Alcohol Research in HIV: Relapse Prevention (ARCH-RPA)
Primary Purpose
HIV, Alcohol Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relapse Prevention Intervention
Sponsored by
About this trial
This is an interventional treatment trial for HIV
Eligibility 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:
- 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
Sites / Locations
- Johns Hopkins School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Computer delivered RPI
Person delivered RPI
Treatment as Usual
Arm Description
2 session computer delivered counseling to prevent relapse to hazardous drinking
2 session counselor delivered counseling to prevent relapse to hazardous drinking
Counseling for alcohol use available in clinic as treatment as usual
Outcomes
Primary Outcome Measures
Change in time to relapse
Time to return to any alcohol use or any at risk alcohol use after intervention.
Secondary Outcome Measures
Alcohol use pattern as assessed by change in number of drinking days
Number of drinking days.
Alcohol use pattern as assessed by change in number of heavy drinking days
Number of heavy drinking days.
Alcohol use pattern as assessed by change in number of drinks per drinking day
Number of drinks per drinking day.
Alcohol use pattern as assessed by change in number of days abstinent
Number of days abstinent.
Full Information
NCT ID
NCT05163301
First Posted
December 6, 2021
Last Updated
July 7, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05163301
Brief Title
Alcohol Research in HIV: Relapse Prevention
Acronym
ARCH-RPA
Official Title
Alcohol Research Consortium in HIV: Relapse Prevention Arm
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computer delivered RPI
Arm Type
Experimental
Arm Description
2 session computer delivered counseling to prevent relapse to hazardous drinking
Arm Title
Person delivered RPI
Arm Type
Experimental
Arm Description
2 session counselor delivered counseling to prevent relapse to hazardous drinking
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Counseling for alcohol use available in clinic as treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention Intervention
Intervention Description
2 session intervention to address relapse prevention among people with HIV who have an alcohol use disorder
Primary Outcome Measure Information:
Title
Change in time to relapse
Description
Time to return to any alcohol use or any at risk alcohol use after intervention.
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Alcohol use pattern as assessed by change in number of drinking days
Description
Number of drinking days.
Time Frame
Baseline, 6 and 12 months
Title
Alcohol use pattern as assessed by change in number of heavy drinking days
Description
Number of heavy drinking days.
Time Frame
Baseline, 6 and 12 months
Title
Alcohol use pattern as assessed by change in number of drinks per drinking day
Description
Number of drinks per drinking day.
Time Frame
Baseline, 6 and 12 months
Title
Alcohol use pattern as assessed by change in number of days abstinent
Description
Number of days abstinent.
Time Frame
Baseline, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Hutton, PhD
Phone
14104586715
Email
hhutton@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Hutton, PhD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Hutton
First Name & Middle Initial & Last Name & Degree
Heidi Hutton, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
NIAAA has begun a new data-sharing initiative to create a data repository of future NIAAA-funded studies that include human subjects. This repository is called the NIAAA Data Archive (NIAAA DA). NIAAA-funded investigators conducting human subjects research are expected to submit de-identified, individual-level data to this data archive.
The NIAAA DA accepts only electronic, de-identified data from human subjects studies. Data submitted to the NIAAA DA must be de-identified by the investigator prior to submission.
IPD Sharing Time Frame
Data will be shared with the general research community 2 years after the grant end date on the initial Notice of Award. This 2-year embargo period will provide study investigators with protected time to publish from the study data. After the embargo, the data will be made available for sharing with the general research community via the NIAAA DA website. However, if a manuscript using study data is accepted for publication prior to the 2-year embargo, the study data specifically used in that manuscript will be shared with the general research community at the time of publication.
IPD Sharing Access Criteria
Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAA DA data by submitting a data access request in accordance with applicable NIAAA DA policies. Data requests will be reviewed and granted by a NIAAA Data Access Committee.
IPD Sharing URL
https://grants.nih.gov/grants/guide/notice-files/NOT-AA-19-020.html
Learn more about this trial
Alcohol Research in HIV: Relapse Prevention
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