Digital Community to Improve Health in Rural Areas

HIV Infections Clinical Trial

Official title:

Digital, Community-Led, Social Action Initiative to Reduce Opioid Vulnerability and HIV/HCV in Rural Areas of the Midwest and Appalachia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363865
• Other study ID #: 390234
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Dolores Albarracin, PhD
• Phone: 2178402383
• Email: dalba[@]upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis C
• Hepatitis C Virus Infection
• HIV Infections
• Infections

Intervention

Behavioral:
• Virtual Community Intervention
Modules of community building, HIV/HCV prevention, drug and service stigma, identification of mental health problems
• Standard of Care
health websites and county information provided to participants

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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