Digital Community for HIV & Hepatitis C Prevention

Overseen By Christopher J Quasti, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 18, Not in target zip codes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

459 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Virtual Community Intervention treatment for HIV & Hepatitis C prevention?

Research shows that using mobile technology and social media can effectively increase HIV and Hepatitis C testing and awareness. For example, a mobile intervention kit was found to be highly acceptable among people who inject drugs, leading to increased testing and knowledge. Additionally, social media interventions have shown promise in spreading health information and encouraging behavior change in community settings. ^{1 2 3 4 5}

Is the Digital Community for HIV & Hepatitis C Prevention generally safe for humans?

The Mobile Intervention Kit (MIK), a similar digital community intervention, was found to be feasible and highly acceptable among people who inject drugs, with no reported safety concerns. It helped increase knowledge about overdose prevention and HIV/HCV testing, suggesting it is generally safe for use in community settings. ^{2 6 7 8 9}

How does the Virtual Community Intervention treatment for HIV & Hepatitis C prevention differ from other treatments?

The Virtual Community Intervention is unique because it uses digital platforms to create a supportive online community, leveraging peer-to-peer connections to enhance HIV and Hepatitis C prevention efforts. This approach differs from traditional treatments by focusing on social interaction and community support rather than solely on medical or pharmaceutical interventions. ^{2 10 11 12 13}

Research Team

Dolores Albarracin, PhD

Principal Investigator

Univ. of Pennsylvania

Eligibility Criteria

This trial is for adults living in specific high-risk areas of Appalachia and the Midwest, where there's a concern about HIV and Hepatitis C due to injection drug use. It includes those who have used illicit substances within the last month as well as those who haven't in the past year.

Inclusion Criteria

Half using illicit substances in the last month

Lives in target zip codes

Half not using illicit substances in the last year

Exclusion Criteria

Not in target zip codes

I am younger than 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a virtual community intervention with structured sessions and communication

6 months

Online sessions

Immediate Follow-up

Participants are monitored for immediate outcomes after intervention sessions

3 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes at 3 and 6 months

6 months

Treatment Details

Interventions

• Standard of Care
• Virtual Community Intervention

Trial Overview The study tests a 'Virtual Community Intervention' against the usual health practices (Standard of Care) to see if it can improve health outcomes related to infectious diseases like HIV and Hepatitis C in rural communities.

Participant Groups

Group I: Virtual Community Intervention Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Findings from Research

The Mobile Intervention Kit (MIK) is a tablet-based program that effectively combines overdose prevention training with HIV and HCV testing, showing high acceptability among people who inject drugs in a Bronx outreach program.

Participants demonstrated significant increases in knowledge about overdose prevention and testing procedures after using the MIK, indicating its potential as a valuable tool for addressing opioid overdose and viral infections in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Technology to Increase HIV/HCV Testing and Overdose Prevention/Response among People Who Inject Drugs. Aronson, ID., Bennett, A., Marsch, LA., et al.[2020]

The A-CHESS mobile health application was adapted to include an HCV intervention, providing educational resources and tailored support to improve HCV screening and treatment among individuals with opioid use disorder, with 416 participants enrolled in the study.

Preliminary data showed that among those who had ever tested HCV antibody-positive, a significant proportion were linked to medical care and treated, indicating that integrating HCV services into addiction treatment programs may enhance health outcomes for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. Hochstatter, KR., Gustafson, DH., Landucci, G., et al.[2020]

In a review of three randomized trials and two cohort studies involving microbicide candidates in sub-Saharan Africa, the incidence of social harms related to trial participation was found to be low, ranging from 1.10 to 3.25 per 100 person-years.

Most reported social harms were linked to male partners rather than community stigma, highlighting the importance of monitoring these partner-related issues to ensure the safety and ethical conduct of HIV prevention research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social harms in female-initiated HIV prevention method research: state of the evidence. Montgomery, ET., Roberts, ST., Nel, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Presenting a conceptual framework for an HIV prevention and care continuum and assessing the feasibility of empirical measurement in Estonia: A case study. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Technology to Increase HIV/HCV Testing and Overdose Prevention/Response among People Who Inject Drugs. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Methods for measuring diffusion of a social media-based health intervention. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

An interrupted time series evaluation of a hepatitis C intervention for persons with HIV. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Innovative community-based educational face-to-face intervention to reduce HIV, hepatitis C virus and other blood-borne infectious risks in difficult-to-reach people who inject drugs: results from the ANRS-AERLI intervention study. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

The staying safe intervention: training people who inject drugs in strategies to avoid injection-related HCV and HIV infection. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Knowledge of hepatitis among active drug injectors at a syringe exchange program. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Social harms in female-initiated HIV prevention method research: state of the evidence. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Developing community networks to deliver HIV prevention interventions. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Peer Group Focused eHealth Strategies to Promote HIV Prevention, Testing, and Care Engagement. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Current trends in Internet- and cell phone-based HIV prevention and intervention programs. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

A CBPR partnership increases HIV testing among men who have sex with men (MSM): outcome findings from a pilot test of the CyBER/testing internet intervention. [2022]