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: Recruiting
• 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 (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dolores Albarracin, PhD; Phone Number: 2178402383; Email: dalba@upenn.edu
• Study Contact Backup: Name: Christopher J Quasti, PhD; Email: Cquasti@upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Recruiting
      • University of Pennsylvania
      • Contact: Dolores Albarracin, Ph.D.; Phone Number: 217-840-2383; Email: dalba@upenn.edu
      • Principal Investigator: Dolores Albarracin, Ph.D

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
HIV Testing and Treatment	Measures: Binary (Yes/No): Self-request HIV Test (First offered to Control at Immediate Follow-up) Test for HIV Receive HIV treatment if HIV positive If they test positive for HIV, receive a referral to HIV treatment. Self-report of receiving referral of HIV treatment.	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
HCV Testing and Treatment	Measures: Binary (Yes/No): Self-request HCV Test (First offered to Control at Immediate Follow-up) Test for HCV Receive HCV treatment if HCV positive If they test positive for HCV, receive a referral to HCV treatment. Self-report of receiving referral of HCV treatment.	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Harm Reduction and Substance Use Recovery Service Use	Measures: Binary (Yes/No): Self-request Narcan (Naloxone) (First offered to Control at Immediate Follow-up) If they inject drugs, using syringe services (e.g., exchange) Disinfect injection equipment (if using injection drugs) Use someone else's syringe (if using injection drugs) Complete Narcan training See a mental health professional if there are mental health concerns including substance use Attend a 12-step group if using or in recovery Attend another abstinence-based program if using or in recovery Attend a substance use treatment program that uses medications if using or in recovery Attend a faith-based substance use group Carry Naloxone Use Naloxone on someone If they have HIV risk, using PrEP (Pre-Exposure Prophylaxis) Use a condom when you had sex Continuous Research team reported referrals provided to participants in the categories of healthcare and mental health, and substance use recovery.	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Social Connection and Community Building	Measures: Continuous: In the past 3 months, how many new social connections were established (since the baseline)? In the past 3 months, how many old social connections were re-established (since the baseline)? Scale (Not at all; A little; Somewhat; A lot; A great deal): In the past 3 months, have you contributed to your town, neighborhood, community of friends, church, or other groups? In the past 3 months/Since the baseline, have you found out (did you) find out about organizations, groups, activities to join? Binary (Yes/No): In the past 3 months/Since the baseline, have you (did you) joined/join organizations, groups, activities?	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Social Connection and Community Building - 2	Measures: Binary (Yes/No): In the past 3 months/Since the baseline, have you (did you) encouraged/encourage others to test for HIV or HCV? In the past 3 months/Since the baseline, have you (did you) encouraged/encourage others to seek treatment for substance use or HIV/HCV? In the past 3 months/Since the baseline, have you (did you) discussed/discuss substance use issues with others? Support somebody who has a health issue Support somebody who is presently struggling with substance use Support somebody who has had struggles with substance use Support somebody who has a family member who has a substance use disorder	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Care Access	Measures: Binary (Yes/No): Receive COVID-19 vaccine(s) as currently required (measure past doses and date of last shot) Take a flu shot during the most recent season (measure month and year of last shot) Test for COVID-19 (ever, number of tests) (Continuous) Test for M-pox (ever)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Stigmatizing Conversational Language	Measures: Binary (Yes/No): Refrain from using hurtful language to refer to people with substance use disorder Refrain from using hurtful language to refer to people from other groups (e.g., religious) Intend to say something to intervene when someone uses hurtful language	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Substance Use	Measures: 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): Drink alcohol frequency Use substance without a prescription or more than prescribed Inject substances Binary (Yes/No): Has someone administered Naloxone on you?	Baseline, Session 2 [Experimental Condition Only], 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 (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

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 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Infections; Communicable Diseases; Hepatitis C
• 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