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Alcohol Research in HIV: Relapse Prevention

Alcohol Research Consortium in HIV: Relapse Prevention Arm

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05163301
Acronym
ARCH-RPA
Enrollment
150
Registered
2021-12-20
Start date
2023-03-27
Completion date
2027-05-31
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, HIV

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.

Interventions

2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in time to relapse6 and 12 monthsTime to return to any alcohol use or any at risk alcohol use after intervention.

Secondary

MeasureTime frameDescription
Alcohol use pattern as assessed by change in number of drinking daysBaseline, 6 and 12 monthsNumber of drinking days.
Alcohol use pattern as assessed by change in number of heavy drinking daysBaseline, 6 and 12 monthsNumber of heavy drinking days.
Alcohol use pattern as assessed by change in number of drinks per drinking dayBaseline, 6 and 12 monthsNumber of drinks per drinking day.
Alcohol use pattern as assessed by change in number of days abstinentBaseline, 6 and 12 monthsNumber of days abstinent.

Countries

United States

Contacts

CONTACTHeidi Hutton, PhD
hhutton@jhmi.edu14104586715
PRINCIPAL_INVESTIGATORHeidi Hutton, PhD

Johns Hopkins School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026