Alcohol Research in HIV: Relapse Prevention

NCT ID: NCT05163301

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2026-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Computer delivered RPI

2 session computer delivered counseling to prevent relapse to hazardous drinking

Group Type: EXPERIMENTAL

Relapse Prevention Intervention

Intervention Type: BEHAVIORAL

2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder

Person delivered RPI

2 session counselor delivered counseling to prevent relapse to hazardous drinking

Group Type: EXPERIMENTAL

Relapse Prevention Intervention

Intervention Type: BEHAVIORAL

2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder

Treatment as Usual

Counseling for alcohol use available in clinic as treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relapse Prevention Intervention

2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Hutton, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heidi Hutton, PhD

Role: CONTACT

hhutton@jhmi.edu

14104586715

Facility Contacts

Heidi Hutton

Role: primary

Other Identifiers

IRB00288483

Identifier Type: -

Identifier Source: org_study_id