme tiredness; dark urine; yellowing of the skin or eyes 
(jaundice); large appetite changes; weakness, dizziness or loss of coordination; or 
severe diarrhea or vomiting. 
There is the risk of loss of confidentiality, but we will take every precaution to protect 
your confidentiality. 
Information for Women of Childbearing Potential or 
Men Capable of Fathering a Child
Some alcohol medications may have additional risks when taken during pregnancy or 
breastfeeding, and may also influence sperm production.  These risks are not specific to 
this research study but may be part of the treatment that you and your doctor will decide 
on for your alcohol use. Women who desire to become pregnant or men who may father 


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a child should discuss with their doctor the risks of any medicines before starting the 
medicine.  If you become pregnant, Dr. Cropsey, one of her colleagues on the study or 
your clinic doctor may decide it is in your best interest to take you out of the study. This 
will not affect your routine clinic visits. 
Benefits
You may or may not benefit by being in the study; however, the results of this study may 
help us to learn how to improve patient services at this clinic.
Alternatives
One alternative is always possible:  you can choose not to participate in the study and, 
instead, receive routine treatment.  Participating or not participating in the study will not 
prevent your treatment here or at any other agency where you seek treatment.
Confidentiality
Information obtained about you for this study will be kept confidential to the extent 
allowed by law.  However, research information that identifies you may be shared with 
the UAB Institutional Review Board (IRB) and others who are responsible for ensuring 
compliance with laws and regulations related to research, including people on behalf of 
the National Institutes on Alcohol Abuse and Alcoholism (NIAAA), our collaborators at 
the University of Washington and Johns Hopkins; and the Office for Human Research 
Protections (OHRP). The information from the research may be published for scientific 
purposes; however, your identity will not be given out.  
Information obtained during the course of the study which, in the opinion of the 
investigator(s), suggests that you may be at significant risk of harm to yourself or others 
will be reportable to a third party in the interest of protecting the rights and welfare of 
those at potential risk.
Only a code number, not your name, will be used to identify your information on study 
materials, including lab specimens. This will be maintained in a password-protected 
computer database on a secure server within the UAB 1917 Clinic, the Bevill Biomedical 
Research Building (BBRB), and study staff offices. Any paper materials linking your 
name and code number will be kept in locked filing cabinets in locked offices of study 
personnel on a need-to-have basis.  Your study materials will be maintained for a period 
of three years after the conclusion of the study.  At that time the research information 
not already in your medical record will be destroyed. Your lab samples will be sent to a 
lab outside of UAB (USDTL Lab) and results will be received using a web portal. 
Information from this study may be given to the treating physicians and other medical 
staff at UAB.  In turn, the treating physicians and other medical staff at UAB may 
provide information about your treatment and care to the study staff. Information relating 
to this study, including your name, medical record number, date of birth and social 
security number, may be shared with the billing offices of UAB and UAB Health System 
affiliated entities so that claims may be appropriately submitted to the study sponsor or 


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to your insurance company for clinical services and procedures provided to you during 
the course of the study.
A description of this clinical trial is available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, 
the Web site will include a summary of the results. You can search this Web site at any 
time.
Voluntary Participation and Withdrawal
Taking part in this study is your choice. There will be no penalty if you decide not to be 
in the study and you will not lose any benefits you are otherwise owed. You are free to 
withdraw from this research study at any time. Your choice to leave the study will not 
affect your relationship with this institution. 
You may be removed from the study without your consent if the sponsor ends the study, 
if the study doctor decides it is not in the best interest of your health, or if you are not 
following the study rules.
If you are a UAB student or employee, taking part in this research is not a part of your 
UAB class work or duties.  You can refuse to enroll, or withdraw after enrolling at any 
time before the study is over, with no effect on your class standing, grades, or job at 
UAB. You will not be offered or receive any special consideration if you take part in this 
research. 
Cost of Participation
There will be no cost to you for taking part in this study.  The costs of your standard 
medical care will be billed to you and/or your insurance company in the usual manner.
Payment for Participation in Research
You will not be compensated for this study.
Payment for Research-Related Injuries
UAB and NIH have not provided for any payment if you are harmed as a result of taking 
part in this study. If such harm occurs, treatment will be provided. However, this 
treatment will not be provided free of charge. The cost for that medical care will be billed 
to you or your insurance company, just as for other medical care.
Significant New Findings
You will be told by your doctor or the study staff if new information becomes available 
and might affect your choice to stay in the study.


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Optional Research
Participants may have two blood samples taken (from which blood spots will be 
created), one at baseline, and one at Visit 2 (approximately the 6 month visit), to 
measure blood levels which indicate chronic alcohol use and consumption. We will take 
an extra 2 mL of blood (about 1/2 teaspoon) and this extra blood will only occur when 
you are already having blood drawn as part of another study in which you are 
participating.
Taking blood can cause pain, bleeding, bruising, or swelling and rarely infection at the 
site of the needle sticks. Headaches and lightheadedness may be associated with 
excessive blood collection. Only experienced doctors and clinical staff will perform the 
procedure using standard sterile techniques. 
Please initial one of the following options:
_____Participant agreed for blood spot
_____Participant DID NOT agree for blood spot
Questions
If you have any questions, concerns, or complaints about the research or a research- 
related injury including available treatments, please contact Drs. Karen Cropsey or 
Mugavero. They will be glad to answer any of your questions. Dr. Cropsey’s number is 
205-975-4204. Dr. Mugavero’s number is 205-934-1917. He  may also be reached after 
hours by paging  him at 205-934-3411. 
If you have questions about your rights as a research participant, or concerns or 
complaints about the research, you may contact the Office of the IRB (OIRB) at (205) 
934-3789 or toll free 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 
p.m. CT, Monday through Friday. You may also call this number in the event the 
research staff cannot be reached or you wish to talk to someone else. 
Legal Rights
You are not waiving any of your legal rights by signing this informed consent document.
Signatures
Your signature below indicates that you agree to participate in this study. You will be 
offered a signed or unsigned copy of this document.
___________________________          ____________________
     _____________           
Printed name of Participant                    Signature of Participant                 Date
___________________________          ____________________         _____________
Printed name of Person Obtaining         Signature of Person Obtaining 
Date
Informed Consent
                    Informed Consent


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Version Date:  6/26/2019
University of Alabama at Birmingham
AUTHORIZATION FOR USE/DISCLOSURE OF 
PROTECTED HEALTH INFORMATION (PHI) FOR RESEARCH
Participant Name:  
UAB IRB Protocol Number:  IRB-160706007
Principal Investigator:  Karen L. Cropsey, PsyD
Research Protocol: Alcohol Research 
Consortium in HIV- Intervention Research Arm 
(ARCH-IRA)
Sponsor:  National Institute on Alcohol Abuse and 
Alcoholism
What is the purpose of this form?  You are being asked to sign this form so that UAB may use and release your 
protected health information for research.  Participation in research is voluntary.  If you choose to participate in the 
research, you must sign this form so that your protected health information may be used for the research.
Why do the researchers want my protected health information?  The researchers want to use your protected 
health information as part of the research protocol listed above and as described to you in the informed consent.
What protected health information do the researchers want to use?  All medical information, including but not 
limited to information and/or records of any diagnosis or treatment of disease or condition, which may include 
sexually transmitted diseases (e.g., HIV, etc.) or communicable diseases, drug/alcohol dependency, etc.; all 
personal identifiers, including but not limited to your name, social security number, medical record number, date of 
birth, dates of service, etc.; any past, present, and future history, examinations, laboratory results, imaging studies 
and reports and treatments of whatever kind, including but not limited to drug/alcohol treatment, 
psychiatric/psychological treatment; financial/billing information, including but not limited to copies of your medical 
bills,  and any other information related to or collected for use in the research protocol, regardless of whether the 
information was collected for research or non-research (e.g., treatment) purposes.
Who will disclose, use and/or receive my protected health information?  All Individuals/entities listed in the 
informed consent documents, including but not limited to, the physicians, nurses and staff and others performing 
services related to the research (whether at UAB or elsewhere); other operating units of UAB, HSF, UAB 
Highlands, Children’s of Alabama, Eye Foundation Hospital, and the Jefferson County Department of Health, as 
necessary for their operations; the IRB and its staff; the sponsor of the research and its employees and agents, 
including any CRO; and any outside regulatory agencies, such as the Food and Drug Administration, providing 
oversight or performing other legal and/or regulatory functions for which access to participant information is 
required.
How will my protected health information be protected once it is given to others?  Your protected health 
information that is given to the study sponsor will remain private to the extent possible, even though the study 
sponsor is not required to follow the federal privacy laws. However, once your information is given to other 
organizations that are not required to follow federal privacy laws, we cannot assure that the information will remain 
protected.
How long will this Authorization last?  Your authorization for the uses and disclosures described in this 
Authorization does not have an expiration date.
Can I cancel this Authorization?  You may cancel this Authorization at any time by notifying the Principal 
Investigator, in writing, referencing the research protocol and IRB Protocol Number. If you cancel this 
Authorization, the study doctor and staff will not use any new health information for research. However, 
researchers may continue to use the protected health information that was provided before you cancelled your 
authorization. Can I see my protected health information?  You have a right to request to see your protected 
health information. However, to ensure the scientific integrity of the research, you will not be able to review the 
research information until after the research protocol has been completed.
Signature of participant: 
Date: _ ________
or participant's legally authorized representative: 
Date: __________ 
Printed Name of participant’s representative: 
Relationship to the participant: 

Prot_004.pdf: 
Integration of Evidence-based Alcohol Intervention into HIV 
Care (ARCH-IRA) 
 
 
Study Protocol 
 
NCT02938377 
 
 
May 23, 2019 
 
 
Karen Cropsey, Psy.D, Professor, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 


Version Date:   5/23/2019 
Page 1 
 
 
 
Integration of Evidence-based Alcohol Intervention into HIV Care (ARCH-IRA) 
 
Study Protocol 
 
Version  5 
 May 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Send Questions or Comments to: 
Sarah Dougherty sarahdougherty@uabmc.edu  
Michael Mugavero mmugavero@uabmc.edu 
Karen Cropsey kcropsey@uabmc.edu 
 
 


Version Date:   5/23/2019 
Page 2 
STUDY OBJECTIVES    
 
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use disorder 
(AUD) symptoms.  
Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease 
drinking quantity and or frequency compared to pre-algorithm levels.   
Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD 
symptoms compared to pre-algorithm symptoms levels.  
 
Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related 
outcomes.  
Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits 
and HIV medications compared to pre-algorithm levels.   
Hypothesis 2B.  Patients who receive algorithm-guided treatment will have improved HIV biomarkers 
(e.g., CD4 and viral load (VL)).  Hypothesis 2C.  There will be a positive relationship between VL and 
alcohol consumption measured by self-report and PeTH level. 
 
Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, 
hepatitis C virus coinfection (HCV), and other drug use disorders).   
Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving 
algorithm–guided treatment will have better alcohol, mental health and HIV treatment outcomes 
compared to similar individuals in Standard of Care (SC).  
Hypothesis 3B: PLWH with comorbid HCV receiving algorithm–guided treatment will have improved FIB4 
results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug 
use will decrease among those receiving algorithm-guided treatment vs SC. 
 
Aim 4: Characterize provider-, staff-, patient-, and clinic-level facilitators and barriers to integration of 
algorithm-guided alcohol treatment. We will examine the impact of factors such as provider knowledge and 
confidence, geographic setting, and clinic characteristics such as size, staffing patterns (e.g., number and type of 
staff, providers, etc.), average number of annual visits by patients, amount of Ryan White funding, and average 
appointment time. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Version Date:   5/23/2019 
Page 3 
STUDY ACTIVITIES  
 
I. 
Study Population 
About 756 participants will be recruited from 4 participating study sites (UAB, UW, UCSD, and JHU) over a 
2-year enrollment period. The approximate number of participants enrolled at UAB would be 259, UW 
would be 115, UCSD would be 232, and JHU would be 150. Sites may over enroll if needed.  
 
Inclusion criteria: 
1. Age 18 years or older 
2. Engaged in HIV care at one of the CNICS sites and enrolled in CNICS 
3. The most recent AUDIT-C score ≥3 or 4 for women / ≥4 or 5 for men and MINI ≥1, or AUDIT score ≥5 
for women and ≥6 for men. For patients who identify as transgender, the female scoring cut off for 
AUDIT-C/AUDIT will be used. 
4. English speaking 
5. Able and willing to provide informed consent 
 
Exclusion criteria: 
1. Non-English speaking;  
2. Suicidal ideation as measured by answering item #9 of PHQ 9 “almost every day” which triggers the 
CNICS suicidal ideation pager alert. This is from most recent PRO (same as AUDIT-C and AUDIT scores). 
Having answered PHQ9 with “almost every day” on prior PHQ-9 item #9 in the distant past does not 
meet exclusion criteria.  
3. Unable to provide informed consent.   
4. Provider refusal 
 
II. 
Screening 
Patients who are eligible to take the CNICS PRO on the same day as their Primary Care Provider (PCP) visit 
will be screened for the ARCH IRA study based on the inclusion criteria mentioned above. The CNICS PRO 
will indicate if the patient is eligible/ineligible for the study. 
  
A. AUDIT and AUDIT-C Eligibility Information  
The ARCH-IRA study will use the most recent AUDIT-C or AUDIT score to determine continued eligibility.  
A lower cutoff was selected to be more inclusive and maximize recruitment of potentially eligible 
participants.  This choice is justified as people often under-report bad or socially undesirable behaviors 
such as risky sex, drug, and alcohol use.  
 
 
 
 
 
 
 
 
 
 
 
Women / Transgender 
Men 
AUDIT-C 
≥3 or 4 and MINI ≥1 
≥4 or 5 and MINI ≥1 
AUDIT 
≥5 
≥6 


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Page 4 
Example of continued eligibility:  
Jane scored a 4 on the AUDIT-C and a 2 on the MINI on her PRO. After a page was received 
(please see page XXX for more information on pages), ARCH-IRA study staff approaches Jane in 
clinic. Jane decided to postpone enrollment until her next clinic visit in 6 months. Jane will need 
to complete a new PRO at her clinic visit in 6 months.  
• 
If she does not complete a PRO during her clinic visit, the ARCH-IRA study staff can still 
approach for enrollment into ARCH-IRA.  
• 
If she does complete a PRO during her clinic visit and she her new AUDIT-C score is a 2, 
then Jane is no longer considered eligible for ARCH-IRA and study staff will not 
approach.  
• 
If she does complete a PRO during her clinic visit and she her new AUDIT-C score is a 6 
and study staff received a new Peedy page, then Jane can be approached again for 
enrollment.  
 
III. 
Randomization 
Randomization will be programmed into the CNICS PRO platform. Controls will not be approached for any 
study activity. Study staff will receive pages for only intervention participants. Randomization process 
occurs before the consenting takes place. It is a 5:1 assignment for intervention and controls. Intervention 
vs. control status will be tracked in the PRO platform.  
 
IV. 
Peedy alerts 
If a patient meets the eligibility criteria (page XXX) for ARCH-IRA, a Peedy alert is generated through the 
CNICS PRO platform, which is developed and run by the UW team. A Peedy alert can come through as a 
page and/or an email to the appropriate study staff. Each page and/or email sent will include the 
following: patient’s ticket number (ticket generated through CNICS, valid only 48 hours); the PRO session 
number; and the version of Peedy the patient is eligible for (please refer to page XXX for more information 
on the different versions of Peedy).  
 
A. UAB 
Study staff will approach eligible patients in clinic after receiving the Peedy alert. Staff will follow the 
ARCH-IRA recruitment script (Appendix 3) when approaching in clinic.  
 
B. UW 
The UW will use the same script and approach as UAB and will document status including refusals and 
reasons in the tracking log/PRO platform. (**Note at UW: there is likely not a handoff between two staff 
members as described above for UAB but instead the same staff member will proceed with the consent 
process if the participant is willing.) 
 
C. UCSD 
TBD 
 
D. JHU 
TBD 
 
 
 
 


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Page 5 
V. 
Enrollment and Informed Consent 
Informed consent will be obtained from the patient prior to participation in any study-related activities. 
Only trained study personnel with appropriate Human Subjects training will review and explain the 
consent form and study participation with potential enrollees. Study staff will ensure that the participant 
understands that their consent is voluntary to avoid coercion. Patients will be approached in private rooms 
or designated study space for informed consent procedures by trained study staff. ARCH-IRA study staff at 
all sites will follow their site’s IRB guidance for obtaining informed consent.  
VI. 
Interventions 
A. Peedy video versions 
i. 
Visit 1 
For visit 1, participants can be eligible for Peedy Prime or Peedy Pharma. Peedy Prime is for 
participants who report heavy or binge drinking on the AUDIT-C but do not meet Alcohol 
Use Disorder (AUD) criteria based on the MINI. Peedy Pharmacotherapy (aka Peedy Pharma) 
is for participants who meet criteria for AUD at visit 1 or have a PHQ5 > 5 or PHQ9 > 10. A 
Peedy satisfaction survey will automatically follow all of the video versions. 
ii. Visit 2 
For visit 2, participants can be eligible for Peedy Prize, Peedy Problem, or Peedy Adherence. 
Peedy Prize is for participants who have reduced their drinking from Visit 1 to low-risk limits. 
Peedy Problem is for participants who received Peedy Prime on Visit 1 and continue to 
report risky drinking. Peedy Adherence is for participants who received Peedy Pharma 
during Visit 1 and are still reporting risky drinking. A Peedy satisfaction survey will 
automatically follow all of the video versions. 
 
B. Text Messages 
During visit 1, all participants are eligible to receive text messages that reinforce content from the 
intervention. Please explain that the texts do not contain any personal information and none of the 
content can be traced back to the participant, but the texts do suggest ways to cut down on alcohol. 
 
For participants who opt-in to receive the text messages, study staff will refer to steps #6-10 under 
“Logging into Peedy” on page XX.  It is critical to enter the correct phone number to ensure that 
participants receive the texts and guarantee that the intervention is linked to the correct cellphone. 
 
For participants who do not opt-in to receive text messages, study staff should ask for a reason(s) as to 
why and document that reason in the local study log. Possible reasons for participants to refuse text 
messages: 
I don't have a cell phone 
I don’t want to receive any text messages 
I don’t want to use my data/minutes 
I am concerned text messages will be seen by others 
I don’t think text messages about my alcohol will help me with my drinking 
I don’t like to receive text messages 
I don’t carry my phone with me and would not get texts on time 
I don’t believe I need help with my drinking 
Other: _______________________ 


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C. CBT4CBT 
i. 
Visit 1 
During visit 1, participants who have PHQ5 ≥ 5 and/or PHQ9 ≥ 10 or have AUD on MINI would also 
would become eligible to receive CBT4CBT (Appendix 1 Algorithm 1). A unique CBT4CBT study ID 
would be assigned for each participant through CBT4CBT database.  Study staff would be able to 
track each participant on their completion of CBT4CBT modules.  
 
Patient care coordinator (PCC) and/or study staff will introduce CBT4CBT with participants (please 
see example introduction script below). The study staff and/or PCC will show the participant how to 
login to CB4CBT modules and provide each participant a unique username and password. The study 
staff or PCC will also provide a sheet with the link and login information, worksheets and some 
instructions to the participant (Appendix XX). The study staff and/or PCC will follow-up by phone 
with the participants after about a week to check in and see if they have any issues with completing 
the CBT4CBT modules. Study staff should use an IRB-approved (if applicable) phone script when 
calling participants. (*Note: please check with your site’s IRB to see if you need to have an IRB-
approved phone script or not.) 
 
Example CBT4CBT introduction script: 
“As part of your treatment, we are giving you access to a computerized treatment program that 
you can do at home: CBT4CBT. This program uses cognitive behavioral strategies to help you 
manage cravings to drink and provides effective strategies to reduce or quit drinking. Cognitive 
behavioral therapy is an effective therapy technique that allows you to examine high risk 
situations for drinking and by identifying your thoughts, allows you to counter that thought or 
develop a new way to think about the problem. Thinking about a problem differently often 
influences how you feel, and your subsequent behavior. CBT4CBT has 7 modules about different 
high risk situations and different strategies for how to think about these situations differently so 
that you can make the changes to your drinking. While CBT is traditionally delivered one-on-one 
by a trained therapist, this program uses these same strategies and techniques to teach you the 
skills you need, all at your own pace and in the privacy of your home. The other great thing 
about it is that you can go back and review as many times as you want any of the modules.  It is 
also interactive, so the computer program will ask you questions about high risk situations and 
strategies along the way so you will not just be listening to someone talking; you will be learning 
and applying how to use these techniques. Do you have any questions?”  
Answer any questions that come up, then “Let’s get you started.” 
 
ii. Visit 2 
Before visit 2, study staff/PCC should check the CBT4CBT progress of participants from the monthly 
email the UAB Coordinator sends out. If the participant has not logged in or made much progress 
despite being reminded during the phone call, the study staff/PCC should review login instructions 
and barriers to completion.  Responses should be coded as: 
Unable to access a computer 
Unable to login  
Did not want to do it  
Did not find it helpful  
Too time intensive/long  
I don’t think I need help with my drinking 


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Page 7 
Other, please specify  
 
In instances where PCC cannot meet the participant in clinic, PCC will call participant and follow up 
on progress of CBT4CBT. PCC will make about 6 attempts in a month’s time to reach participant. This 
will be documented in the tracking log maintained separately at each site. 
iii. Generating CBT4CBT Reports 
Monthly, the UAB Coordinator will download a report from CBT4CBT and share it with the 
ARCH-IRA team during the monthly study call.  
Go to: app.cbt4cbt.com/admin 
Enter user name: uabmcD0 
Password: BU6007 
Click Reports, select start and end date and click ‘generate’. 
 
D. Alcohol Pharmacotherapy (APT) 
During visit 1, participants who have scored AUD on MINI would become eligible to receive Alcohol 
Pharmacotherapy (APT). 
 
Providers/PCC/study staff can call/page Pete S. Lane/ Karen Cropsey in case they have questions on 
medications. 
 
Information for Pete S. Lane:  
 
Pager: 205-888-6664   
 
phone number 205-975-3101 
 
Email: pslane@uabmc.edu 
Information for Karen Cropsey: 
 
Phone: 205-975-4204 
 
Cell: 205-514-2025  
 
Email: kcropsey@uabmc.edu 
 
In instances where you cannot reach them by phone and need to leave a VM.   
VM to leave: Hi this is ‘XYZ’, I have a question on ARCH IRA participant who is in the clinic/ or not in 
the clinic (use as appropriate). Please call back at ‘phone number’. 
 
Paging instructions:  
• 
Go to https://www.paging.uab.edu/  
• 
Enter the last 4 digits of the pager number or name in the box and click search. You will see name 
and pager number that pops up.  
• 
Click the pager number which is bold and green and a screen will come up saying enter your 
message and send button.  You can only enter 80 characters for message. 
• 
Enter message and click hit send. 
• 
Message to send: Question on ARCH IRA participant. Call back on ‘phone number’. 
 
i. 
UAB 
Study staff/PCC will use the APT algorithm (Appendix 1 Algorithm 2) and the EMR to determine 
which medication to recommend to the provider. Study staff/PCC will communicate with 
participant’s provider in clinic and/or send a message through the EMR and recommend a drug 
from the APT list. These recommendations will be done based on APT algorithm plus 
consultation with PI (Karen Cropsey) of the study/addiction specialist (Dr. Pete S Lane) on case-


Version Date:   5/23/2019 
Page 8 
by-case basis via email or phone communication. Template scripts of these recommendations 
can be found in Appendix XX.  
 
If APT is prescribed to the participant, study staff/PCC will communicate with participant about 
the side effects of the recommended drug (described in Appendix 2 under medication list) and 
make sure that the participant understands to call study staff/PCC and clinical care team in case 
s/he experiences any side effects. In addition, study staff/PCC will follow up with participants in 
one week to see how they are doing on their medication. Attempts will be made up to one 
month following receipt of medication. Study staff/PCC will call twice per week in attempting to 
reach the participant. If participant reports a side effect, the study staff/PCC will inform the 
participant’s clinical care team using message center in the Cerner. The provider will determine 
the course of action to be taken (e.g., continue, reduce dose, and discontinue medication). Pete 
S. Lane/ Karen Cropsey will be available for provider to consult about medication. 
 
ii. UW 
A similar set of procedures will be used for most of these steps at the UW.  
 
Providers will receive a notification for patients eligible for APT: 
XX is participating in the ARCH-IRA study and reported at-risk alcohol use on the clinical 
assessment. Based on XX’s risk, he is eligible and would likely benefit from Alcohol 
Pharmacotherapy (APT). Naltrexone is most often recommended for APT unless the patient 
has acute hepatitis or liver failure (LFTs>5x ULN) or is currently using prescribed or illicit 
opioids. The dose of naltrexone is 50 mg PO per day.  We have attached an APT medication 
algorithm and list of medications and doses for your information. We hope this information 
is useful to you and that you consider whether prescribing APT would be of benefit to 
George.  
 
At UW, this message can be sent through Epic with algorithm attached or printed and handed 
directly to provider. The assessment of appropriateness of specific APT choices based on LFTs or 
opiate use will be assessed by and at the discretion of the patient provider. The PCC will contact 
participants as above and address issues with participant regarding access, receipt of, and other 
issues with APT but side effects will be deferred to clinical staff. 
 
iii. UCSD 
TBD 
 
iv. JHU 
TBD 
 
E. Dried Blood Spots 
Blood spots will be done after consent on the same day the participant takes the CNICS PRO (visit 1) and 
at ~4-6 months (visit 2).  If participant postpones blood spot on the same day of PRO, participants may 
not have option to come later for a blood spot. These blood spots will be created using 0.5 ml of blood 
and will be used to measure phosphatidylethanol (PeTH) levels.  
 


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Page 9 
Blood spots will be processed by USDTL (United States Drug Testing Laboratories, Inc) located in Des 
Plaines, IL. Sites will send the list of supplies they need to order for creating blood spot cards to UAB. 
Tracey Manley at UAB will assist with processing the orders (PO# 2055670). A supply order form will be 
completed at UAB and sent to USDTL via email (supplies@usdtl.com) or Fax (847.375.0775).  
 
Blood spot cards will be shipped to USDTL in batches (10 or more spot cards). Sites will complete the 
drug sample submission form provided by USDTL and send it along with the spot card batches and save 
a copy for themselves at their site. 
 
i. 
UAB 
A 2ml plastic tube will be added to the CNICS blood draw at the UAB 1917 clinic lab. This blood 
will then be transported by lab staff to the vaccine clinic on 3rd floor of the 1917 clinic where 
the spot cards will be created and stored by the phlebotomy staff members.   Spot cards will 
then be sent to the lab for processing in batches. Preferably, batches must be in 10 or greater 
and packing instructions and materials will be provided by USDLT. REPO #, ARCH study id, Date 
and Time will be on the labels on the samples that will be shipped to the lab. All results will be 
accessed using web portal with unique login credentials assigned to study staff. 
 
ii. UW 
Study staff will notify Linsday Legg (CFAR Research Nurse Coordinator) of UW PEEDY participants 
who complete the PRO that day. The patient will be notified that this is an opportunity to enrich 
the results from this study in terms of how to help patients with HIV who drink alcohol for an 
additional ancillary study and that they will receive $5.00 if they agree to the finger prick. 
 
iii. UCSD 
TBD 
 
iv. JHU 
TBD 
 
F. Logging into Peedy 
1. Go to: https://www.interva-online.mobi/UAB/login.jsp  
2. Log-in: enter username/password and click “Login.” (If you do not have a login, please contact Heidi 
Hutton) 
3. Under “Package” select the appropriate Peedy version to be administered using the drop-down 
arrow. (*Note: For Peedy Pharma, please select “2_V1 : Peedy Pharma”) 
4. Once you select the package, other text fields will appear (Participant ID, First Name, Last Name, 
Staff Initials, etc.). The only field required is the Staff Initials.  
5. Under “Type,” “Real” will be the default selection. If you are testing the system, then change this 
field to “Practice” using the drop down box. If the participant agrees to the text messages, please 
continue to #6. If the participant does not agree to the text messages, please skip #X-X. (Please refer 
to page XX for more information on text messages) 
6. Under “Phone number” type in the participants phone number starting with 1. Do NOT include any 
dashes. 
7. Under “Opt-In Frequency”, select the frequency of the text messages. (*Note: Frequency can only 
be 2, 3, or 4 times per week even though other options are listed) 


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Page 10 
8. Under “Opt-in days”, uncheck the boxes for the days that the participant will NOT receive text 
messages.  Leave checked the days that the participant WILL receive text messages. 
9. Under “Opt-in times”, uncheck the boxes for the times that the participant will NOT receive text 
messages.  Leave checked the times that the participant WILL receive text messages. 
10. Under “Your time zone”, select the appropriate time zone.  
11. Click “Login.” 
12. The Peedy ID (5-digit number also known as the Participant ID) will appear on the next page. Write 
down the Peedy ID on a piece of paper and click “Next.” 
13. Under “Study ID #Entry 1”, you will enter in the Peedy ID that you just wrote down. Click “Submit.” 
14. Under “Study ID #Entry 2”, you will enter in the same Peedy ID from “Study ID #Entry 1.” Click 
“Submit.” 
15. Select the gender of the participant.  
16. On the next page, select the study site you are located at.  
17. On the next page, you will select if the participant is eligible for CBT or not. (For more information 
on CBT, please refer to page XX) 
18. The program will now launch. 
 
G. Visit 3 
Visit 3 is a normal CNICS PRO during the participant’s PCP appointment at each site. No further 
intervention.  
 
VII. 
Documenting in CNICS 
After the initial Peedy alert is generated for a patient, an “ARCH-IRA Study Information” section will appear 
in the patient’s CNICS patient page. This section is to document that patient’s ARCH-IRA study status. 
Regardless of what happened with the alert, you will need to update this section for ARCH-IRA.  
There are 4 events under “Protocol History” that you can choose from:  
Eligible – not approached 
Postponed consent 
Approached refused, not okay to re-approach 
Consented  
After selecting the event that best fits your situation, click “Add New Event” in order for it to save.  
 
After consenting a participant for ARCH-IRA and after updating the Protocol History to show “Consented,” a new 
drop-down will appear for Visit 1. After the participant either completes all or some of Visit 1 or refuses to 
complete Visit 1, you will update the “Protocol History” with the following options: 
Visit 1 drop-down options: 
Withdrawn 
Viewed video 1 Peedy Prime  
Viewed video 1 Peedy Pharma 
Refused video 1 
Refused CBT4CBT 
Refused Pharmacotherapy 
Completed Visit 1 
 
Visit 2 drop-down options: 
Withdrawn 
Eligible – not approached (Video 2) 


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Page 11 
Postpone Video 2 
Viewed video 2 Peedy Adherence 
Viewed video 2 Peedy Problem 
Viewed video 2 Peedy Prize 
Refused video 2 
Refused CBT4CBT 
Refused Pharmacotherapy 
Completed Visit 2 
 
 
 
 
 
 
 
 
 
 
 
 
 


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APPENDIX 1 
 
Algorithm 1. Overall study algorithm 
 
 
 
 
 
 


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Page 13 
 
Algorithm 2. APT algorithm 
 
Yes 


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Page 14 
APPENDIX 2  
APT –Medication List 
 
 
 
Name 
Method 
Dosage 
Side Effects 
Campral 
(acamprosate) 
Tablet 
Two 333mg tablets 
3x/day with or 
without food.  Some 
patients may 
require a lower 
dose.   
Common side effects:  abdominal pain, appetite change, 
change in sexual desire, diarrhea, dry mouth, gas, itchy 
skin, nausea, nervousness, prickling or tingling  
sensation, skin rash, trouble sleeping, vomiting, 
weakness, weight gain or loss 
 
More serious side effects:  chest pain, joint pain, 
pounding or fast heartbeat, symptoms of depression, 
and thoughts or acts of self-harm    
 
Other:  Does not help with alcohol withdrawal 
Disulfiram 
(antabuse) 
Tablet 
250mg or 500mg 2 
or 3x/day   
Common side effects:  skin rash, mild headaches, 
metallic taste, mild weakness, dizziness, swollen tongue 
 
More serious side effects:  allergic reactions (swelling of 
lips, face) and hives, shortness of breath, seizure, 
tiredness, yellowing of skin or eyes, dark urine, appetite 
changes, dizziness, vomiting, weakness, severe diarrhea 
 
Other:  Produces unpleasant effects if you drink alcohol 
while taking it   
Vivitrol (PO 
naltrexone) 
Tablet 
50 mg 1x/day with 
food 
Common side effects:  nausea, vomiting, stomach pain, 
diarrhea, constipation, loss of appetite, headache, 
dizziness, anxiety, nervousness, irritability, tearfulness, 
difficulty sleeping, increased or decreased energy, 
drowsiness, muscle or joint pain, rash  
 
More serious side effects: confusion, hallucinations, 
blurred vision, severe vomiting and/or diarrhea 
 


Version Date:   5/23/2019 
Page 15 
Opioid list as prescribed in Cerner at UAB 
 
Opiates 
acetaminophen/butalbital/caffeine/codeine 
acetaminophen-codeine                    
acetaminophen-HYDROcodone                
acetaminophen-oxycodone                  
acetaminophen-tramadol                   
APAP/butalbital/caffeine/codeine         
APAP/caffeine/dihydrocodeine             
aspirin/butalbital/caffeine/codeine 
aspirin-oxycodone                        
bupivacaine-fentanyl 200 mL              
bupivacaine-fentanyl 250 mL              
bupivacaine-HYDROmorphone 250 mL         
buprenorphine                            
buprenorphine-naloxone                   
butorphanol                              
chlorpheniramine/hydrocodone/phenylephri 
chlorpheniramine/hydrocodone/phenylephrine 
chlorpheniramine-hydrocodone             
codeine                                  
codeine/guaifenesin/PSE                  
codeine/guaiFENesin/pseudoephedrine 
codeine/phenylephrine/promethazine       
codeine-guaifenesin                      
codeine-promethazine                     
dexbrompheniramine/hydrocodone/phenyleph 
dexbrompheniramine/hydrocodone/phenylephrine 
dihydrocodeine/guaiFENesin/phenylephrine 
diphenhydramine/hydrocodone/phenylephrine 
fentanyl                                 
fentanyl 1 
fentanyl 1,000 mcg [0.5 mcg/kg/hr] + dex 
fentaNYL 2 
fentaNYL 2,500 mcg [100 mcg/hr] + empty 
fentaNYL 2,500 mcg [100 mcg/hr] + empty sterile container for IV fluids 50 mL 
fentanyl 2,500 mcg [200 mcg/hr] + empty 
fentaNYL 2,500 mcg [25 mcg/hr] + empty s 
fentaNYL 2,500 mcg [25 mcg/hr] + empty sterile container for IV fluids 50 mL 


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fentaNYL 2,500 mcg [50 mcg/hr] + empty sterile container for IV fluids 50 mL 
fentanyl 2,500 mcg [75 mcg/hr] + empty s 
fentanyl 2,500 mcg [75 mcg/hr] + empty sterile container for IV fluids 50 mL 
fentanyl 2500 mcg + empty sterile contai 
fentaNYL 5 
fentaNYL 5,000 mcg [1 mcg/hr] + empty st 
fentaNYL 5,000 mcg [1 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentaNYL 5,000 mcg [10 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentaNYL 5,000 mcg [100 mcg/hr] + empty 
fentaNYL 5,000 mcg [100 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentaNYL 5,000 mcg [150 mcg/hr] + empty 
fentaNYL 5,000 mcg [150 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentaNYL 5,000 mcg [200 mcg/hr] + empty 
fentaNYL 5,000 mcg [200 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentanyl 5,000 mcg [25 mcg/hr] + empty s 
fentaNYL 5,000 mcg [25 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentanyl 5,000 mcg [50 mcg/hr] + empty s 
fentaNYL 5,000 mcg [50 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentanyl 5,000 mcg [75 mcg/hr] + empty s 
fentanyl 5,000 mcg [75 mcg/hr] + empty sterile container for IV fluids 100 mL 
fentanyl 5000 mcg [50 mcg/hr] + dextrose 
fentanyl-ropivacaine 250 mL 
guaifenesin/hydrocodone/phenylephrine    
guaifenesin-hydrocodone                  
homatropine-hydrocodone                  
HYDROcodone 
HYDROcodone/phenylephrine/pyrilamine 
hydrocodone-ibuprofen                    
hydrocodone-pseudoephedrine              
HYDROmorphone                            
ibuprofen-oxycodone                      
meperidine                               
meperidine-promethazine                  
methadone                                
morphine                                 
morphine 250 mg [1 mg/hr] + Diluent for  
morphine 250 mg [2 mg/hr] + Diluent for  
morphine 30 mg [2 mg/hr] + Diluent for P 
morphine-naltrexone                      
nalbuphine                               


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opium                                    
oxycodone                                
oxymorphone                              
tapentadol                               
traMADol                                 
fentaNYL 5,000 mcg [100 mcg/hr] + Diluent for Premix 100 mL 
fentaNYL 5,000 mcg [150 mcg/hr] + Diluent for Premix 100 mL 
fentaNYL 5000 mcg [150 mcg/hr] + Diluent for Premix 100 mL 
guaiFENesin/HYDROcodone/pseudoephedrine 
Paregoric Liquid                         
Acetaminophen; Tramadol                                      
acetaminophen-hydrocodone                                    
buprenorphine 
codeine syrup 5mg/ml                                         
Duragesic patch                                              
HYDROCO/APAP 
hydrocodon 10/500                                            
Hydrocodone 
hydrocodone 10mg                                             
Hydrocodone 10mg - 325 mg 
loratab 
Lortab                                                       
Lortab 7.5 mg                                                
methadone 
methadone 100 mg daily                                       
morphine                                                     
morphine sulfate                                             
ms contin 300mg every 8 h                                    
Norco                                                        
Norco 7.5mg/325mg                                            
Norco oral four times a 
Opium Tincture                                               
Paregoric Liquid 
percocet does unknown                                        
Suboxone Troche 
tramadol 325mg-37.5mg tid                                    
Tussionex 
Tussionex tablets                                            
Virtussin 
Hydrocodone-Apap 10/500mg every 4hr prn 


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lortab                                                                                                                                                 
Morphine-sul er 60 mg 3 tabs BID 
tylenol #4 taken as 
needed                                                                                                                             
 
 
 


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Page 19 
Medications Containing Alcohol
 


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APPENDIX 3 
In Person ARCH Recruitment Script: 
After your standard introduction… 
 
Based on your answers on the computer/iPad survey you just took, I wanted to talk to you about a 
research study you might be eligible for today. 
 
The study involves watching a 15-20 minute video about alcohol and how it can affect HIV.   There also 
are additional components of alcohol intervention that may be available during the study; you can 
make decisions about how much you would like to do. 
 
For patients who watched Peedy video in round 1 
 
While you may have seen a video in the past about your alcohol use, this is a new study that has some 
additional interventions that may help you with your drinking. 
 
 “Are you interested in participating in this study? 
 
If participant responds ‘Yes’ notify recruitment staff to come and proceed with consent process. 
 
If participant responds ‘No’, notify recruitment staff and provide as much detail regarding refusal as you 
can.  Patients who refuse to participate will be informed that this is not a requirement for their care and 
that their relationship with the 1917 Clinic will not be affected in any way.  Ask patient “may we contact 
you again”.  If you receive a definite “NO”, communicate this to study staff and we will not approach this 
patient in the future. Study staff will make a note of this in the tracking logs and record reasons of 
decline on the tracking log. The following are the options available for decline: 
 
Already did Peedy before 
 
Not interested 
 
I don’t want to change 
 
Don’t have time 
 
Unable to understand/speak English 
 
I don’t trust research studies 
I don’t feel well enough today to do it 
I need to get my partner’s permission first 
Getting support from other sources 
I don’t have an alcohol problem 
Other reason not listed 
 
 
 
 
 
 
 
 
 
 


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Page 22 
 
APPENDIX 4 
 
ARCH IRA Getting Started and Troubleshooting Guide 
 
 
Link: 
http://www.cbt4cbt.com/  
 
User name: 
 
 
 
 
 
 
 
Password: 
 
 
 
 
 
  
 
Getting Started 
To begin, you will log on to the link above, go to portal for clients, enter your login credentials - username and password 
provided to you.  There will be a video for you to watch in order to check that the videos are working with your device and 
that sound is playing.  If everything is working, click “Continue to Main Site” once.  Read the next page and click “Continue 
to Main Site” again.  From there, begin the first topic, called “Recognize the Triggers” by clicking on it from the top of the 
page. 
 
The first video that plays will be a quick guide to using the program.  If you have any trouble, you can return to this video to 
review it. 
 
The program is made up of a combination of videos to watch and activities to complete, as well as some text messages that 
will be sent to your phone over the course of the program.  Please pay close attention to the videos and to any instructions for 
the activities. 
 
You can use the ‘worksheets’ provided to you for the activities listed in the modules.  
 
Troubleshooting Guide 
The video or activity is not loading. (There is a black box where the video should be.) 
Try refreshing the page when something does not load.  You can do this by either using your browser’s refresh button or the 
“Restart Page” button below the video or activity.  Sometimes, an entire topic will have trouble loading.  If this happens, 
click on the “Restart Topic” button and try again. 
 
The video looks like it has loaded, but nothing is happening. 
On some devices, you have to click or tap on the video to get it to start.  If it does not start afterwards, click on the “Restart 
Page” button and try again. 
 
How do I go to the next page? 
Within each module, you can move forwards or backwards using the small, blue arrows in the bottom left corner. 
 
I have finished a topic.  How do I go to the next one? 
When you have finished a topic, click on the “Back to Topics Selection page” link at the top of the page.  From there, you 
can choose the next topic from the middle of the page, or from the “Recommended Order” list on the left of the page. 
 
I am not sure what to do for this activity. 
For each activity, a short explanation will play before you begin.  If you missed this explanation or would like to hear it 
again, click on the “Restart Page” button at the bottom of the page. 
 
The program has me watch the same video several times. 
While there are many videos in the program that are similar, there are small differences between each one.  These differences 
may include changes to what people say, how they behave in different situations, or what they are thinking.  Pay close 
attention to these differences, as they are usually there to show how changing your behaviors can change the situation. 
  
 


Version Date:   5/23/2019 
Page 23 
Appendix 5 
APT scripts template at UAB for these recommendations will be: 
Message to Fellow/Nurse Practitioner  CC Attending, Michael Mugavero, Pete S Lane, Karen Cropsey, in 
IMPACT Message Center: INTERVENTION PARTICIPANTS 
 
 
If Naltrexone Prescription 
 
Subject: ARCH IRA study  
Pt enrolled to ARCH IRA study: U01 AA020802 - Alcohol Research Consortium on HIV – Intervention 
Research Consortium  
Enrolled on xx/xx/xxxx, with a AUDIT/AUDIT C score of XX  
Patient name scored >=4 on MINI on CNICS PRO (date xx/xx/xxxx) and is eligible for the CBT4CBT 
(Computer Based Training for Cognitive Therapy) and APT intervention components. Based on study 
algorithm and consultation with Dr. Pete S. Lane/ Dr. Karen Cropsey we recommend a prescription of 
tablet naltrexone 50 mg 1x/day with food. There were no chronic or current opioids listed and no LFTs 
>5xULN on medical record for this patient (checked on date: xx/xx/xxxx). We have also confirmed with 
participant about illicit opioid use since naltrexone may interact with opioids.  
ARCH IRA study staff: Name 
 
OR 
 
Subject: ARCH IRA study  
Pt enrolled to ARCH IRA study: U01 AA020802 - Alcohol Research Consortium on HIV – Intervention 
Research Consortium  
Enrolled on xx/xx/xxxx, with a AUDIT/AUDIT C score of XX  
Patient name scored >=4 on MINI on CNICS PRO (date xx/xx/xxxx) and is eligible for the CBT4CBT 
(Computer Based Training for Cognitive Therapy) and APT intervention components. Based on study we 
recommend a prescription of tablet naltrexone 50 mg 1x/day with food. There were no chronic or 
current opioids listed and no LFTs >5xULN on medical record for this patient (checked on date: 
xx/xx/xxxx). We have also confirmed with participant about illicit opioid use since naltrexone may 
interact with opioids.  
ARCH IRA study staff: Name 
 
If Acomprosate Prescription 
 
Subject: ARCH IRA study  
Pt enrolled to ARCH IRA study: U01 AA020802 - Alcohol Research Consortium on HIV – Intervention 
Research Consortium  
Enrolled on xx/xx/xxxx, with a AUDIT/AUDIT C score of XX  
Patient name scored >=4 on MINI on CNICS PRO (date xx/xx/xxxx) and is eligible for the CBT4CBT 
(Computer Based Training for Cognitive Therapy) and APT intervention components. Based on study 
algorithm and consultation with Dr. Pete S. Lane/ Dr. Karen Cropsey we recommend a prescription of 
tablet acomprosate Two 333mg tablets 3x/day with or without food. The CrClearance was not <30 on 
medical record for this patient (checked on date: xx/xx/xxxx).  
ARCH IRA study staff: Name 
 
OR 


Version Date:   5/23/2019 
Page 24 
 
Subject: ARCH IRA study  
Pt enrolled to ARCH IRA study: U01 AA020802 - Alcohol Research Consortium on HIV – Intervention 
Research Consortium  
Enrolled on xx/xx/xxxx, with a AUDIT/AUDIT C score of XX  
Patient name scored >=4 on MINI on CNICS PRO (date xx/xx/xxxx) and is eligible for the CBT4CBT 
(Computer Based Training for Cognitive Therapy) and APT intervention components. Based on study 
algorithm we recommend a prescription of tablet acomprosate Two 333mg tablets 3x/day with or 
without food. The CrClearance was not <30 on medical record for this patient (checked on date: 
xx/xx/xxxx).  
ARCH IRA study staff: Name 
 
If Disulfiram Prescription 
 
Subject: ARCH IRA study  
Pt enrolled to ARCH IRA study: U01 AA020802 - Alcohol Research Consortium on HIV – Intervention 
Research Consortium  
Enrolled on xx/xx/xxxx, with a AUDIT/AUDIT C score of XX  
Patient name scored >=4 on MINI on CNICS PRO (date xx/xx/xxxx) and is eligible for the CBT4CBT 
(Computer Based Training for Cognitive Therapy) and APT intervention components. Based on study 
algorithm and consultation with Dr. Pete S. Lane/ Dr. Karen Cropsey we recommend a prescription of 
tablet disulfiram 250mg or 500mg 2 or 3x/day. There were no active prescriptions of ritonavir, tipinavir, 
metronidazole or any med containing alcohol on medical record for this patient (checked on date: 
xx/xx/xxxx).  
ARCH IRA study staff: Name 
 
OR 
 
Subject: ARCH IRA study  
Pt enrolled to ARCH IRA study: U01 AA020802 - Alcohol Research Consortium on HIV – Intervention 
Research Consortium  
Enrolled on xx/xx/xxxx, with a AUDIT/AUDIT C score of XX  
Patient name scored >=4 on MINI on CNICS PRO (date xx/xx/xxxx) and is eligible for the CBT4CBT 
(Computer Based Training for Cognitive Therapy) and APT intervention components. Based on study 
algorithm we recommend a prescription of tablet disulfiram 250mg or 500mg 2 or 3x/day. There were 
no active prescriptions of ritonavir, tipinavir, metronidazole or any med containing alcohol on medical 
record for this patient (checked on date: xx/xx/xxxx).  
ARCH IRA study staff: Name