Clinical trial NCT05163301: Alcohol Research in HIV: Relapse Prevention
Official title: Alcohol Research Consortium in HIV: Relapse Prevention Arm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Alcohol Use Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-12-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group will receive computer delivered relapse prevention intervention (RPI); one group will receive person delivered relapse prevention intervention; one group will receive usual care
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in time to relapse
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Alcohol use pattern as assessed by change in number of drinking days
timeFrame: Baseline, 6 and 12 months
measure: Alcohol use pattern as assessed by change in number of heavy drinking days
timeFrame: Baseline, 6 and 12 months
measure: Alcohol use pattern as assessed by change in number of drinks per drinking day
timeFrame: Baseline, 6 and 12 months
measure: Alcohol use pattern as assessed by change in number of days abstinent
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Heidi Hutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: