protocolSection identificationModule nctId: NCT06281548, orgStudyIdInfo id: 23-2937, secondaryIdInfos id: 1F31DA058452, type: NIH, link: https://reporter.nih.gov/quickSearch/1F31DA058452, briefTitle: Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement., conditionsModule conditions: Stigma, Social, conditions: Substance Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: RESTART, outcomesModule primaryOutcomes measure: Change in Stigma Resistance Scale (SRS) Score, primaryOutcomes measure: Change in Substance Abuse Self-Stigma Scale (SASSS) Score, primaryOutcomes measure: Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment), primaryOutcomes measure: Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment), primaryOutcomes measure: Time to Sample Saturation (Feasibility - Recruitment), primaryOutcomes measure: Percentage of Participants Retained in Study (Feasibility - Retention), primaryOutcomes measure: Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User), primaryOutcomes measure: Percentage of Participants with High Text Message Frequency (Feasibility - User), primaryOutcomes measure: Percentage of Participants with High Text Messaging Comfort (Feasibility - User), primaryOutcomes measure: Percentage of Participants with Cell Phone Device Challenges (Feasibility - User), primaryOutcomes measure: Percentage of Participants with Cell Phone Plan Challenges (Feasibility - User), primaryOutcomes measure: Percentage of Participants who Read Messages Daily (Feasibility - User), secondaryOutcomes measure: Change in Adult Dispositional Hope Scale Score, secondaryOutcomes measure: Change in Rosenberg Self-Esteem Scale Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SHRPS Syringe Service Program, status: RECRUITING, city: Portsmouth, state: Ohio, zip: 45662, country: United States, contacts name: Adams L Sibley, MPH, role: CONTACT, phone: 423-227-9198, email: asibley@live.unc.edu, contacts name: Abby Spears, role: CONTACT, phone: 740-357-9773, email: abby@sciotoconnect.org, geoPoint lat: 38.73174, lon: -82.99767, hasResults: False