HIVARCH-RPANCT05163301
Alcohol Research in HIV: Relapse Prevention
A study testing Relapse Prevention Intervention in people with HIV and Alcohol Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Alcohol Use Disorder
- What is being tested?
- Relapse Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Confirmed diagnosis of HIV
- Aged 18 years or older
- Must be enrolled in clinical care at Johns Hopkins HIV Clinic.
- In addition, meet the following alcohol use criteria:
- lifetime alcohol use disorder
- patient reported outcomes (PRO) assessment collected by the Center for AIDS Research (CFAR) Network of Clinical Systems as part of usual clinical care that show in the last 3 years: periods of no or lower risk drinking (e.g. women/men who are drinking <11/22 drinks per week) and periods of lapse to higher levels of drinking (=>11/22 drinks per week for women/men)
- current PRO showing alcohol abstinence or alcohol use at <11/22 drinks per week for women/men.
Who cannot join
- Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
- Non-English speaking because interventions are currently available in English only
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Heidi Hutton
Heidi Hutton, PhD
About this study
Official title: Alcohol Research Consortium in HIV: Relapse Prevention Arm
3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention.
Read the detailed description
This study will develop a brief counseling intervention for people with HIV who have resumed alcohol use or resumed hazardous alcohol use after a minimum of 3 years of alcohol abstinence or 'lower risk' alcohol use. The investigators will develop a 2session person delivered and a 2-session computer delivered intervention which the investigators will then compare with the usual treatment for alcohol counseling offered at the HIV clinic. The investigators will also study the acceptability and feasibility of implementing both types of counseling in the clinic.
- Conditions
- HIV, Alcohol Use Disorder
- Being tested
- Relapse Prevention Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relapse Prevention InterventionBehavioural
2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder
| Study group | Role | What they receive |
|---|---|---|
| Computer delivered RPI | Experimental | 2 session computer delivered counseling to prevent relapse to hazardous drinking Receives: Behavioral: Relapse Prevention Intervention |
| Person delivered RPI | Experimental | 2 session counselor delivered counseling to prevent relapse to hazardous drinking Receives: Behavioral: Relapse Prevention Intervention |
| Treatment as Usual | No intervention | Counseling for alcohol use available in clinic as treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to relapse
Time to return to any alcohol use or any at risk alcohol use after intervention.
Measured: 6 and 12 months
Secondary outcomes (4)
Alcohol use pattern as assessed by change in number of drinking days
Number of drinking days.
Measured: Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of heavy drinking days
Number of heavy drinking days.
Measured: Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of drinks per drinking day
Number of drinks per drinking day.
Measured: Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of days abstinent
Number of days abstinent.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start27 Mar 2023
- Primary completion25 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
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 Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group will receive computer delivered relapse prevention intervention (RPI); one group will receive person delivered relapse prevention intervention; one group will receive usual care
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Heidi Hutton, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163301
- Sponsor's protocol ID
- IRB00288483
- Acronym
- ARCH-RPA
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2021
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIAAA has begun a new data-sharing initiative to create a data repository of future NIAAA-funded studies that include human subjects. This repository is called the NIAAA Data Archive (NIAAA DA). NIAAA-funded investigators conducting human subjects research are expected to submit de-identified, individual-level data to this data archive. The NIAAA DA accepts only electronic, de-identified data from human subjects studies. Data submitted to the NIAAA DA must be de-identified by the investigator prior to submission.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Research Consortium in HIV: Relapse Prevention Arm
- ClinicalTrials.gov ID
- NCT05163301
- Acronym / sponsor ID
- ARCH-RPA / IRB00288483
- Conditions
- HIV, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention.
Detailed description
This study will develop a brief counseling intervention for people with HIV who have resumed alcohol use or resumed hazardous alcohol use after a minimum of 3 years of alcohol abstinence or 'lower risk' alcohol use. The investigators will develop a 2session person delivered and a 2-session computer delivered intervention which the investigators will then compare with the usual treatment for alcohol counseling offered at the HIV clinic. The investigators will also study the acceptability and feasibility of implementing both types of counseling in the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- one group will receive computer delivered relapse prevention intervention (RPI); one group will receive person delivered relapse prevention intervention; one group will receive usual care
| Arm | Type | Receives |
|---|---|---|
| Computer delivered RPI | Experimental | Behavioral: Relapse Prevention Intervention2 session computer delivered counseling to prevent relapse to hazardous drinking |
| Person delivered RPI | Experimental | Behavioral: Relapse Prevention Intervention2 session counselor delivered counseling to prevent relapse to hazardous drinking |
| Treatment as Usual | No intervention | –Counseling for alcohol use available in clinic as treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of HIV
- Aged 18 years or older
- Must be enrolled in clinical care at Johns Hopkins HIV Clinic.
- lifetime alcohol use disorder
- patient reported outcomes (PRO) assessment collected by the Center for AIDS Research (CFAR) Network of Clinical Systems as part of usual clinical care that show in the last 3 years: periods of no or lower risk drinking (e.g. women/men who are drinking <11/22 drinks per week) and periods of lapse to higher levels of drinking (=>11/22 drinks per week for women/men)
Key exclusion criteria (2 listed)
- Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
- Non-English speaking because interventions are currently available in English only
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 |
|---|---|---|
| Relapse Prevention Intervention2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder | Behavioural | Computer delivered RPI, Person delivered RPI |
Primary outcome
Change in time to relapse
Time frame: 6 and 12 months
Time to return to any alcohol use or any at risk alcohol use after intervention.
4 secondary outcomes
Alcohol use pattern as assessed by change in number of drinking days
Time frame: Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of heavy drinking days
Time frame: Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of drinks per drinking day
Time frame: Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of days abstinent
Time frame: Baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Yes. NIAAA has begun a new data-sharing initiative to create a data repository of future NIAAA-funded studies that include human subjects. This repository is called the NIAAA Data Archive (NIAAA DA). NIAAA-funded investigators conducting human subjects research are expected to submit de-identified, individual-level data to this data archive. The NIAAA DA accepts only electronic, de-identified data from human subjects studies. Data submitted to the NIAAA DA must be de-identified by the investigator prior to submission.
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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.
Heidi Hutton, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relapse Prevention Intervention in people with HIV and Alcohol Use Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Hutton, PhD (14104586715, hhutton@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to relapse (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.