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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Community Intervention | Experimental | Participants will participate in an online community with structured sessions as well as the ability to communicate freely with others. |
|
| Standard of Care | Active Comparator | Participants will be exposed to what's disseminated within their communities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Community Intervention | Behavioral | Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems |
|
| Measure | Description | Time Frame |
|---|---|---|
| Test HIV | Self-request of HIV test and confirmation of completion. Binary (Yes/No) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Test HCV | Self-request of HCV test and confirmation of completion. Binary (Yes/No) | 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.) | 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.) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Receive HIV Treatment | Self-report of HIV treatment reception. Binary (Yes/No) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Receive HCV Treatment | Self-report of HCV treatment reception. Binary (Yes/No) | 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) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Use PrEP | Self-report of PrEP use. Binary (Yes/No) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Six Yes/No Behaviors Promoted by Intervention | Measures: Sum of Yes to (a) self-testing for HIV, (b) self-testing for HCV, (c) HIV prevention, (d) requesting Naloxone, (e) carrying Naloxone, and (f) making at least one social connection (new or reestablished). Continuous (0 to 6) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dolores Albarracin, PhD | Univ. of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19103 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2025 | Mar 4, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Clusters will be randomized to either the intervention or the standard of care.
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The outcomes assessor will be unaware of the experimental condition.
| Standard of Care | Behavioral | health websites and county information provided to participants |
|
| 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), Immediate Follow-Up (3 Weeks), 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), 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) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Renewed Social Connections | Self-report of reconnecting with previously distant community members. Continuous (Numeric) | 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) | 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) | 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) | 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) | 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) | 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) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Test for M-pox | Self-report of M-pox testing received. Binary (Yes/No) | 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) | 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) | 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) | 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) | Baseline, Immediate Follow-Up (3 Weeks), 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), 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. | 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) | 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) | Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Made at Least One New/Re-established Social Connection | Self-report of at least one new social connection made or one old social connection re-established. Binary (Yes/No) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| Social Support and Connection | Self-report of perceptions of support from and connection to others. Scale (Never; Rarely; Sometimes; Often) | Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |