Alcohol Research in HIV: Relapse Prevention

HIV Clinical Trial

— ARCH-RPA  

Official title:

Alcohol Research Consortium in HIV: Relapse Prevention Arm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163301
• Other study ID #: IRB00288483
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: Heidi Hutton, PhD
• Phone: 14104586715
• Email: hhutton[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• HIV

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alcohol use pattern as assessed by change in number of drinking days	Number of drinking days.	Baseline, 6 and 12 months
Secondary	Alcohol use pattern as assessed by change in number of heavy drinking days	Number of heavy drinking days.	Baseline, 6 and 12 months
Secondary	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
Secondary	Alcohol use pattern as assessed by change in number of days abstinent	Number of days abstinent.	Baseline, 6 and 12 months