Digital Community to Improve Health in Rural Areas

Not Applicable

Active, not recruiting

• Conditions: Hepatitis C Virus Infection; HIV Infections
• Interventions: Behavioral: Standard of Care; Behavioral: Virtual Community Intervention

• Registration Number: NCT05363865
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-06
• Study Start: 2023-06-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-07-21
• Study Completion: 2025-07-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 459

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Participants will be exposed to what's disseminated within their communities
Virtual Community Intervention	Virtual Community Intervention	Participants will participate in an online community with structured sessions as well as the ability to communicate freely with others.

Primary Outcome Measures

Name	Time	Method
Composite of Six Yes/No Behaviors Promoted by Intervention	Baseline, Session 2 [Experimental Condition Only], 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)

Secondary Outcome Measures

Name	Time	Method
HIV and HCV Testing	Baseline [Control not offered testing at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months	Measures: Test for HIV; Test for HCV; Binary (Yes/No)
HIV Prevention Behaviors	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months	Measures: If they have HIV risk: Using PrEP (Pre-Exposure Prophylaxis); Binary (Yes/No); Use a condom when you had sex; Continuous (Numeric); Use of syringe service programs; Binary (Yes/No); Disinfecting injection equipment; Binary (Yes/No)
Requesting Naloxone (Narcan)	Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months	Measures: If your state allows it, would you like us to send you Narcan/naloxone?; Binary (Yes/No)
Carrying Naloxone (Narcan)	Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months	Measures: Carry Naloxone Frequency; Scale (Never; Sometimes; Often; Always)
Making Social Connections (New or Reestablished)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months	Measures: How many new social connections were established (since the beginning of the study)?; How many old social connections were re-established (since the beginning of the study)?; Continuous (Numeric)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States