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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new online community intervention to help prevent HIV and Hepatitis C in areas of Appalachia and the Midwest where injection drug use is linked to these infections. Participants will either join a virtual community with structured sessions and open communication or receive the standard information available in their communities (standard of care). It targets individuals living in specific zip codes with a history of using or not using illicit drugs (excluding marijuana). As an unphased trial, this study offers a unique opportunity to contribute to innovative prevention strategies in the community.

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 prior data suggests that this virtual community intervention is safe for participants?

Research has shown that online programs can be safe and helpful for people with health needs like HIV and Hepatitis C. Studies have found that these digital platforms help individuals access health services and connect with others who have similar experiences. Importantly, no reports have indicated harmful side effects from using online communities for health purposes.

In this trial's Virtual Community Intervention, participants will join online sessions and can chat freely with others. This method has previously improved health knowledge and reduced stigma around diseases like Hepatitis C. Overall, evidence suggests that this type of online community is well-received and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Community for HIV & Hepatitis C Prevention because it leverages a virtual community intervention, offering a fresh approach compared to traditional methods like medication and in-person counseling. Unlike standard options that often focus on direct medical treatment or face-to-face interactions, this intervention provides structured online sessions coupled with the freedom to engage with peers. This digital method could enhance accessibility and support for participants, particularly those who may face barriers to in-person care, ultimately aiming to improve prevention and awareness outcomes in a more connected and flexible environment.

What evidence suggests that the Virtual Community Intervention could be effective for HIV and Hepatitis C prevention?

This trial will compare a Virtual Community Intervention with the Standard of Care for HIV and Hepatitis C prevention. Research has shown that online community programs, like the Virtual Community Intervention in this trial, can increase patient engagement in healthcare. For HIV prevention, digital tools have helped individuals manage their health better, even if they haven't always directly reduced infection rates. For hepatitis C, community-based methods have increased testing and access to care, which are crucial steps in disease prevention. Digital tools can also educate people on avoiding infection risks safely. Overall, these strategies aim to empower individuals to make safer health choices. ^{3 6 7 8 9}

Who Is on the Research Team?

Dolores Albarracin, PhD

Principal Investigator

Univ. of Pennsylvania

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8813706/

Effectiveness of eHealth Interventions for HIV Prevention ...

We found that eHealth interventions deployed in SSA increased engagement in HIV management behaviours but did not significantly impact HIV prevention behaviours ...

2.

withpower.com

withpower.com/trial/phase-2-and-3-hepatitis-c-virus-hcv-infection-2023-b847a

Digital Community for HIV & Hepatitis C Prevention

What data supports the effectiveness of the Virtual Community Intervention treatment for HIV & Hepatitis C prevention? Research shows that using mobile ...

3.

academic.oup.com

academic.oup.com/ofid/article/12/8/ofaf412/8220616

Hepatitis C Virus (HCV) Clearance Cascade for Persons With ...

Using surveillance data to create jurisdictional HCV clearance cascades, we found that HCV clearance rates for HIV/HCV coinfected persons ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S258953702500166X

Community engagement and chronic viral hepatitis public ...

This review indicated that community-engaged interventions significantly improved HBV vaccine completion, HBV/HCV test uptake, HBV/HCV linkage to care, HBV/HCV ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05497388

Efficacy of Serious Game Interventions on HCV Education ...

Without being exposed to real risks, players can simulate the consequences of various risks and corresponding prevention methods to prevent Motivate learners to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6694728/

A Mobile Health Intervention to Improve Hepatitis C ...

This study will contribute novel data to better understand whether mobile health applications can support the complex health needs of people ...

7.

unaids.org

unaids.org/sites/default/files/media_asset/policy-brief_virtual-interventions_en.pdf

POLICY BRIEF - Virtual interventions in response to HIV, ...

Programmes can design flexible self-care pathways for clients to access services for HIV, sexually transmitted infections, tuberculosis (TB), viral hepatitis.

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1111/phn.13364

A community‐based participatory research approach to ...

This study examined hepatitis C knowledge, stigma, and behaviors that increase the risk of acquiring HCV among PWIS in South Central Indiana.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12163864/

A Longitudinal Study Based on Electronic Medical Records

Our study suggests that the intervention had a robust immediate effect, which was maintained in the post‐intervention period, thus highlighting ...