Recruiting

Relapse Prevention

Sponsor:

Johns Hopkins University

Code:

NCT05163301

Conditions

HIV

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Relapse Prevention Intervention

Study Details

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.

Conditions

HIV

Alcohol Use Disorder

Study ID

NCT05163301

Start date

Mar 27, 2023

Status verified date

Feb, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Feb 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Computer delivered RPI

2 session computer delivered counseling to prevent relapse to hazardous drinking

experimental: Person delivered RPI

2 session counselor delivered counseling to prevent relapse to hazardous drinking

no intervention: Treatment as Usual

Counseling for alcohol use available in clinic as treatment as usual

Interventions

Relapse Prevention Intervention

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

Primary outcome measure

  • Change in time to relapse [ Time Frame: 6 and 12 months ]

Central Contacts and Locations

Central contacts

Heidi Hutton, PhD

14104586715hhutton@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Heidi Hutton, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-18.