Electronic Harm Reduction Treatment for Alcohol
eHaRT-A
eHaRT-A: Adapting an Evidence-based, In-person Harm Reduction Treatment Into a Virtual Care Telehealth Intervention for People With Lived Experience of Homelessness and Alcohol Use Disorder
2 other identifiers
interventional
160
1 country
1
Brief Summary
The goal of this project is to transform a successful, face-to-face harm-reduction treatment (HaRT-A) into a digital format, creating eHaRT-A. This new platform is specifically designed for people who have experienced homelessness and an alcohol use disorder (AUD), living within the framework of permanent, supportive, Housing First (HF) facilities. We hypothesize eHaRT-A will be more effective than the standard HF services in reducing alcohol-related harm and improving the overall quality of life for participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2025
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedStudy Start
First participant enrolled
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
July 8, 2025
July 1, 2025
1.9 years
November 19, 2024
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in physical and mental-health related quality of life from baseline through 3-month follow-up as measured by the EQ-5D-5L
The EQ-5D-5L is a psychometrically sound, 5-item, 5-point Likert scale measure that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Its summary score will reflect participants' health-related quality of life (HRQoL) as a primary outcome.
Baseline through 3-month follow-up
Change in typical and peak alcohol quantity consumed from baseline through 3-month follow-up as assessed by the AQUA.
The Alcohol Quantity and Use Assessment (AQUA) was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest and typical drinking days in the past two weeks. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.
Baseline through 3-month follow-up
Change in alcohol-related harm from baseline through 3-month follow-up as assessed by the SIP-2R.
The Short Inventory of Problems (SIP-2R) is a 15-item, Likert-scale questionnaire that measures social, occupational and psychological alcohol-related problems. The summary score will serve as the alcohol-related problems outcome measure.
Baseline to 3-month follow-up
Feasibility of eHaRT-A within Housing First
Feasibility will be assessed as ease of enrollment of participants into the study as well as ability to retain participants during the intervention portion of the study (i.e., percentage screened who expressed interest, qualified, and completed eHaRT-A).
Baseline to 3-month follow-up.
Secondary Outcomes (3)
Change in motivation/readiness/importance/confidence to engage in harm reduction from baseline through 3-month follow-up as assessed by the MTC.
Baseline through 3-month follow-up
Change in alcohol frequency from baseline through 3-month follow-up as assessed by the ASI.
Baseline through 3-month follow-up
Change in biochemical verification of EtG from baseline to 3-month follow-up.
Baseline to 3-month follow-up
Other Outcomes (5)
Change in eHaRT receipt/enactment outcomes from baseline to 1-month follow-up as assessed by the SHaRE form.
Baseline through 1-month follow-up.
Change in pain from baseline through 3-month as assessed by the BPI.
Baseline through 3-month follow-up
eHaRT-A participant feedback at follow-up.
1- or 3- month follow-up.
- +2 more other outcomes
Study Arms (2)
Housing First As Usual
NO INTERVENTIONHousing First as usual includes housing provision and management, fulfillment of basic needs (e.g., food, clothing), nursing/medical services and case management.
Housing First + eHaRT-A
EXPERIMENTALHaRT-A comprises three concrete treatment components: 1) measurement and participant-led tracking of indicators of alcohol-related harm (e.g., number of drinks, blackouts), 2) elicitation of harm-reduction and health related quality of life (HRQoL) goals (e.g., drink slower, eat healthier, reconnect with family), and 3) discussion of safer-drinking strategies (e.g., taking B-complex vitamins, eating prior to or during alcohol use, avoiding mixing alcohol and other drugs). HaRT-A honors community representation within harm-reduction intervention development and acknowledges the larger forces (familial, community, geopolitical) at play in substance use, thus emphasizing the wisdom of the participant in defining their own pathway to recovery.
Interventions
Adaptation of the Harm Reduction Treatment for Alcohol (HaRT-A) into a digital telehealth platform facilitating harm reduction treatment via patient-provider video sessions (eHaRT-A). eHaRT-A will include the three treatment components from the efficacious HaRT-A. eHaRT-A will be delivered during one-on-one sessions through video conferencing with interactive features (i.e., personalized feedback tracked over time and screen sharing).
Eligibility Criteria
You may qualify if:
- Being at least 21 years of age
- Speak English fluently
- Currently a registered client at one of the Housing First sites
- Currently drinking (has used alcohol in the past 2 weeks)
- Meeting criteria for "current" (e.g., past-year) AUD according to the Diagnostic and Statistical Manual of Mental Health Disorders, Fifth Edition (determined as scoring \>= 2 on the SCID-5-CV)
You may not qualify if:
- Enrollment in any related treatment studies (including studies by this research team)
- Refusal or inability to consent
- Constituting a risk to the safety and security of residents or staff
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Downtown Emergency Service Center
Seattle, Washington, 98104, United States
Related Publications (4)
Collins SE, Duncan MH, Saxon AJ, Taylor EM, Mayberry N, Merrill JO, Hoffmann GE, Clifasefi SL, Ries RK. Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial. Lancet Psychiatry. 2021 Apr;8(4):287-300. doi: 10.1016/S2215-0366(20)30489-2. Epub 2021 Mar 10.
PMID: 33713622BACKGROUNDCollins SE, Malone DK, Clifasefi SL, Ginzler JA, Garner MD, Burlingham B, Lonczak HS, Dana EA, Kirouac M, Tanzer K, Hobson WG, Marlatt GA, Larimer ME. Project-based Housing First for chronically homeless individuals with alcohol problems: within-subjects analyses of 2-year alcohol trajectories. Am J Public Health. 2012 Mar;102(3):511-9. doi: 10.2105/AJPH.2011.300403. Epub 2012 Jan 19.
PMID: 22390516BACKGROUNDCollins SE, Clifasefi SL, Nelson LA, Stanton J, Goldstein SC, Taylor EM, Hoffmann G, King VL, Hatsukami AS, Cunningham ZL, Taylor E, Mayberry N, Malone DK, Jackson TR. Randomized controlled trial of harm reduction treatment for alcohol (HaRT-A) for people experiencing homelessness and alcohol use disorder. Int J Drug Policy. 2019 May;67:24-33. doi: 10.1016/j.drugpo.2019.01.002. Epub 2019 Mar 6.
PMID: 30851620BACKGROUNDTsemberis S, Gulcur L, Nakae M. Housing First, consumer choice, and harm reduction for homeless individuals with a dual diagnosis. Am J Public Health. 2004 Apr;94(4):651-6. doi: 10.2105/ajph.94.4.651.
PMID: 15054020BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tessa Frohe, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Psychiatry & Behavioral Sciences
Study Record Dates
First Submitted
November 19, 2024
First Posted
November 22, 2024
Study Start
January 20, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
July 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
The proposed research involves participants from Housing First programs serving highly vulnerable populations, including those experiencing chronic homelessness and substance use disorders. Historical misuse of data on stigmatized behaviors has caused significant harm, including stigma and misrepresentation in politicized media narratives. Sharing individual participant data (IPD) risks breaching anonymity in tight-knit communities and undermining ethical commitments to community-based participatory research (CBPR), which prioritizes data use for the community's benefit. Given these risks, we do not plan to share IPD beyond the specific aims of this study.