Alcohol Research in HIV: Relapse Prevention

Not Applicable

Recruiting

• Conditions: HIV; Alcohol Use Disorder
• Interventions: Behavioral: Relapse Prevention Intervention

• Registration Number: NCT05163301
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-20
• Study Start: 2023-03-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2026-02-01
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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Exclusion Criteria

• Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
• Non-English speaking because interventions are currently available in English only

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer delivered RPI	Relapse Prevention Intervention	2 session computer delivered counseling to prevent relapse to hazardous drinking
Person delivered RPI	Relapse Prevention Intervention	2 session counselor delivered counseling to prevent relapse to hazardous drinking

Primary Outcome Measures

Name	Time	Method
Change in time to relapse	6 and 12 months	Time to return to any alcohol use or any at risk alcohol use after intervention.

Secondary Outcome Measures

Name	Time	Method
Alcohol use pattern as assessed by change in number of drinking days	Baseline, 6 and 12 months	Number of drinking days.
Alcohol use pattern as assessed by change in number of drinks per drinking day	Baseline, 6 and 12 months	Number of drinks per drinking day.
Alcohol use pattern as assessed by change in number of days abstinent	Baseline, 6 and 12 months	Number of days abstinent.
Alcohol use pattern as assessed by change in number of heavy drinking days	Baseline, 6 and 12 months	Number of heavy drinking days.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States