Hepatitis C Virus Infection, HIV Infections
Conditions
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.
Interventions
BEHAVIORALVirtual Community Intervention
Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems
BEHAVIORALStandard of Care
health websites and county information provided to participants
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be unaware of the experimental condition.
Intervention model description
Clusters will be randomized to either the intervention or the standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test HIV | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-request of HIV test and confirmation of completion. Binary (Yes/No) |
| Test HCV | 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 | 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 | 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 | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of HIV treatment reception. Binary (Yes/No) |
| Receive HCV Treatment | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of HCV treatment reception. Binary (Yes/No) |
| Receive Over-the-Counter Narcan | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Use PrEP | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of PrEP use. Binary (Yes/No) |
| 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 | Self-report of condom use during sex. Scale (Never; Sometimes; Almost always; Always) |
| 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 | Self-report of supporting others as they attend to a health issue. Binary (Yes/No) |
| 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 | Self-report of providing support for someone with SUD. Binary (Yes/No) |
| 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 | Self-report of providing support for someone with a past SUD. Binary (Yes/No) |
| 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 | Self-report of providing support for the relative of someone with SUD. Binary (Yes/No) |
| 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 | Self-report of hurtful or stigmatizing language towards people with SUD. Scale (Never; Sometimes; Almost always; Always) |
| 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 | Self-report of hurtful or stigmatizing language towards people of other groups. Scale (Never; Sometimes; Almost always; Always) |
| 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 | Self-report of behavioral intentions to prevent or intervene in hurtful or stigmatizing language. Scale (Never; Sometimes; Almost always; Always) |
| 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 | Self-report of seeking professional help with mental health concerns. Binary (Yes/No) |
| 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 | Self-report of 12-step group attendance for people who use drugs or are in recovery. Binary (Yes/No) |
| 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 | 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) |
| 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 | Self-report of medication-assisted recovery program attendance for people who use drugs or are in recovery. Binary (Yes/No) |
| 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 | Self-report of religious-based substance use group attendance. Binary (Yes/No) |
| Receive COVID-19 vaccine(s) as currently required (measure past and last shot) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of received COVID-19 vaccine shots, with most recent shot date and number of shots. Binary (Yes/No) Date (YMD) |
| Take a flu shot during the most recent season | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of received influenza vaccine shots, with most recent shot date. Binary (Yes/No) |
| Carry Naloxone | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of frequency that an individual has Naloxone on their person. Binary (Yes/No) |
| Use Naloxone on someone | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of instances where Naloxone was used by the individual to address an overdose or suspected overdose. Binary (Yes/No) |
| Has someone administered Naloxone on you? | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of another using Naloxone on the individual. Binary (Yes/No) |
| Test for COVID-19 | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of COVID-19 testing. Binary (Yes/No) Continuous (Numerical) |
| Test for M-pox | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of M-pox testing received. Binary (Yes/No) |
| 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 | 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) |
| Use substance without a prescription or more than prescribed | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | 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) |
| Injection drug use | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | 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) |
| Use someone else's syringe | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Self-report of sharing needles with another person. Continuous (Numerical) |
| 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 | Completion of requested Narcan Training. Binary (Yes/No) |
| Requesting safe-injection supplies | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months | Request for wound-care kits for injection sites and/or syringe cleaning kits. |
| 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 | Self-report of support for MAT. Scale: (Not at all; A little; Somewhat; A lot; A great deal) |
| 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 | Self-report of support for therapeutic programs to reduce drug addiction. Scale: (Not at all; A little; Somewhat; A lot; A great deal) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDolores Albarracin, PhD
Univ. of Pennsylvania
Outcome results
None listed