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NCT Number: NCT05163301

Alcohol Research in HIV: Relapse Prevention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Heidi Hutton

CONTACT

Heidi Hutton, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relapse Prevention Intervention

Behavioral

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

Primary outcomes

  1. Change in time to relapse

    Time frame: 6 and 12 months

    Time to return to any alcohol use or any at risk alcohol use after intervention.

Secondary outcomes

  1. Alcohol use pattern as assessed by change in number of drinking days

    Time frame: Baseline, 6 and 12 months

    Number of drinking days.

  2. Alcohol use pattern as assessed by change in number of heavy drinking days

    Time frame: Baseline, 6 and 12 months

    Number of heavy drinking days.

  3. Alcohol use pattern as assessed by change in number of drinks per drinking day

    Time frame: Baseline, 6 and 12 months

    Number of drinks per drinking day.

  4. Alcohol use pattern as assessed by change in number of days abstinent

    Time frame: Baseline, 6 and 12 months

    Number of days abstinent.

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Hutton, PhD

CONTACT

[email protected]

14104586715

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Alcohol Research Consortium in HIV: Relapse Prevention Arm

Acronym: ARCH-RPA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2021
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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