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HIV InfectionsNCT05363865

Digital Community to Improve Health in Rural Areas

A study testing Virtual Community Intervention in people with HIV Infections and Hepatitis C Virus Infection, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, Hepatitis C Virus Infection
What is being tested?
Virtual Community Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
1 siteUnited States
Study dates
12 Jun 2023to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Under the age of 18
  • Not in target zip codes

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

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

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.

Read the detailed description

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

Being tested
Virtual Community Intervention, Standard of Care
Medical subject headings
HIV Infections, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Community InterventionBehavioural

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

  • Standard of CareBehavioural

    health websites and county information provided to participants

Study groups in NCT05363865
Study groupRoleWhat they receive
Virtual Community InterventionExperimentalParticipants will participate in an online community with structured sessions as well as the ability to communicate freely with others.
Receives: Behavioral: Virtual Community Intervention
Standard of CareActive comparatorParticipants will be exposed to what's disseminated within their communities
Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test HIV

    Self-request of HIV test and confirmation of completion.

    Binary (Yes/No)

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

  2. Test HCV

    Self-request of HCV test and confirmation of completion.

    Binary (Yes/No)

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

  3. Know HIV Status

    Self-report of HIV status understanding.

    Binary (I tested positive for HIV; I tested negative for HIV.)

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

  4. Know HCV Status

    Self-report of HCV status understanding.

    Binary (I tested positive for HCV; I tested negative for HCV.)

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

  5. Receive HIV Treatment

    Self-report of HIV treatment reception.

    Binary (Yes/No)

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

  6. Receive HCV Treatment

    Self-report of HCV treatment reception.

    Binary (Yes/No)

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

  7. 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)

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

  8. Use syringe services (e.g., exchange)

    Self-report of using a syringe service program.

    Binary (Yes/No)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  9. Disinfect injection equipment

    Self-report of injection tool cleaning prior to use.

    Binary (Yes/No)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  10. New Social Connections

    Self-report of new social connections made with others in the community.

    Continuous (Numeric)

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

  11. Renewed Social Connections

    Self-report of reconnecting with previously distant community members.

    Continuous (Numeric)

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

  12. 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)

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

  13. Discovering services or groups

    Self-report of newly discovered social services or groups in their communities.

    Binary (Yes/No)

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

  14. Joining groups, organizations, or activities

    Self-report of newly joined groups, organizations, or activities in the community.

    Binary (Yes/No)

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

  15. Encouraging others to test for HIV/HCV

    Self-report of instances where individuals suggest or encourage HIV/HCV testing.

    Binary (Yes/No)

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

  16. 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)

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

  17. 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)

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

Secondary outcomes (29)
  1. Use PrEP

    Self-report of PrEP use.

    Binary (Yes/No)

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

  2. Use a condom during sex

    Self-report of condom use during sex.

    Scale (Never; Sometimes; Almost always; Always)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  3. Support for another with a health issue

    Self-report of supporting others as they attend to a health issue.

    Binary (Yes/No)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

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

    Self-report of providing support for someone with SUD.

    Binary (Yes/No)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

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

    Self-report of providing support for someone with a past SUD.

    Binary (Yes/No)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  6. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  7. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  8. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  9. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  10. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  11. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  12. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  13. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  14. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  15. 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)

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

  16. Take a flu shot during the most recent season

    Self-report of received influenza vaccine shots, with most recent shot date.

    Binary (Yes/No)

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

  17. Carry Naloxone

    Self-report of frequency that an individual has Naloxone on their person.

    Binary (Yes/No)

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

  18. 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)

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

  19. Has someone administered Naloxone on you?

    Self-report of another using Naloxone on the individual.

    Binary (Yes/No)

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

  20. Test for COVID-19

    Self-report of COVID-19 testing.

    Binary (Yes/No) Continuous (Numerical)

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

  21. Test for M-pox

    Self-report of M-pox testing received.

    Binary (Yes/No)

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

  22. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  23. 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)

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

  24. 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)

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

  25. Use someone else's syringe

    Self-report of sharing needles with another person.

    Continuous (Numerical)

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

  26. Complete Narcan training

    Completion of requested Narcan Training.

    Binary (Yes/No)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  27. Requesting safe-injection supplies

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

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

  28. Support for medication assisted treatment (MAT)

    Self-report of support for MAT.

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

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

  29. 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)

    Measured: Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), Immediate Follow-Up (3 Weeks), 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start12 Jun 2023
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
Clusters will be randomized to either the intervention or the standard of care.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363865
Sponsor's protocol ID
390234
Status last verified
Mar 2026
First submitted
21 Apr 2022
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Community Intervention in people with HIV Infections and Hepatitis C Virus Infection, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test HIV (time frame: Baseline, Immediate Follow-Up (3 Weeks), 3 months, 6 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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