Digital, Community-Led, Social Action Initiative to Reduce Opioid Vulnerability and HIV/HCV in Rural Areas of the Midwest and Appalachia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 511
- Locations
- 2
- Primary Endpoint
- Test HIV
Study Overview
Brief Summary
The study is a cluster randomized controlled trial developed in counties located in Appalachia and the Midwest. We will prioritize counties from states with high risk for HIV and HCV infection associated with injection drug use.
Detailed Description
The study will randomize clusters with groups of participants to an intervention or a standard of care condition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor will be unaware of the experimental condition.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Lives in target zip codes
- •Half not using illicit substances (not including marijuana) currently or in the past
- •Half using illicit substances (not including marijuana) currently or in the past
Exclusion Criteria
- •Under the age of 18
- •Not in target zip codes
Arms & Interventions
Virtual Community Intervention
Participants will participate in an online community with structured sessions as well as the ability to communicate freely with others.
Intervention: Virtual Community Intervention (Behavioral)
Standard of Care
Participants will be exposed to what's disseminated within their communities
Intervention: Standard of Care (Behavioral)
Outcomes
Primary Outcomes
Test HIV
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-request of HIV test and confirmation of completion. Binary (Yes/No)
Test HCV
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-request of HCV test and confirmation of completion. Binary (Yes/No)
Know HIV Status
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of HIV status understanding. Binary (I tested positive for HIV; I tested negative for HIV.)
Know HCV Status
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of HCV status understanding. Binary (I tested positive for HCV; I tested negative for HCV.)
Receive HIV Treatment
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of HIV treatment reception. Binary (Yes/No)
Receive HCV Treatment
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of HCV treatment reception. Binary (Yes/No)
Receive Over-the-Counter Narcan
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Request to receive over-the-counter Narcan, depending on the ability to distribute Narcan in the state of residence. Binary (Yes/No)
Use syringe services (e.g., exchange)
Time Frame: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of using a syringe service program. Binary (Yes/No)
Disinfect injection equipment
Time Frame: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of injection tool cleaning prior to use. Binary (Yes/No)
New Social Connections
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of new social connections made with others in the community. Continuous (Numeric)
Renewed Social Connections
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of reconnecting with previously distant community members. Continuous (Numeric)
Contributions to town, neighborhoods, and community
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
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)
Discovering services or groups
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of newly discovered social services or groups in their communities. Binary (Yes/No)
Joining groups, organizations, or activities
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of newly joined groups, organizations, or activities in the community. Binary (Yes/No)
Encouraging others to test for HIV/HCV
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of instances where individuals suggest or encourage HIV/HCV testing. Binary (Yes/No)
Encouraging others to treat substance use disorder or HIV/HCV
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of instances where individuals suggest or encourage others to be treated for substance use disorder, HIV, or HCV. Binary (Yes/No)
Discuss substance use issues with others
Time Frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Self-report of instances where individual discusses substance use issues with other members of their community. Binary (Yes/No)
Secondary Outcomes
- Use PrEP(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Use a condom during sex(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Support for another with a health issue(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Support somebody who is presently struggling with substance use disorder(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Support somebody who has had struggles with substance use disorder(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Support somebody who has a family member who has a substance use disorder(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Refrain from using hurtful language to refer to people with substance use disorder(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Refrain from using hurtful language to refer to people from other groups (e.g., religious)(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Intention to intervene when someone uses hurtful language(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- See a mental health professional if there are mental health concerns including substance use(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Attend a 12-step group (if using substances or in recovery)(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Attend another abstinence-based program (if using substances or in recovery)(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Attend a substance use treatment program that uses medications (if using substances or in recovery)(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Attend a religious-based substance use group (if using substances or in recovery)(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Receive COVID-19 vaccine(s) as currently required (measure past and last shot)(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Take a flu shot during the most recent season(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Carry Naloxone(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Use Naloxone on someone(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Has someone administered Naloxone on you?(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Test for COVID-19(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Test for M-pox(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Drink alcohol frequency(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Use substance without a prescription or more than prescribed(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Injection drug use(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Use someone else's syringe(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Complete Narcan training(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Requesting safe-injection supplies(Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Support for medication assisted treatment (MAT)(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)
- Support for therapeutic programs to reduce drug addiction(Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months)