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OpenTrials
Completed

NCT Number: NCT05363865

Digital Community to Improve Health in Rural Areas

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases Hepatitis Hepatitis C Hepatitis C Virus Infection Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Community Intervention

Behavioral

Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems

Standard of Care

Behavioral

health websites and county information provided to participants

Primary outcomes

  1. 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)

  2. 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)

  3. 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.)

  4. 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.)

  5. Receive HIV Treatment

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of HIV treatment reception.

    Binary (Yes/No)

  6. Receive HCV Treatment

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of HCV treatment reception.

    Binary (Yes/No)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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

  1. Use PrEP

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of PrEP use.

    Binary (Yes/No)

  2. Use a condom during sex

    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 condom use during sex.

    Scale (Never; Sometimes; Almost always; Always)

  3. Support for another with a health issue

    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 supporting others as they attend to a health issue.

    Binary (Yes/No)

  4. Support somebody who is presently struggling with substance use disorder

    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 providing support for someone with SUD.

    Binary (Yes/No)

  5. Support somebody who has had struggles with substance use disorder

    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 providing support for someone with a past SUD.

    Binary (Yes/No)

  6. Support somebody who has a family member who has a substance use disorder

    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 providing support for the relative of someone with SUD.

    Binary (Yes/No)

  7. Refrain from using hurtful language to refer to people with substance use disorder

    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 hurtful or stigmatizing language towards people with SUD.

    Scale (Never; Sometimes; Almost always; Always)

  8. Refrain from using hurtful language to refer to people from other groups (e.g., religious)

    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 hurtful or stigmatizing language towards people of other groups.

    Scale (Never; Sometimes; Almost always; Always)

  9. Intention to intervene when someone uses hurtful language

    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 behavioral intentions to prevent or intervene in hurtful or stigmatizing language.

    Scale (Never; Sometimes; Almost always; Always)

  10. See a mental health professional if there are mental health concerns including substance use

    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 seeking professional help with mental health concerns.

    Binary (Yes/No)

  11. Attend a 12-step group (if using substances or in recovery)

    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 12-step group attendance for people who use drugs or are in recovery.

    Binary (Yes/No)

  12. Attend another abstinence-based program (if using substances or in recovery)

    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 abstinence-based program attendance for people who use drugs or are in recovery (not 12-step group or religious-based).

    Binary (Yes/No)

  13. Attend a substance use treatment program that uses medications (if using substances or in recovery)

    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 medication-assisted recovery program attendance for people who use drugs or are in recovery.

    Binary (Yes/No)

  14. Attend a religious-based substance use group (if using substances or in recovery)

    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 religious-based substance use group attendance.

    Binary (Yes/No)

  15. Receive COVID-19 vaccine(s) as currently required (measure past and last shot)

    Time frame: 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)

  16. Take a flu shot during the most recent season

    Time frame: 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)

  17. Carry Naloxone

    Time frame: 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)

  18. Use Naloxone on someone

    Time frame: 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)

  19. Has someone administered Naloxone on you?

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of another using Naloxone on the individual.

    Binary (Yes/No)

  20. Test for COVID-19

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of COVID-19 testing.

    Binary (Yes/No) Continuous (Numerical)

  21. Test for M-pox

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of M-pox testing received.

    Binary (Yes/No)

  22. Drink alcohol frequency

    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 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)

  23. Use substance without a prescription or more than prescribed

    Time frame: 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)

  24. Injection drug use

    Time frame: 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)

  25. Use someone else's syringe

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of sharing needles with another person.

    Continuous (Numerical)

  26. Complete Narcan training

    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

    Completion of requested Narcan Training.

    Binary (Yes/No)

  27. Requesting safe-injection supplies

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Request for wound-care kits for injection sites and/or syringe cleaning kits.

  28. Support for medication assisted treatment (MAT)

    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 support for MAT.

    Scale: (Not at all; A little; Somewhat; A lot; A great deal)

  29. Support for therapeutic programs to reduce drug addiction

    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 support for therapeutic programs to reduce drug addiction.

    Scale: (Not at all; A little; Somewhat; A lot; A great deal)

Other outcomes

  1. Composite of Six Yes/No Behaviors Promoted by Intervention

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    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)

  2. Made at Least One New/Re-established Social Connection

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of at least one new social connection made or one old social connection re-established.

    Binary (Yes/No)

  3. Social Support and Connection

    Time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months

    Self-report of perceptions of support from and connection to others. Scale (Never; Rarely; Sometimes; Often)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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