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.
The study will randomize clusters with groups of participants to an intervention or a standard of care condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
511
Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems
health websites and county information provided to participants
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Test HIV
Self-request of HIV test and confirmation of completion. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Test HCV
Self-request of HCV test and confirmation of completion. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Know HIV Status
Self-report of HIV status understanding. Binary (I tested positive for HIV; I tested negative for HIV.)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Know HCV Status
Self-report of HCV status understanding. Binary (I tested positive for HCV; I tested negative for HCV.)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Receive HIV Treatment
Self-report of HIV treatment reception. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Receive HCV Treatment
Self-report of HCV treatment reception. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Use syringe services (e.g., exchange)
Self-report of using a syringe service program. Binary (Yes/No)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Disinfect injection equipment
Self-report of injection tool cleaning prior to use. Binary (Yes/No)
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
New Social Connections
Self-report of new social connections made with others in the community. Continuous (Numeric)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Renewed Social Connections
Self-report of reconnecting with previously distant community members. Continuous (Numeric)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Discovering services or groups
Self-report of newly discovered social services or groups in their communities. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Joining groups, organizations, or activities
Self-report of newly joined groups, organizations, or activities in the community. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Use PrEP
Self-report of PrEP use. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Use a condom during sex
Self-report of condom use during sex. Scale (Never; Sometimes; Almost always; Always)
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
Support for another with a health issue
Self-report of supporting others as they attend to a health issue. Binary (Yes/No)
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
Support somebody who is presently struggling with substance use disorder
Self-report of providing support for someone with SUD. Binary (Yes/No)
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
Support somebody who has had struggles with substance use disorder
Self-report of providing support for someone with a past SUD. Binary (Yes/No)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Carry Naloxone
Self-report of frequency that an individual has Naloxone on their person. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Has someone administered Naloxone on you?
Self-report of another using Naloxone on the individual. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Test for COVID-19
Self-report of COVID-19 testing. Binary (Yes/No) Continuous (Numerical)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Test for M-pox
Self-report of M-pox testing received. Binary (Yes/No)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
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
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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Use someone else's syringe
Self-report of sharing needles with another person. Continuous (Numerical)
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months
Complete Narcan training
Completion of requested Narcan Training. Binary (Yes/No)
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
Requesting safe-injection supplies
Request for wound-care kits for injection sites and/or syringe cleaning kits.
Time frame: Baseline, Immediate Follow-Up (3 Weeks), 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)
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
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)
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