Health Communication for HIV/AIDS and Hepatitis C

Overseen by Roland C Merchant, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: HIV positive, HCV positive, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

A major impediment to emergency department (ED)-based HIV/HCV screening success is that often ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01 project, the research team will assess how well a promising, easy-to-use, one-time, minimal-training-needed, very brief persuasive health communication intervention (PHCI) increases acceptance of testing among adult ED patients who either currently, formerly or never injected drugs and initially declined HIV/HCV screening. The research team will conduct a randomized, controlled trial (RCT) at EDs within the Mount Sinai Health System to compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU) history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history cohort, the research team will randomly assign participants (1:1:1) to a PHCI delivered by: (1) a video with captions, (2) a video without captions, (3) an HIV/HCV counselor. This R01 project will be conducted at Mount Sinai affiliate hospitals EDs. For Aim 2, the research team will determine if screening acceptance is similar across IDU history cohorts. For Aim 3, the research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort.

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 treatment Persuasive Health Communication Intervention for HIV/AIDS and Hepatitis C?

Research shows that health communication can improve HIV/AIDS outcomes by enhancing knowledge, attitudes, and behaviors related to the disease. Effective communication can lead to better adherence to treatment and timely care, which are crucial for managing HIV/AIDS. ^{1 2 3 4 5}

Is the Persuasive Health Communication Intervention safe for humans?

The research articles reviewed do not provide specific safety data for the Persuasive Health Communication Intervention or similar treatments. They focus on how health risk communication can influence behavior and perceptions, but do not address safety concerns directly. ^{6 7 8 9 10}

How does health communication differ from other treatments for HIV/AIDS and Hepatitis C?

Health communication is unique because it focuses on improving understanding and engagement between patients, healthcare providers, and communities, rather than directly treating the virus. It enhances HIV/AIDS outcomes by influencing knowledge, attitudes, and behaviors, and supports the entire care continuum through education, counseling, and community support, which is different from traditional medical treatments. ^{1 4 11 12 13}

Research Team

Roland C Merchant, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults over 18 who speak English or Spanish, have not been tested for HIV/HCV in the past year, and are not currently infected with or being treated for these viruses. It's aimed at those who initially declined testing in the emergency department.

Inclusion Criteria

I can speak English or Spanish and can consent to participate.

I am 18 years old or older.

Not HIV AND HCV infected/Antibody+ (per EHR review and patient report)

Exclusion Criteria

Has tested for HIV or HCV in the past 12 months

HIV or HCV positive

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Immediate

1 visit (in-person)

Intervention

Participants receive a one-time persuasive health communication intervention to increase acceptance of HIV/HCV testing

Less than 30 minutes

1 visit (in-person)

Data Collection

Data is collected using the QDS™ program on a tablet computer during the intervention

Immediate

1 visit (in-person)

Follow-up

No research-related follow-ups needed as all activities occur during the initial visit

Treatment Details

Interventions

• Persuasive Health Communication Intervention (Behavioural Intervention)

Trial Overview The study tests a persuasive health communication intervention to increase acceptance of HIV/HCV screening. Participants will be randomly assigned to receive this intervention either through a video or directly from an HIV/HCV counselor.

Participant Groups

Group I: Persuasive Health Communication Intervention delivered in video format with captions Active Control 1 Intervention

A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.

Group II: Persuasive Health Communication Intervention delivered in video format without captions Active Control 1 Intervention

A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.

Group III: Persuasive Health Communication Intervention delivered by Health Educator Active Control 1 Intervention

Healthcare provider educator getting patients screened for HIV/HCV.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

Health communication plays a crucial role in improving HIV/AIDS outcomes by influencing knowledge, attitudes, and behaviors related to the disease, as demonstrated through a review of various communication strategies and their impact on the HIV/AIDS continuum of care.

The article highlights four main functions of health communication—information delivery, persuasion, social connection, and cultural expression—that can enhance service delivery and adherence to treatment, illustrated by a case study from the New York City Health Department between 2005 and 2013.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is health communication and how does it affect the HIV/AIDS continuum of care? A brief primer and case study from New York City. Storey, D., Seifert-Ahanda, K., Andaluz, A., et al.[2020]

A health communication campaign using instructional booklets and telephone consultations effectively changed dietary attitudes and behaviors in 68 patients with hyperlipoproteinemia, as indicated by responses from 56 participants who completed a follow-up questionnaire.

The combination of mass media messages and interpersonal communication (telephone consultations) led to greater changes in attitudes towards food, suggesting that such strategies can enhance dietary consultations, especially for patients with limited personal contact opportunities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving dietary education for patients with hyperlipidemia. Buller, AC.[2007]

This special issue presents nine studies that analyze the effectiveness of health communication strategies, including health education and promotion, highlighting their impact on consumer awareness and lifestyle changes.

The research emphasizes the importance of methodological rigor in health communication studies, with applications aimed at improving clinical health promotion and patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health communication research. Aarva, P., de Haes, W., Visser, A.[2019]

Effective health communication is essential for ensuring that practitioners, policymakers, and patients understand each other, which is crucial for promoting health and improving healthcare outcomes, especially in HIV treatment.

The supplement highlights various studies that address health communication challenges in the HIV continuum of care, emphasizing its role in reducing losses at each stage and supporting the global 90-90-90 treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Communication and the HIV Continuum of Care. Vermund, SH., Mallalieu, EC., Van Lith, LM., et al.[2020]

Effective health communication significantly impacts people's health decisions and perceptions, highlighting the need for strategies that are tailored to specific target groups.

The article emphasizes the importance of understanding attention processes, potential negative effects, and social influences in health communication, advocating for more evidence-based approaches to improve these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effective health communication: Foundations, barriers, and success factors from a communication science perspective]. Hastall, MR.[2020]

Effective health communication is crucial for educating the public about health risks and motivating them to adopt healthier behaviors, as demonstrated through the example of HIV/AIDS prevention in the 1980s.

The media plays a significant role in shaping public perception of health risks, and understanding past experiences with risk communication can help inform strategies for addressing future health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Communication of health risks: the example of HIV/AIDS prevention]. Lehmann, H., Töppich, J.[2016]

Health risk communication, particularly through gain-framed messaging, has shown a positive effect on smoking cessation among individuals with substance use problems, based on a systematic review of five unique studies.

The review highlights the need for further research, as the current studies had varied methods and measures, indicating that more robust randomized controlled trials are necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication of health risk in substance-dependent populations: A systematic review of randomised controlled trials. Goh, MCW., Kelly, PJ., Deane, FP., et al.[2022]

Providing tailored risk information can effectively change individuals' perceptions of risk, which is a crucial first step in initiating health behavior changes.

There is limited evidence directly linking altered risk perceptions to changes in behavior, but future interventions should focus on personalized feedback about risk and individual readiness for change to enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of risk communication on risk perceptions: the significance of individual differences. Gerrard, M., Gibbons, FX., Reis-Bergan, M.[2019]

Different formats of risk communication are essential to effectively convey health risks related to eating noncommercial Great Lakes fish, as many anglers have varying needs for understanding the information.

Using a combination of qualitative and quantitative data, along with diagrams and a cajoling tone, is generally more effective in helping audiences make informed decisions about fish consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating risk communication: examining target audience perceptions about four presentation formats for fish consumption health advisory information. Connelly, NA., Knuth, BA.[2019]

The study involved 207 ART-naïve HIV-positive patients in Northwest Ethiopia and found that using pictograms significantly improved patients' ability to identify specific antiretroviral medications and associated adverse drug reactions (ADRs).

Patients who received pictorial medication information were 4.3 times more likely to identify diarrhea as an ADR compared to those who did not receive pictograms, suggesting that visual aids can enhance ADR reporting, especially in populations with limited literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of pictogram intervention in the identification and reporting of adverse drug reactions in naïve HIV patients in Ethiopia: a cross-sectional study. Gebreyohannes, EA., Bhagavathula, AS., Abegaz, TM., et al.[2022]

Health communication is crucial in enhancing HIV treatment, care, and prevention, particularly through interpersonal methods like individual and group counseling, which improve patient engagement and care uptake.

Community treatment supporters play a vital role by providing education and support, reducing the burden on healthcare providers, and utilizing mobile technologies for cost-effective communication throughout the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A role for health communication in the continuum of HIV care, treatment, and prevention. Tomori, C., Risher, K., Limaye, RJ., et al.[2021]

Effective communication is crucial for successful interventions aimed at reducing HIV infection risk, highlighting the need for tailored messaging based on audience context.

The paper emphasizes the importance of integrating communication theory and social marketing strategies into intervention development to enhance behavior change and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior change communication strategies. Aggleton, P.[2005]

The study evaluated audience reactions to five draft HIV prevention messages aimed at people living with HIV, finding that most participants had favorable attitudes towards all concepts, indicating strong potential for future health communication campaigns.

Sociodemographic factors had less influence on message perceptions compared to individual attitudes and beliefs, suggesting that tailoring messages based on these factors may be more effective than demographic targeting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audience reactions and receptivity to HIV prevention message concepts for people living with HIV. Uhrig, JD., Bann, CM., Wasserman, J., et al.[2010]

References

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

What is health communication and how does it affect the HIV/AIDS continuum of care? A brief primer and case study from New York City. [2020]

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

Improving dietary education for patients with hyperlipidemia. [2007]

3. Ireland pubmed.ncbi.nlm.nih.gov

Health communication research. [2019]

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

Health Communication and the HIV Continuum of Care. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Effective health communication: Foundations, barriers, and success factors from a communication science perspective]. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

[Communication of health risks: the example of HIV/AIDS prevention]. [2016]

7. Australia pubmed.ncbi.nlm.nih.gov

Communication of health risk in substance-dependent populations: A systematic review of randomised controlled trials. [2022]

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

The effect of risk communication on risk perceptions: the significance of individual differences. [2019]

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

Evaluating risk communication: examining target audience perceptions about four presentation formats for fish consumption health advisory information. [2019]

10. New Zealand pubmed.ncbi.nlm.nih.gov

The effectiveness of pictogram intervention in the identification and reporting of adverse drug reactions in naïve HIV patients in Ethiopia: a cross-sectional study. [2022]

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

A role for health communication in the continuum of HIV care, treatment, and prevention. [2021]

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

Behavior change communication strategies. [2005]

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

Audience reactions and receptivity to HIV prevention message concepts for people living with HIV. [2010]