HIV PositivePhase 4ARCH-IRANCT02938377
Alcohol Research Consortium in HIV-Intervention Research Arm
A Phase 4 study testing Computerized Brief Intervention (CBI), CBT4CBT and Recommendation and Counseling for Alcohol Pharmacotherapy in people with HIV Positive and Alcohol Use, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Positive, Alcohol Use
- What is being tested?
- Computerized Brief Intervention (CBI), CBT4CBT and Recommendation and Counseling for Alcohol Pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,985 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2017to 1 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, UW or UCSD clinics and not anticipating changing clinics over the next 12 months;
- AUDIT-C score > 3 women or > 4 men at time of PRO.
Who cannot join
- Non-English speaking;
- Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Harborview Medical Center; 2 West Clinic; UW Center for AIDS
Seattle, Washington, 359931
About this study
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
Read the 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.
- Conditions
- HIV Positive, Alcohol Use
- Being tested
- Computerized Brief Intervention (CBI), CBT4CBT, Recommendation and Counseling for Alcohol Pharmacotherapy
- Medical subject headings
- HIV Seropositivity, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Brief Intervention (CBI)Behavioural
Also called CBI
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.
CBT4CBTBehavioural
Also called Cognitive Behavioral Therapy
9 computerized modules delivered at the participant's pace
Recommendation and Counseling for Alcohol PharmacotherapyDrug
Also called Recommendation for APT
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.
| Study group | Role | What they receive |
|---|---|---|
| No dx of alcohol use disorder, panic or depression | Active comparator | Computerized Brief Intervention (CBI)- a video about alcohol abuse Receives: Behavioral: Computerized Brief Intervention (CBI) |
| Risky drinking, no dx of AUD, has panic or depression | Active comparator | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Receives: Behavioral: Computerized Brief Intervention (CBI); Behavioral: CBT4CBT |
| Dx of AUD with or without panic or depression | Active comparator | 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. Receives: Behavioral: Computerized Brief Intervention (CBI); Behavioral: CBT4CBT; Drug: Recommendation and Counseling for Alcohol Pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audit-C Score on a Scale
Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Measured: 18 month window
Secondary outcomes (1)
PEth Levels
PEth is a biomarker for recent alcohol use found in the blood that is specific to ethanol ingestion and can detect low-to heavy drinking levels.
Measured: Between baseline and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start6 Nov 2017
- Primary completion1 Nov 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV PositiveStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were given varying levels of treatment depending on their alcohol use.
- Masking
- None (open label)
- Enrolment
- 4,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Cropsey, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938377
- Sponsor's protocol ID
- F160706007
- Acronym
- ARCH-IRA
- Status last verified
- Feb 2025
- First submitted
- 17 Oct 2016
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Research Consortium in HIV-Intervention Research Arm
- ClinicalTrials.gov ID
- NCT02938377
- Acronym / sponsor ID
- ARCH-IRA / F160706007
- Conditions
- HIV Positive, Alcohol Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,985 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were given varying levels of treatment depending on their alcohol use.
| Arm | Type | Receives |
|---|---|---|
| No dx of alcohol use disorder, panic or depression | Active comparator | Behavioral: Computerized Brief Intervention (CBI)Computerized Brief Intervention (CBI)- a video about alcohol abuse |
| Risky drinking, no dx of AUD, has panic or depression | Active comparator | Behavioral: Computerized Brief Intervention (CBI), Behavioral: CBT4CBTComputerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy |
| Dx of AUD with or without panic or depression | Active comparator | Behavioral: Computerized Brief Intervention (CBI), Behavioral: CBT4CBT, Drug: Recommendation and Counseling for Alcohol PharmacotherapyComputerized 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years or older;
- Receiving HIV care at the UAB, UW or UCSD clinics and not anticipating changing clinics over the next 12 months;
- AUDIT-C score > 3 women or > 4 men at time of PRO.
Key exclusion criteria (2 listed)
- Non-English speaking;
- Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.
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 |
|---|---|---|
| Computerized Brief Intervention (CBI)Also: CBIA 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. | Behavioural | Dx of AUD with or without panic or depression, No dx of alcohol use disorder, panic or depression, Risky drinking, no dx of AUD, has panic or depression |
| CBT4CBTAlso: Cognitive Behavioral Therapy9 computerized modules delivered at the participant's pace | Behavioural | Dx of AUD with or without panic or depression, Risky drinking, no dx of AUD, has panic or depression |
| Recommendation and Counseling for Alcohol PharmacotherapyAlso: Recommendation for APTThe 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. | Drug | Dx of AUD with or without panic or depression |
Primary outcome
Audit-C Score on a Scale
Time frame: 18 month window
Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
1 secondary outcome
PEth Levels
Time frame: Between baseline and 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Computerized Brief Intervention (CBI), CBT4CBT and Recommendation and Counseling for Alcohol Pharmacotherapy in people with HIV Positive and Alcohol Use, run by University of Alabama at Birmingham at 2 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 3 inclusion and 2 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Audit-C Score on a Scale (time frame: 18 month window). 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 10 Mar 2025.