跳至主要内容
临床试验/NCT06702007
NCT06702007招募中3 期

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

University of Washington2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年1月20日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
160
试验地点
2
主要终点
Change in physical and mental-health related quality of life from baseline through 3-month follow-up as measured by the EQ-5D-5L

研究概览

简要总结

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.

详细描述

Brief Summary The goal of this two phased project is to adapt an in-person harm reduction intervention (HaRT-A) into a telehealth platform (eHaRT-A; Phase 1) and test it among individuals with lived experience of homelessness and alcohol use disorder (AUD) in a Housing First (HF) framework (Phase 2). The proposed study will utilize nuanced methodologies that combine community-based participatory research (CBPR) with user-centered technology design. eHaRT-A will be collaboratively adapted with input from HF stakeholders to maximize its acceptability, feasibility, and usability within the HF framework to optimize effectiveness of the eHaRT-A intervention.

Study Design People experiencing homelessness are disproportionately affected by alcohol-related morbidity and mortality with 7 times higher prevalence of AUD than the general population. Traditionally, people with AUD could not attain permanent supportive housing until they attended treatment and achieved abstinence. These requirements served as barriers to housing attainment, relegating people who were not ready, willing or able to stop drinking to continued homelessness. Alternatively, over the past thirty years nonabstinence-based supportive housing, known as Housing First (HF), has emerged as a more effective option by providing immediate, permanent, low-barrier housing to individuals regardless of their alcohol use. HF facilities provide supportive services through HF partners which includes outreach, case management, nursing/medical care, access to external service providers, assistance meeting basic needs [i.e., food, clothing, income, housing]. The HF framework has shown promising effects where those in HF utilized fewer public services (i.e. hospitalizations and emergency service use; jail, and public detoxification and sobering center visits), resulting in a nearly four-million-dollar savings to the city of Seattle (in one year) compared to individuals experiencing homelessness who did not access HF resources. Although these findings are promising, individuals living in HF facilities still report contraindicated levels of drinking and experience significant alcohol-related problems. In order to address this need, an in-person, patient-driven, harm-reduction treatment for alcohol (HaRT-A; R34AA022077; PI: Collins) intervention was codeveloped and empirically tested in a randomized controlled trial (RCT). HaRT-A uses a compassionate, non-judgmental, and advocacy-oriented approach. It does not require abstinence or use reduction and comprises 3 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 (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 (ref. 87,88) and acknowledges the larger forces (familial, community, geopolitical) at play in substance use (ref. 89,90), thus emphasizing the wisdom of the participant in defining their own pathway to recovery. The proposed K01 aims to adapt HaRT-A into a telehealth platform (eHaRT-A) to introduce technology-based alcohol-specific interventions into a HF framework and test it among individuals with lived experience of homelessness and AUD. This project will occur in two phases: Phase 1 will entail codevelopment and iterative testing of the telehealth platform with community stakeholders (i.e., Housing First residents, management, and staff) to leverage stakeholder ideas to inform and build the eHaRT-A prototype and to make design changes that will improve the usability and likeability of the virtual telehealth platform. The primary outcome for Phase 1 is to co-develop (with the CAB) a prototype for eHaRT-A that is deemed usable, feasible, and acceptable by all HF stakeholders (via System Usability Scale [SUS] and Acceptability of Intervention Measure [AIM]). Dr. Frohe will meet the CAB every other week to codesign eHaRT-A (i.e., ensure usable design; Aim 1) and make iterative design changes to improve the acceptability and feasibility of eHaRT-A (i.e., delivery; Aim 2). In Phase 2 an RCT will be conducted (N=160) to test the effectiveness of the eHaRT-A telehealth intervention compared to services as usual (SAU; supportive services provided through HF partners) in improving alcohol-related outcomes (i.e., peak alcohol use, alcohol-related harm, AUD symptoms, and positive urinary ethyl glucuronide tests) and HRQoL over time (Aim 3). The proposed research aligns with national (NIH; NOT-AA-20-011) health initiatives to integrate technology-based interventions for vulnerable and marginalized communities with pre-existing substance use treatments. If successful, this study will lead to the development of a clinically relevant intervention that is more easily transportable to marginalized community settings because it will be developed for, by, and with the community it aims to serve.

Narrative Study Description The proposed study aims will be to leverage stakeholder ideas to inform and build a usable eHaRT-A prototype (Aim 1) and to make iterative design changes that will improve the acceptability and feasibility of the virtual telehealth platform (Aim 2) in Phase 1. The primary outcome for Phase 1 is to co-develop (with the CAB) a prototype for eHaRT-A that is deemed usable, feasible, and acceptable by all HF stakeholders (via System Usability Scale [SUS] and Acceptability of Intervention Measure [AIM]). Self-report on the SUS (ref 101) will also be collected from the group to examine preliminary usability ratings (e.g., clear content portrayal, easy to follow) to evaluate the functionality of eHaRT-A with CAB members in order to enrich and enhance the delivery of eHaRT-A. Based on previous work, a mean score among CAB members of 5 out of a 7-point scale will be considered favorable for the prototype design. (ref. 14,16,98) Phase 2 will entail a randomized controlled trial (RCT) comparing eHaRT-A to services as usual (SAU; supportive services provided through HF partners). This RCT will be a two-armed effectiveness trial and will assess both conditions at baseline, posttest (immediately following treatment end), 1- and 3-month follow-ups. This RCT will test the effectiveness of the eHaRT-A telehealth intervention compared to services as usual (SAU; supportive services provided through HF partners) in improving alcohol-related outcomes (i.e., peak alcohol use, alcohol-related harm, AUD symptoms, and positive urinary ethyl glucuronide tests) and HRQoL over time (Aim 3).

Participants and Recruitment:

Eligible participants will be adults who (1) are registered clients at one of the HF sites, (2) being at least 21 years of age, and (3) fulfilling criteria for a current alcohol use disorder (AUD; based on DSM-V semi-structured interview).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Change in physical and mental-health related quality of life from baseline through 3-month follow-up as measured by the EQ-5D-5L

时间窗: Baseline through 3-month follow-up

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.

Change in typical and peak alcohol quantity consumed from baseline through 3-month follow-up as assessed by the AQUA.

时间窗: Baseline through 3-month follow-up

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.

Change in alcohol-related harm from baseline through 3-month follow-up as assessed by the SIP-2R.

时间窗: Baseline to 3-month follow-up

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.

Feasibility of eHaRT-A within Housing First

时间窗: Baseline to 3-month follow-up.

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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tessa Frohe

Assistant Professor, Department of Psychiatry & Behavioral Sciences

University of Washington

研究点 (2)

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