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: June 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
Other	Using Naloxone on Someone	Use of Naloxone to prevent overdose for another.; Binary (Yes/No)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Other	Contributions to town, neighborhood, community of friends, church, or other groups	Have you contributed to your town, neighborhood, community of friends, church, or other groups (including people with whom you interact in this study) (since the beginning of the study)?; Scale (Not at all; A little; Somewhat; A lot; A great deal)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Other	Discovering new organizations, groups, or activities	Have you found out (did you) find out about organizations, groups, activities to join (since the beginning of the study)?; Scale (Not at all; A little; Somewhat; A lot; A great deal)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Primary	HIV/HCV Testing and Treatment	Measures: Test for HIV Receive HIV treatment if HIV positive If they test positive for HIV, receive referral to HIV treatment. Self-report of receiving referral of HIV treatment.; Test for HCV Receive HCV treatment if HCV positive If they test positive for HCV, receive referral to HCV treatment. Self-report of receiving referral of HCV treatment.; Seeking treatment for HIV/HCV if they test positive; Binary (Yes/No)	Baseline [Control not offered testing at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Primary	HIV/HCV Prevention	Measures: If they have HIV risk, using PrEP (Pre-Exposure Prophylaxis); Binary (Yes/No); Use a condom when you had sex; Continuous (Numeric)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Primary	Overdose Prevention	Measures: If your state allows it, would you like us to send you Narcan/naloxone?; Binary (Yes/No); Carry Naloxone Frequency; Scale (Never; Sometimes; Often; Always)	Baseline[Control not offered Naloxone at baseline], Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Primary	Seeking Mental/Physical Health Treatment	Measures: See a mental health professional if there concerns or substance use Attend a 12-step group if previous substance use Attend another abstinence-based program if previous substance use Attend a substance use treatment program that uses medications if previous substance use Attend a faith-based substance use group; Binary (Yes/No); Research team reported referrals provided to participants healthcare and mental health/substance use recovery.; Continuous (Numeric)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Primary	Stigmatizing Language	Measures: 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; Scale (Never; Sometimes; Almost Always; Always); People who use drugs are to blame for their drug use. People who use drugs are dangerous. People who use drugs should be excluded from society. People with a mental health condition are to blame for their condition. People with a mental health condition are dangerous. People with a mental health condition should be excluded from society.; Scale (Strongly disagree; somewhat disagree; neither disagree not agree; somewhat agree; strongly agree)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Primary	Social Connections	Measures: How many new social connections were established (since the beginning of the study)? How many of the new social connections established since the beginning of the study are you still in touch with? How many old social connections were re-established (since the beginning of the study)? How many re-established social connections established since the beginning of the study are you still in touch with? How many people in your life who can do a favor for you (lend you money, run an errand)? How many people in your life can support you if you are sad, worried, or frustrated?; Continuous (Numeric); Have you (did you) joined/join organizations, groups, activities (since the beginning of the study)?; Binary (Yes/No)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Secondary	Substance Use	Measures: Use substance without a prescription or more than prescribed Inject substances; 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; 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)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Secondary	Syringe Use	Measures: If using injection drugs: Using syringe services (e.g., exchange) Disinfect injection equipment Use someone else's syringe; Binary (Yes/No)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months
Secondary	Policy Support	Measures: The government should punish people for using illicit drugs or drugs without a prescription To prevent the spread of disease, the government should provide clean syringes for people who inject drugs as a way of avoiding infections The government should pay for treatment for drug addiction when community members need treatment The government should provide free treatment for infections that result from drug use The government should jail people who use drugs illegally. The government should deal with drug misuse by supporting the use of medication that reduces addiction.; The government should deal with drug misuse by funding drug treatment programs that help people out of addiction.; Scale (Strongly disagree; somewhat disagree; neither disagree not agree; somewhat agree; strongly agree)	Baseline, Session 2 [Experimental Condition Only], Immediate Follow-Up (3 Weeks), 3 months, 6 months