Clinical trial NCT05363865: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Hepatitis C Virus Infection
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Clusters will be randomized to either the intervention or the standard of care.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of Six Yes/No Behaviors Promoted by Intervention
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Secondary outcomes:
measure: HIV and HCV Testing
timeFrame: Baseline [Control not offered testing at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: HIV Prevention Behaviors
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Requesting Naloxone (Narcan)
timeFrame: Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Carrying Naloxone (Narcan)
timeFrame: Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Making Social Connections (New or Reestablished)
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Other outcomes:
measure: Seeking Substance Use or Mental Health Treatment or Recovery Services
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Interacting Positively with People Who Use Substances During and Outside the Sessions and Drug Stigma
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Substance Use Without a Prescription or More Than Prescribed (With Baseline Level at 3 and 6 Months)
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Injection Substance Use (With Baseline Level at 3 and 6 Months)
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
measure: Seeking Treatment for HIV and HCV if Participant is Seropositive
timeFrame: Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Univ. of Pennsylvania
name: Dolores Albarracin, PhD
role: PRINCIPAL_INVESTIGATOR
References: