Alcohol Research in HIV: Relapse Prevention (ARCH-RPA)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: 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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Hutton, PhD; Phone Number: 14104586715; Email: hhutton@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins School of Medicine
      • Contact: Heidi Hutton
      • Principal Investigator: Heidi Hutton, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

1. lifetime alcohol use disorder
2. 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)
3. current PRO showing alcohol abstinence or alcohol use at <11/22 drinks per week for women/men.

Exclusion Criteria:

• Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
• Non-English speaking because interventions are currently available in English only

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer delivered RPI; 2 session computer delivered counseling to prevent relapse to hazardous drinking	Behavioral: Relapse Prevention Intervention; 2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder
Experimental: Person delivered RPI; 2 session counselor delivered counseling to prevent relapse to hazardous drinking	Behavioral: Relapse Prevention Intervention; 2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder
No Intervention: Treatment as Usual; Counseling for alcohol use available in clinic as treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use pattern as assessed by change in number of drinking days	Number of drinking days.	Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of heavy drinking days	Number of heavy drinking days.	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.	Baseline, 6 and 12 months
Alcohol use pattern as assessed by change in number of days abstinent	Number of days abstinent.	Baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Heidi Hutton, PhD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: IRB00288483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No