Alcohol Research in HIV: Relapse Prevention

Overview

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.

Full Title of Study: “Alcohol Research Consortium in HIV: Relapse Prevention Arm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 1, 2026

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.

Interventions

  • Behavioral: Relapse Prevention Intervention
    • 2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder

Arms, Groups and Cohorts

  • Experimental: Computer delivered RPI
    • 2 session computer delivered counseling to prevent relapse to hazardous drinking
  • Experimental: Person delivered RPI
    • 2 session counselor delivered counseling to prevent relapse to hazardous drinking
  • No Intervention: Treatment as Usual
    • Counseling for alcohol use available in clinic as treatment as usual

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Alcohol use pattern as assessed by change in number of drinking days
    • Time Frame: Baseline, 6 and 12 months
    • Number of drinking days.
  • Alcohol use pattern as assessed by change in number of heavy drinking days
    • Time Frame: Baseline, 6 and 12 months
    • Number of heavy drinking days.
  • Alcohol use pattern as assessed by change in number of drinks per drinking day
    • Time Frame: Baseline, 6 and 12 months
    • Number of drinks per drinking day.
  • Alcohol use pattern as assessed by change in number of days abstinent
    • Time Frame: Baseline, 6 and 12 months
    • Number of days abstinent.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Heidi Hutton, PhD, Principal Investigator, Johns Hopkins School of Medicine
  • Overall Contact(s)
    • Heidi Hutton, PhD, 14104586715, hhutton@jhmi.edu

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