Digital Community to Improve Health in Rural Areas

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05363865
Collaborator
West Virginia University (Other)
2,400
2
15

Study Details

Study Description

Brief Summary

The study is a cluster randomized controlled trial developed in counties located in Appalachia and the Midwest. Counties are selected to have high risk for HIV and HCV infection associated with injection drug use.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Community Intervention
  • Behavioral: Standard of Care
Phase 2/Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2400 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Clusters will be randomized to either the intervention or the standard of care.Clusters will be randomized to either the intervention or the standard of care.
Masking:
Single (Outcomes Assessor)
Masking Description:
the outcomes assessor will be unaware of experimental condition.
Primary Purpose:
Prevention
Official Title:
Digital, Community-Led, Social Action Initiative to Reduce Opioid Vulnerability and HIV/HCV in Rural Areas of the Midwest and Appalachia
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Community Intervention

Participants will participate in a community with structured sessions as well as the ability to communicate freely with others.

Behavioral: Virtual Community Intervention
Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems

Active Comparator: Standard of Care

Participants will be exposed to what's disseminated within their communities

Behavioral: Standard of Care
health websites and county information provided to participants

Outcome Measures

Primary Outcome Measures

  1. Voluntary self-HIV test [4 months]

    self-testing procedures will determine how many tests participants in which condition perform

  2. Voluntary self-HIV test [8 months]

    self-testing procedures will determine how many tests participants in which condition perform

  3. Voluntary self-HIV test [12 months]

    self-testing procedures will determine how many tests participants in which condition perform

  4. Voluntary self-HCV test [4 months]

    self-testing procedures will determine how many tests participants in which condition perform

  5. Voluntary self-HCV test [8 months]

    self-testing procedures will determine how many tests participants in which condition perform

  6. Voluntary self-HCV test [12 months]

    self-testing procedures will determine how many tests participants in which condition perform

Secondary Outcome Measures

  1. use of harm reduction measures [4 months]

    self-report scale of number of times syringe exchange services and drug treatment were used, as well as frequency participants carry Narcan (Average of items)

  2. use of harm reduction measures [8 months]

    self-report scale of number of times syringe exchange services and drug treatment were used, as well as frequency participants carry Narcan (Average of items)

  3. use of harm reduction measures [12 months]

    self-report scale of number of times syringe exchange services and drug treatment were used, as well as frequency participants carry Narcan (Average of items)

  4. Motivation to test [4 months]

    self-report scale of intentions to test for HIV/HCV (Average of items)

  5. Motivation to test [8 months]

    self-report scale of intentions to test for HIV/HCV (Average of items)

  6. Motivation to test [12 months]

    self-report scale of intentions to test for HIV/HCV (Average of items)

  7. Motivation to engage in preventive behaviors [4 months]

    self-report scale of intentions to prevent HIV/HCV (Average of items)

  8. Motivation to engage in preventive behaviors [8 months]

    self-report scale of intentions to prevent HIV/HCV (Average of items)

  9. Motivation to engage in preventive behaviors [12 months]

    self-report scale of intentions to prevent HIV/HCV (Average of items)

  10. Motivation to use harm reduction measures [4 months]

    self-report scale of intentions to engage in harm reduction (Average of items)

  11. Motivation to use harm reduction measures [8 months]

    self-report scale of intentions to engage in harm reduction (Average of items)

  12. Motivation to use harm reduction measures [12 months]

    self-report scale of intentions to engage in harm reduction (Average of items)

  13. Opioid adverse events [4 months]

    self-report scale about number of overdoses

  14. Opioid adverse events [8 months]

    self-report scale about number of overdoses

  15. Opioid adverse events [12 months]

    self-report scale about number of overdoses

  16. Other opioid adverse events [4 months]

    self-report scale about number of number of health problems associated with substance use other than overdoses

  17. Other opioid adverse events [8 months]

    self-report scale about number of number of health problems associated with substance use other than overdoses

  18. Other opioid adverse events [12 months]

    self-report scale about number of number of health problems associated with substance use other than overdoses

  19. Behavioral skills relevant to testing for HIV/HCV [4 months]

    self-report scale of resources, help seeking, and knowledge that facilitate testing (Average of items)

  20. Behavioral skills relevant to testing for HIV/HCV [8 months]

    self-report scale of resources, help seeking, and knowledge that facilitate testing(Average of items)

  21. Behavioral skills relevant to testing for HIV/HCV [12 months]

    self-report scale of resources, help seeking, and knowledge that facilitates testing (Average of items)

  22. Behavioral skills relevant to engaging in preventive behaviors [4 months]

    self-report scale of resources, help seeking, and knowledge that facilitates prevention (Average of items)

  23. Behavioral skills relevant to engaging in preventive behaviors [8 months]

    self-report scale of resources, help seeking, and knowledge that facilitates prevention (Average of items)

  24. Behavioral skills relevant to engaging in preventive behaviors [12 months]

    self-report scale of resources, help seeking, and knowledge that facilitates prevention (Average of items)

  25. Behavioral skills relevant to harm reduction [4 months]

    self-report scale of resources, help seeking, and knowledge that facilitates harm reduction (Average of items)

  26. Behavioral skills relevant to harm reduction [8 months]

    self-report scale of resources, help seeking, and knowledge that facilitates harm reduction (Average of items)

  27. Behavioral skills relevant to harm reduction [12 months]

    self-report scale of resources, help seeking, and knowledge that facilitates harm reduction (Average of items)

  28. Motivation to support harm reduction policies in the community [4 months]

    self-report scale of intentions to support harm reduction services in the county (Average of items)

  29. Motivation to support harm reduction policies in the community [8 months]

    self-report scale of intentions to support harm reduction services in the county (Average of items)

  30. Motivation to support harm reduction policies in the community [12 months]

    self-report scale of intentions to support harm reduction services in the county (Average of items)

  31. Motivation to support access to health services for people using drugs [4 months]

    self-report scale of intentions to support health services for people using drugs in the county (Average of items)

  32. Motivation to support access to health services for people using drugs [8 months]

    self-report scale of intentions to support health services for people using drugs in the county (Average of items)

  33. Motivation to support access to health services for people using drugs [12 months]

    self-report scale of intentions to support health services for people using drugs in the county (Average of items)

  34. Stigma of substance use [4 months]

    self-report scale of substance use (Average of items)

  35. Stigma of substance use [8 months]

    self-report scale of substance use (Average of items)

  36. Stigma of substance use [12 months]

    self-report scale of substance use (Average of items)

  37. Stigma of HIV [4 months]

    self-report scale of HIV stigma (Average of items)

  38. Stigma of HIV [8 months]

    self-report scale of HIV stigma (Average of items)

  39. Stigma of HIV [12 months]

    self-report scale of HIV stigma (Average of items)

  40. Loneliness [4 months]

    self-report loneliness scale (Average of items)

  41. Loneliness [8 months]

    self-report loneliness scale (Average of items)

  42. Loneliness [12 months]

    self-report loneliness scale (Average of items)

  43. Social isolation [4 months]

    self-report scale of frequency of social contact (Sum of all contacts)

  44. Social isolation [8 months]

    self-report scale of frequency of social contact (Sum of all contacts)

  45. Social isolation [12 months]

    self-report scale of frequency of social contact (Sum of all contacts)

  46. Social Support [4 months]

    self-report scale of frequency of emotional, instrumental, and cognitive social support (Sum of all contacts)

  47. Social Support [8 months]

    self-report scale of frequency of emotional, instrumental, and cognitive social support (Sum of all contacts)

  48. Social Support [12 months]

    self-report scale of frequency of emotional, instrumental, and cognitive social support (Sum of all contacts)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Lives in target zip codes Half not using illicit substances in the last year Half injecting illicit substances in the last year

-

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania
  • West Virginia University

Investigators

  • Principal Investigator: e: Dolores Albarracin, PhD, Univ. of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05363865
Other Study ID Numbers:
  • 390234
First Posted:
May 6, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022