Electronic Harm Reduction Treatment for Alcohol

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).

Exclusion criterion are (1) refusal or inability to consent to participation in research; (2) constituting a risk to safety and security of other clients or staff; and (3) enrollment in any related treatment studies (incl. studies by this research team). Ability to consent will be assessed during the information session using the UCSD Brief Assessment of Capacity to Consent (UBACC). This 10-item, 3-point Likert-scale measure ensures participants understand the study protocol, potential risks/benefits and their rights as participants prior to study enrollment.

Participants will be recruited from study flyers that will be posted throughout HF facilities to recruit HF residents. Additionally, HF staff, research staff and CAB members will notify HF residents of the opportunity to participate in the study and/or distribute flyers to individuals. Soon thereafter, research staff will be onsite at various HF facilities in rotation to conduct informational sessions (lasting \~20 minutes) and baseline assessments with interested HF residents. During informational sessions, research staff will explain the study procedures, study participants' rights and informed consent materials. If they agree to participate, written informed consent will be obtained, and participants may elect to complete the baseline assessment or schedule it for a later date (within two weeks).

Assessments:

Phase 1: CAB members will complete self-report on the SUS101 during Step 3 of Phase 1 to examine preliminary usability ratings (e.g., clear content portrayal, easy to follow) and to evaluate the functionality of eHaRT-A with CAB members in order to enrich and enhance the delivery of eHaRT-A for HF residents interested in the intervention. Next, Step 4 of Phase 1 will entail an open trial where HF residents will be invited to participate in a single eHaRT-A session. They will complete self-report questionnaires on acceptability (i.e., the AIM,102 SUS,101), alcohol use, and health related quality of life.

Phase 2: Participants will complete EtG urine sample tests and self-report questionnaires on alcohol use and quality of life at baseline, week 2, week 3 and at their 1- and 3-month follow-up appointments. Semi-structured interviews will be also be recorded at the 1-month follow up to examine open ended responses about participant levels of eHaRT-A comprehension, efficacy, and suggestions for its improvement (via Participant Feedback). (ref. 101,102) Finally, qualitative data analysis of participant satisfaction and suggestions for improvement will be conducted using conventional content analysis,(ref. 121) a methodology that facilitates description of qualitative data through a systematic process of coding and classification, will be used to delineate common responses to predetermined categories: subjective reactions to the eHaRT-A; intent to use eHaRT-A principles in the future; and suggestions for improvement which can be disseminated through manuscript publications.

• Change in motivation/readiness/importance/confidence to engage in harm reduction from baseline through 3-month follow-up as assessed by the MTC. [Срок оценки: Baseline through 3-month follow-up]
• Change in alcohol frequency from baseline through 3-month follow-up as assessed by the ASI. [Срок оценки: Baseline through 3-month follow-up]
• Change in biochemical verification of EtG from baseline to 3-month follow-up. [Срок оценки: Baseline to 3-month follow-up]