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Digital Community to Improve Health in Rural Areas

Primary Purpose

HIV Infections, Hepatitis C Virus Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Community Intervention
Standard of Care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Community Intervention

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Test HIV
Self-request of HIV test and confirmation of completion. Binary (Yes/No)
Test HCV
Self-request of HCV test and confirmation of completion. Binary (Yes/No)
Know HIV Status
Self-report of HIV status understanding. Binary (I tested positive for HIV; I tested negative for HIV.)
Know HCV Status
Self-report of HCV status understanding. Binary (I tested positive for HCV; I tested negative for HCV.)
Receive HIV Treatment
Self-report of HIV treatment reception. Binary (Yes/No)
Receive HCV Treatment
Self-report of HCV treatment reception. Binary (Yes/No)
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)
Use syringe services (e.g., exchange)
Self-report of using a syringe service program. Binary (Yes/No)
Disinfect injection equipment
Self-report of injection tool cleaning prior to use. Binary (Yes/No)
New Social Connections
Self-report of new social connections made with others in the community. Continuous (Numeric)
Renewed Social Connections
Self-report of reconnecting with previously distant community members. Continuous (Numeric)
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)
Discovering services or groups
Self-report of newly discovered social services or groups in their communities. Binary (Yes/No)
Joining groups, organizations, or activities
Self-report of newly joined groups, organizations, or activities in the community. Binary (Yes/No)
Encouraging others to test for HIV/HCV
Self-report of instances where individuals suggest or encourage HIV/HCV testing. Binary (Yes/No)
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)
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)

Secondary Outcome Measures

Use PrEP
Self-report of PrEP use. Binary (Yes/No)
Use a condom during sex
Self-report of condom use during sex. Scale (Never; Sometimes; Almost always; Always)
Support for another with a health issue
Self-report of supporting others as they attend to a health issue. Binary (Yes/No)
Support somebody who is presently struggling with substance use disorder
Self-report of providing support for someone with SUD. Binary (Yes/No)
Support somebody who has had struggles with substance use disorder
Self-report of providing support for someone with a past SUD. Binary (Yes/No)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Take a flu shot during the most recent season
Self-report of received influenza vaccine shots, with most recent shot date. Binary (Yes/No)
Carry Naloxone
Self-report of frequency that an individual has Naloxone on their person. Binary (Yes/No)
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)
Has someone administered Naloxone on you?
Self-report of another using Naloxone on the individual. Binary (Yes/No)
Test for COVID-19
Self-report of COVID-19 testing. Binary (Yes/No) Continuous (Numerical)
Test for M-pox
Self-report of M-pox testing received. Binary (Yes/No)
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)
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)
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)
Use someone else's syringe
Self-report of sharing needles with another person. Continuous (Numerical)
Complete Narcan training
Completion of requested Narcan Training. Binary (Yes/No)
Requesting safe-injection supplies
Request for wound-care kits for injection sites and/or syringe cleaning kits.

Full Information

First Posted
April 21, 2022
Last Updated
October 17, 2023
Sponsor
University of Pennsylvania
Collaborators
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT05363865
Brief Title
Digital Community to Improve Health in Rural Areas
Official Title
Digital, Community-Led, Social Action Initiative to Reduce Opioid Vulnerability and HIV/HCV in Rural Areas of the Midwest and Appalachia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
The study will randomize clusters with groups of participants to an intervention or a standard of care condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C Virus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Clusters will be randomized to either the intervention or the standard of care.
Masking
Outcomes Assessor
Masking Description
the outcomes assessor will be unaware of experimental condition.
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Community Intervention
Arm Type
Experimental
Arm Description
Participants will participate in a community with structured sessions as well as the ability to communicate freely with others.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants will be exposed to what's disseminated within their communities
Intervention Type
Behavioral
Intervention Name(s)
Virtual Community Intervention
Intervention Description
Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
health websites and county information provided to participants
Primary Outcome Measure Information:
Title
Test HIV
Description
Self-request of HIV test and confirmation of completion. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Test HCV
Description
Self-request of HCV test and confirmation of completion. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Know HIV Status
Description
Self-report of HIV status understanding. Binary (I tested positive for HIV; I tested negative for HIV.)
Time Frame
Baseline, 3 months, 6 months
Title
Know HCV Status
Description
Self-report of HCV status understanding. Binary (I tested positive for HCV; I tested negative for HCV.)
Time Frame
Baseline, 3 months, 6 months
Title
Receive HIV Treatment
Description
Self-report of HIV treatment reception. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Receive HCV Treatment
Description
Self-report of HCV treatment reception. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Receive Over-the-Counter Narcan
Description
Request to receive over-the-counter Narcan, depending on the ability to distribute Narcan in the state of residence. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Use syringe services (e.g., exchange)
Description
Self-report of using a syringe service program. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Disinfect injection equipment
Description
Self-report of injection tool cleaning prior to use. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
New Social Connections
Description
Self-report of new social connections made with others in the community. Continuous (Numeric)
Time Frame
Baseline, 3 months, 6 months
Title
Renewed Social Connections
Description
Self-report of reconnecting with previously distant community members. Continuous (Numeric)
Time Frame
Baseline, 3 months, 6 months
Title
Contributions to town, neighborhoods, and community
Description
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)
Time Frame
Baseline, 3 months, 6 months
Title
Discovering services or groups
Description
Self-report of newly discovered social services or groups in their communities. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Joining groups, organizations, or activities
Description
Self-report of newly joined groups, organizations, or activities in the community. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Encouraging others to test for HIV/HCV
Description
Self-report of instances where individuals suggest or encourage HIV/HCV testing. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Encouraging others to treat substance use disorder or HIV/HCV
Description
Self-report of instances where individuals suggest or encourage others to be treated for substance use disorder, HIV, or HCV. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Discuss substance use issues with others
Description
Self-report of instances where individual discusses substance use issues with other members of their community. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Use PrEP
Description
Self-report of PrEP use. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Use a condom during sex
Description
Self-report of condom use during sex. Scale (Never; Sometimes; Almost always; Always)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Support for another with a health issue
Description
Self-report of supporting others as they attend to a health issue. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Support somebody who is presently struggling with substance use disorder
Description
Self-report of providing support for someone with SUD. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Support somebody who has had struggles with substance use disorder
Description
Self-report of providing support for someone with a past SUD. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Support somebody who has a family member who has a substance use disorder
Description
Self-report of providing support for the relative of someone with SUD. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Refrain from using hurtful language to refer to people with substance use disorder
Description
Self-report of hurtful or stigmatizing language towards people with SUD. Scale (Never; Sometimes; Almost always; Always)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Refrain from using hurtful language to refer to people from other groups (e.g., religious)
Description
Self-report of hurtful or stigmatizing language towards people of other groups. Scale (Never; Sometimes; Almost always; Always)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Intention to intervene when someone uses hurtful language
Description
Self-report of behavioral intentions to prevent or intervene in hurtful or stigmatizing language. Scale (Never; Sometimes; Almost always; Always)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
See a mental health professional if there are mental health concerns including substance use
Description
Self-report of seeking professional help with mental health concerns. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Attend a 12-step group (if using substances or in recovery)
Description
Self-report of 12-step group attendance for people who use drugs or are in recovery. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Attend another abstinence-based program (if using substances or in recovery)
Description
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)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Attend a substance use treatment program that uses medications (if using substances or in recovery)
Description
Self-report of medication-assisted recovery program attendance for people who use drugs or are in recovery. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Attend a religious-based substance use group (if using substances or in recovery)
Description
Self-report of religious-based substance use group attendance. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Receive COVID-19 vaccine(s) as currently required (measure past and last shot)
Description
Self-report of received COVID-19 vaccine shots, with most recent shot date and number of shots. Binary (Yes/No) Date (YMD)
Time Frame
Baseline, 3 months, 6 months
Title
Take a flu shot during the most recent season
Description
Self-report of received influenza vaccine shots, with most recent shot date. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Carry Naloxone
Description
Self-report of frequency that an individual has Naloxone on their person. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Use Naloxone on someone
Description
Self-report of instances where Naloxone was used by the individual to address an overdose or suspected overdose. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Has someone administered Naloxone on you?
Description
Self-report of another using Naloxone on the individual. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Test for COVID-19
Description
Self-report of COVID-19 testing. Binary (Yes/No) Continuous (Numerical)
Time Frame
Baseline, 3 months, 6 months
Title
Test for M-pox
Description
Self-report of M-pox testing received. Binary (Yes/No)
Time Frame
Baseline, 3 months, 6 months
Title
Drink alcohol frequency
Description
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)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Use substance without a prescription or more than prescribed
Description
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)
Time Frame
Baseline, 3 months, 6 months
Title
Injection drug use
Description
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)
Time Frame
Baseline, 3 months, 6 months
Title
Use someone else's syringe
Description
Self-report of sharing needles with another person. Continuous (Numerical)
Time Frame
Baseline, 3 months, 6 months
Title
Complete Narcan training
Description
Completion of requested Narcan Training. Binary (Yes/No)
Time Frame
Baseline, Session 2 (~2 weeks, Experimental Group Only), Session 3 (~3 weeks, Experimental Group Only), 3 months, 6 months
Title
Requesting safe-injection supplies
Description
Request for wound-care kits for injection sites and/or syringe cleaning kits.
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Lives in target zip codes Half not using illicit substances in the last year Half using illicit substances in the last month Exclusion Criteria: Under the age of 18 Not in target zip codes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dolores Albarracin, PhD
Phone
2178402383
Email
dalba@upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher J Quasti, PhD
Email
Cquasti@upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores Albarracin, PhD
Organizational Affiliation
Univ. of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Albarracin, Ph.D.
Phone
217-840-2383
Email
dalba@upenn.edu
First Name & Middle Initial & Last Name & Degree
Dolores Albarracin, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Community to Improve Health in Rural Areas

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