Alcohol Research in HIV: Relapse Prevention
ARCH-RPA
Alcohol Research Consortium in HIV: Relapse Prevention Arm
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Mar 2023
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2021
CompletedFirst Posted
Study publicly available on registry
December 20, 2021
CompletedStudy Start
First participant enrolled
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
February 18, 2026
February 1, 2026
3.9 years
December 6, 2021
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in time to relapse
Time to return to any alcohol use or any at risk alcohol use after intervention.
6 and 12 months
Secondary Outcomes (4)
Alcohol use pattern as assessed by change in number of drinking days
Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of heavy drinking days
Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of drinks per drinking day
Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of days abstinent
Baseline, 6 and 12 months
Study Arms (3)
Computer delivered RPI
EXPERIMENTAL2 session computer delivered counseling to prevent relapse to hazardous drinking
Person delivered RPI
EXPERIMENTAL2 session counselor delivered counseling to prevent relapse to hazardous drinking
Treatment as Usual
NO INTERVENTIONCounseling for alcohol use available in clinic as treatment as usual
Interventions
2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
- Non-English speaking because interventions are currently available in English only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi Hutton, PhD
Johns Hopkins School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2021
First Posted
December 20, 2021
Study Start
March 27, 2023
Primary Completion (Estimated)
February 25, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared with the general research community 2 years after the grant end date on the initial Notice of Award. This 2-year embargo period will provide study investigators with protected time to publish from the study data. After the embargo, the data will be made available for sharing with the general research community via the NIAAA DA website. However, if a manuscript using study data is accepted for publication prior to the 2-year embargo, the study data specifically used in that manuscript will be shared with the general research community at the time of publication.
- Access Criteria
- Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAA DA data by submitting a data access request in accordance with applicable NIAAA DA policies. Data requests will be reviewed and granted by a NIAAA Data Access Committee.
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.