Digital Community to Improve Health in Rural Areas

NCT05363865 | Completed

• 1 other identifier: 390234
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Virus Infection; HIV Infections

Outcome Measures

Primary Outcomes (17)

• 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

• 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

Secondary Outcomes (29)

• Use PrEP

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

• 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

• 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

• 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

• 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

Other Outcomes (3)

• Composite of Six Yes/No Behaviors Promoted by Intervention

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

• Made at Least One New/Re-established Social Connection

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

• Social Support and Connection

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

Study Arms (2)

Virtual Community Intervention

EXPERIMENTAL

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

Behavioral: Virtual Community Intervention

Standard of Care

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

Interventions

Standard of Care BEHAVIORAL

health websites and county information provided to participants

Standard of Care

Virtual Community Intervention BEHAVIORAL

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

Virtual Community Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dolores Albarracin, PhD

  Univ. of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be unaware of the experimental condition.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clusters will be randomized to either the intervention or the standard of care.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 6, 2022
• Study Start: June 12, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)