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

Johns Hopkins University

Status: Enrolling

Conditions: HIV; Alcohol Use Disorder

Treatments: Behavioral: Relapse Prevention Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05163301

IRB00288483

Details and patient eligibility

About

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 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

Computer delivered RPI

Experimental group

Description:

2 session computer delivered counseling to prevent relapse to hazardous drinking

Treatment:

Behavioral: Relapse Prevention Intervention

Person delivered RPI

Experimental group

Description:

2 session counselor delivered counseling to prevent relapse to hazardous drinking

Treatment:

Behavioral: Relapse Prevention Intervention

Treatment as Usual

No Intervention group

Description:

Counseling for alcohol use available in clinic as treatment as usual