Clinical trial NCT06702007: Electronic Harm Reduction Treatment for Alcohol
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alcohol Use Disorder
Harm Reduction
Housing First (eg. Permanent Supportive Housing)
Keywords: Telehealth
Alcohol-Related Harm
Community Based Participatory Research
Lived experience of chronic homelessness
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-11-22
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in physical and mental-health related quality of life from baseline through 3-month follow-up as measured by the EQ-5D-5L
timeFrame: Baseline through 3-month follow-up
measure: Change in typical and peak alcohol quantity consumed from baseline through 3-month follow-up as assessed by the AQUA.
timeFrame: Baseline through 3-month follow-up
measure: Change in alcohol-related harm from baseline through 3-month follow-up as assessed by the SIP-2R.
timeFrame: Baseline to 3-month follow-up
measure: Feasibility of eHaRT-A within Housing First
timeFrame: Baseline to 3-month follow-up.
Secondary outcomes:
measure: Change in motivation/readiness/importance/confidence to engage in harm reduction from baseline through 3-month follow-up as assessed by the MTC.
timeFrame: Baseline through 3-month follow-up
measure: Change in alcohol frequency from baseline through 3-month follow-up as assessed by the ASI.
timeFrame: Baseline through 3-month follow-up
measure: Change in biochemical verification of EtG from baseline to 3-month follow-up.
timeFrame: Baseline to 3-month follow-up
Other outcomes:
measure: Change in eHaRT receipt/enactment outcomes from baseline to 1-month follow-up as assessed by the SHaRE form.
timeFrame: Baseline through 1-month follow-up.
measure: Change in pain from baseline through 3-month as assessed by the BPI.
timeFrame: Baseline through 3-month follow-up
measure: eHaRT-A participant feedback at follow-up.
timeFrame: 1- or 3- month follow-up.
measure: Change in acceptability, effectiveness, and likelihood to engage in eHaRT-A activities as assessed by Acceptability Rulers.
timeFrame: Baseline through 3-month follow-up
measure: Acceptability of the eHaRT-A intervention as assessed by the AIM at posttest.
timeFrame: Week 2
Locations:
city: Seattle
country: United States
facility: Downtown Emergency Service Center
state: Washington
Study officials:
affiliation: University of Washington
name: Tessa Frohe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Collins 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.
citation: Collins 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.
citation: Tsemberis 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.