Preventing relapse in people with HIV and alcohol use issues
Alcohol Research Consortium in HIV: Relapse Prevention Arm
This study is testing a new counseling program to help people with HIV who have relapsed in their alcohol use to see if it works better than regular alcohol counseling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05163301 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the effectiveness and feasibility of a brief counseling intervention designed for individuals with HIV who have experienced a relapse in alcohol use after a period of abstinence. Participants will receive either a person-delivered or a computer-delivered relapse prevention intervention, which will be compared to standard alcohol counseling provided at the HIV clinic. The study will also assess how acceptable and feasible these interventions are for implementation in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed HIV diagnosis and a history of alcohol use disorder who are currently receiving care at the Johns Hopkins HIV Clinic.
Not a fit: Patients who are acutely suicidal, homicidal, psychotic, or unable to provide informed consent, as well as non-English speakers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help reduce alcohol relapse rates among individuals living with HIV, improving their overall health and quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in addressing alcohol use disorders in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Heidi Hutton, PhD — Johns Hopkins School of Medicine
- Study coordinator: Heidi Hutton, PhD
- Email: hhutton@jhmi.edu
- Phone: 14104586715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.