Digital Community to Improve Health in Rural Areas

Study Overview
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Brief Summary
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The study is a cluster randomized controlled trial developed in counties located in Appalachia and the Midwest. Counties are selected to have high risk for HIV and HCV infection associated with injection drug use.

Detailed Description
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The study will randomize clusters with groups of participants to an intervention or a standard of care condition.

Official Title
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Digital, Community-Led, Social Action Initiative to Reduce Opioid Vulnerability and HIV/HCV in Rural Areas of the Midwest and Appalachia

Conditions
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HIV Infections, Hepatitis C Virus Infection

Intervention / Treatment
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* Behavioral: Virtual Community Intervention
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lives in target zip codes Half not using illicit substances in the last year Half using illicit substances in the last month Exclusion Criteria: Under the age of 18 Not in target zip codes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Clusters will be randomized to either the intervention or the standard of care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Community Intervention<br>Participants will participate in a community with structured sessions as well as the ability to communicate freely with others. | Behavioral: Virtual Community Intervention<br>* Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems<br>|
| Active Comparator: Standard of Care<br>Participants will be exposed to what's disseminated within their communities | Behavioral: Standard of Care<br>* health websites and county information provided to participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test HIV | Self-request of HIV test and confirmation of completion. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Test HCV | Self-request of HCV test and confirmation of completion. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Know HIV Status | Self-report of HIV status understanding. Binary (I tested positive for HIV; I tested negative for HIV.) | Baseline, 3 months, 6 months | 
| Know HCV Status | Self-report of HCV status understanding. Binary (I tested positive for HCV; I tested negative for HCV.) | Baseline, 3 months, 6 months | 
| Receive HIV Treatment | Self-report of HIV treatment reception. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Receive HCV Treatment | Self-report of HCV treatment reception. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Receive Over-the-Counter Narcan | Request to receive over-the-counter Narcan, depending on the ability to distribute Narcan in the state of residence. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Use syringe services (e.g., exchange) | Self-report of using a syringe service program. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Disinfect injection equipment | Self-report of injection tool cleaning prior to use. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| New Social Connections | Self-report of new social connections made with others in the community. Continuous (Numeric) | Baseline, 3 months, 6 months | 
| Renewed Social Connections | Self-report of reconnecting with previously distant community members. Continuous (Numeric) | Baseline, 3 months, 6 months | 
| Contributions to town, neighborhoods, and community | Self-report of community engagement and betterment through acts of service or kindness. Scale (Not at all; A little; Somewhat; A lot; A great deal) | Baseline, 3 months, 6 months | 
| Discovering services or groups | Self-report of newly discovered social services or groups in their communities. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Joining groups, organizations, or activities | Self-report of newly joined groups, organizations, or activities in the community. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Encouraging others to test for HIV/HCV | Self-report of instances where individuals suggest or encourage HIV/HCV testing. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Encouraging others to treat substance use disorder or HIV/HCV | Self-report of instances where individuals suggest or encourage others to be treated for substance use disorder, HIV, or HCV. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Discuss substance use issues with others | Self-report of instances where individual discusses substance use issues with other members of their community. Binary (Yes/No) | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use PrEP | Self-report of PrEP use. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Use a condom during sex | Self-report of condom use during sex. Scale (Never; Sometimes; Almost always; Always) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Support for another with a health issue | Self-report of supporting others as they attend to a health issue. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Support somebody who is presently struggling with substance use disorder | Self-report of providing support for someone with SUD. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Support somebody who has had struggles with substance use disorder | Self-report of providing support for someone with a past SUD. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Support somebody who has a family member who has a substance use disorder | Self-report of providing support for the relative of someone with SUD. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Refrain from using hurtful language to refer to people with substance use disorder | Self-report of hurtful or stigmatizing language towards people with SUD. Scale (Never; Sometimes; Almost always; Always) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Refrain from using hurtful language to refer to people from other groups (e.g., religious) | Self-report of hurtful or stigmatizing language towards people of other groups. Scale (Never; Sometimes; Almost always; Always) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Intention to intervene when someone uses hurtful language | Self-report of behavioral intentions to prevent or intervene in hurtful or stigmatizing language. Scale (Never; Sometimes; Almost always; Always) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| See a mental health professional if there are mental health concerns including substance use | Self-report of seeking professional help with mental health concerns. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Attend a 12-step group (if using substances or in recovery) | Self-report of 12-step group attendance for people who use drugs or are in recovery. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Attend another abstinence-based program (if using substances or in recovery) | Self-report of abstinence-based program attendance for people who use drugs or are in recovery (not 12-step group or religious-based). Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Attend a substance use treatment program that uses medications (if using substances or in recovery) | Self-report of medication-assisted recovery program attendance for people who use drugs or are in recovery. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Attend a religious-based substance use group (if using substances or in recovery) | Self-report of religious-based substance use group attendance. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Receive COVID-19 vaccine(s) as currently required (measure past and last shot) | Self-report of received COVID-19 vaccine shots, with most recent shot date and number of shots. Binary (Yes/No) Date (YMD) | Baseline, 3 months, 6 months | 
| Take a flu shot during the most recent season | Self-report of received influenza vaccine shots, with most recent shot date. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Carry Naloxone | Self-report of frequency that an individual has Naloxone on their person. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Use Naloxone on someone | Self-report of instances where Naloxone was used by the individual to address an overdose or suspected overdose. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Has someone administered Naloxone on you? | Self-report of another using Naloxone on the individual. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Test for COVID-19 | Self-report of COVID-19 testing. Binary (Yes/No) Continuous (Numerical) | Baseline, 3 months, 6 months | 
| Test for M-pox | Self-report of M-pox testing received. Binary (Yes/No) | Baseline, 3 months, 6 months | 
| Drink alcohol frequency | Self-report of frequency of alcohol consumption, number of drinks, and drunkenness. Scale (Never; A few times but not in the past year Once a month; A few times a month Once a week; A few times a week Once a day; More than once a day) Scale (Never; A few times but not in the past year Once a month; A few times a month Once a week; A few times a week Once a day; More than once a day) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Use substance without a prescription or more than prescribed | Self-report of substance use, not including proper use of prescription drugs. Scale (Never; Tried it one or more times; Once a month or less often; 2-4 times a month; 2-3 times a week; 4 times a week or more) | Baseline, 3 months, 6 months | 
| Injection drug use | Self-report of injection drug use, not including proper use of prescription drugs. Binary (Yes/No) Scale (Not at all; A few times; A few times a week; Everyday) | Baseline, 3 months, 6 months | 
| Use someone else's syringe | Self-report of sharing needles with another person. Continuous (Numerical) | Baseline, 3 months, 6 months | 
| Complete Narcan training | Completion of requested Narcan Training. Binary (Yes/No) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Requesting safe-injection supplies | Request for wound-care kits for injection sites and/or syringe cleaning kits. | Baseline, 3 months, 6 months | 
| Support for medication assisted treatment (MAT) | Self-report of support for MAT. Scale: (Not at all; A little; Somewhat; A lot; A great deal) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months | 
| Support for therapeutic programs to reduce drug addiction | Self-report of support for therapeutic programs to reduce drug addiction. Scale: (Not at all; A little; Somewhat; A lot; A great deal) | Baseline, Session 2 ( 2 weeks, Experimental Group Only), Session 3 ( 3 weeks, Experimental Group Only), 3 months, 6 months |