Alcohol Research in HIV: Relapse Prevention

Study Overview
=================
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.

Official Title
-----------------
Alcohol Research Consortium in HIV: Relapse Prevention Arm

Conditions
-----------------
HIV, Alcohol Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Relapse Prevention Intervention


Participation Criteria
=================
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: lifetime alcohol use disorder 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) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer delivered RPI<br>2 session computer delivered counseling to prevent relapse to hazardous drinking | Behavioral: Relapse Prevention Intervention<br>* 2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder<br>|
| Experimental: Person delivered RPI<br>2 session counselor delivered counseling to prevent relapse to hazardous drinking | Behavioral: Relapse Prevention Intervention<br>* 2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder<br>|
| No Intervention: Treatment as Usual<br>Counseling for alcohol use available in clinic as treatment as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol use pattern as assessed by change in number of drinking days | Number of drinking days. | Baseline, 6 and 12 months | 
| Alcohol use pattern as assessed by change in number of heavy drinking days | Number of heavy drinking days. | Baseline, 6 and 12 months | 
| 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 | 
| Alcohol use pattern as assessed by change in number of days abstinent | Number of days abstinent. | Baseline, 6 and 12 months |