Digital Community to Improve Health in Rural Areas

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Hepatitis C Virus Infection
• Intervention / Treatment: Behavioral: Virtual Community Intervention; Behavioral: Standard of Care

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 511
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Experimental: Virtual Community Intervention; Participants will participate in an online 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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 Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: West Virginia University
• Investigators: Principal Investigator: Dolores Albarracin, PhD, Univ. of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Flaviviridae Infections; Hepatitis; HIV Infections; Hepatitis C; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 390234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No