Alcohol Research in HIV: Relapse Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Relapse Prevention Intervention.
- Who it may be relevant to
- Registry conditions: HIV, Alcohol Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Alcohol Research Consortium in HIV: Relapse Prevention Arm
Overview
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.
Interventions
- Behavioral Relapse Prevention Intervention
2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder
Primary outcome measures
- Change in time to relapse [Time frame: 6 and 12 months]
Secondary outcome measures (4)
- Alcohol use pattern as assessed by change in number of drinking days [Time frame: Baseline, 6 and 12 months]
- Alcohol use pattern as assessed by change in number of heavy drinking days [Time frame: Baseline, 6 and 12 months]
- Alcohol use pattern as assessed by change in number of drinks per drinking day [Time frame: Baseline, 6 and 12 months]
- Alcohol use pattern as assessed by change in number of days abstinent [Time frame: Baseline, 6 and 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins School of Medicine — Baltimore
Identifiers
NCT: NCT05163301 · IRB00288483