Health Communication for HIV/AIDS and Hepatitis C

Overseen By Roland C Merchant, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: HIV positive, HCV positive, others

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

Compensation: Varies

Number of Visits: 3

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the frequency of emergency room patients agreeing to HIV and Hepatitis C testing. It will compare the effectiveness of a short, persuasive health message (Persuasive Health Communication Intervention) presented in three ways: a video with captions, a video without captions, or by a health educator. Suitable participants have not been tested for HIV or Hepatitis C in the past year and have previously declined screening. Participants must speak English or Spanish and should not already have HIV or Hepatitis C. The study takes place at Mount Sinai Health System emergency departments. As an unphased trial, it offers a unique opportunity to enhance public health communication strategies.

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 health communication intervention is safe?

Research shows that the Persuasive Health Communication Intervention (PHCI) helps people who initially declined HIV and Hepatitis C (HCV) tests reconsider their decision. Studies have found that this approach, whether presented through a video (with or without captions) or by a health educator, is not a medical treatment but a way to share information with patients.

PHCI is safe because it only involves sharing information, without any drugs, medical procedures, or physical interventions. Therefore, it carries no known risks or side effects. The focus is on effective communication to encourage testing, which is a simple and non-invasive process.

Overall, PHCI aims to make HIV and HCV testing more accepted by simplifying the information. Since it is not a medical treatment, it avoids the safety concerns associated with clinical trials involving medications or invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to encourage people to get screened for HIV and Hepatitis C. Unlike traditional methods that might involve pamphlets or direct conversations with healthcare providers, this trial uses persuasive videos with and without captions to influence decisions. It also incorporates a health educator to personally engage with patients. These innovative communication strategies aim to boost screening rates by making the information more engaging and accessible, potentially leading to earlier detection and better health outcomes.

What evidence suggests that this health communication intervention is effective for increasing HIV/HCV screening acceptance?

Research shows that the Persuasive Health Communication Intervention (PHCI) can increase the number of people who agree to HIV and Hepatitis C (HCV) testing in emergency departments. Studies have found that PHCI can change the minds of those who initially declined testing. In this trial, the intervention is offered in three ways: a video with captions, a video without captions, and a session with a health educator. Previous trials indicate that all three methods help more people agree to testing, even if they were hesitant at first. This evidence suggests that PHCI effectively encourages more people to get tested for these infections. ^{2 3 6 7 8}

Who Is on the Research Team?

Roland C Merchant, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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

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

Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)

Not tested for HIV OR HCV within the past 12 months (per EHR review and patient report)

Exclusion Criteria

Has tested for HIV or HCV in the past 12 months

HIV or HCV positive

Currently enrolled in another HIV or HCV research study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Persuasive Health Communication 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.

How Is the Trial Designed?

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+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11331935/

a randomised controlled trial study protocol We developed a brief persuasive health communication intervention (PHCI) designed to convince ED patients who had declined HIV/HCV testing to agree to be ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05968573?cond=hiv&aggFilters=status%3A

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

3. journalofscientificinnovationinmedicine.org journalofscientificinnovationinmedicine.org/articles/10.29024/jsim.206

Three Pilot Randomized Controlled Trials Evaluating a ... We created a persuasive health communication intervention (PHCI) designed to overcome ED patient reluctance to accept HIV/HCV testing.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39134444/

a randomised controlled trial study protocol - PubMed - NIH We developed a brief persuasive health communication intervention (PHCI) designed to convince ED patients who had declined HIV/HCV testing to agree to be ...

5. researchgate.net researchgate.net/publication/383084881_Testing_a_persuasive_health_communication_intervention_PHCI_for_emergency_department_patients_who_declined_rapid_HIVHCV_screening_a_randomised_controlled_trial_study_protocol

a randomised controlled trial study protocol We developed a brief persuasive health communication intervention (PHCI) designed to convince ED patients who had declined HIV/HCV testing to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05968573

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

7. annemergmed.com annemergmed.com/article/S0196-0644(24)00556-0/fulltext

98 Three Pilot Randomized Controlled Trials Evaluating a ... We created a persuasive health communication intervention (PHCI) designed to overcome ED patient reluctance to accept HIV/HCV testing.

8. mountsinai.org mountsinai.org/clinical-trials/persuasive-health-communication-intervention-for-hiv-hcv

Persuasive Health Communication Intervention for HIV/HCV It helps us understand how the site is used – what's working, what might be broken and what we should improve. A/B testing and personalizationWe'll use your ...