Decision Aid for HIV Prevention

Recruiting at 2 trial locations

Overseen By Hannah Aston

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Under 18, Low exposure risk, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool designed to assist healthcare providers and patients in making informed decisions about using HIV Post-Exposure Prophylaxis (PEP), a treatment to prevent HIV after possible exposure. The tool provides personalized information and compares different priorities such as health, privacy, and cost to aid decision-making. Ideal participants are English-speaking individuals, 18 or older, seeking care after a sexual assault, and who meet the criteria for receiving HIV PEP within 72 hours of potential exposure. As an unphased study, this trial allows participants to contribute to innovative research that could improve decision-making tools for HIV prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your healthcare provider.

What prior data suggests that this decision aid is safe for use?

Research has shown that decision aids, like the one tested in this study, are generally safe to use in healthcare. A 2017 Cochrane review found that patients who used these aids felt more informed and less confused about their healthcare choices. This indicates that decision aids are safe, as they primarily help patients understand their options better.

This trial tests a digital tool to assist in decisions about HIV post-exposure prophylaxis (PEP). PEP is a treatment that can prevent HIV infection after possible exposure. The decision aid provides clear information about PEP's effectiveness, risks, and benefits, helping patients make informed choices with their healthcare providers.

Overall, using a decision aid is considered low-risk. It is designed to improve communication and decision-making, making it a safe addition to healthcare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for HIV Prevention because it offers a personalized and interactive approach to HIV post-exposure prophylaxis (PEP). Unlike traditional methods that rely solely on provider recommendations, this digital tool actively involves patients by incorporating their personal priorities and concerns, such as privacy and cost. The decision aid provides tailored HIV risk information and multimedia educational content, which helps patients make more informed decisions alongside their healthcare providers. By enhancing shared decision-making, this innovative approach has the potential to improve patient engagement and adherence to HIV prevention strategies.

What evidence suggests that this decision aid is effective for HIV prevention?

Research has shown that HIV post-exposure prophylaxis (PEP) is highly effective at preventing HIV if taken soon after exposure. Studies have found that PEP can be 99.5% effective when individuals complete the full treatment and avoid further risky behaviors. In this trial, the decision aid being tested is designed to help patients and healthcare providers make informed choices about using PEP by offering personalized information and feedback. This tool aims to improve understanding and use of PEP, potentially leading to better outcomes for people at risk of HIV. ^{1 2 3 4 5}

Who Is on the Research Team?

Jocelyn Anderson

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are seeking care after a sexual assault and meet CDC criteria for HIV post-exposure prophylaxis (PEP), which includes seeking care within 72 hours of potential exposure. Participants must be able to consent and participate in English.

Inclusion Criteria

You can understand and agree to be part of the study in English.

I am seeking care after a sexual assault.

I sought HIV prevention treatment within 72 hours after possible exposure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants use a digital, interactive patient-provider HIV PEP decision aid

Immediate

1 visit (in-person)

Treatment

Participants decide on and potentially initiate HIV PEP, which is taken for 28 days

4 weeks

Follow-up

Participants are monitored for HIV PEP completion and decisional conflict

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Patient-provider Decision Aid

Trial Overview The study is testing a digital decision aid designed to help patients and providers decide about taking HIV PEP after sexual assault. It includes clinical factors, risk information, education on PEP's effectiveness and risks, comparison of patient priorities, and tailored feedback.

How Is the Trial Designed?

Group I: decision aid Experimental Treatment 1 Intervention

A digital, interactive patient-provider HIV PEP decision aid. The decision aid will incorporate five sections of content: 1) key clinical factors input by providers; 2) tailored HIV risk sharing information; 3) standardized multimedia educational messaging regarding the effectiveness, risks, and benefits of HIV PEP; 4) direct comparisons of priorities (e.g., physical well-being - "I want to do everything I can to prevent HIV," privacy - "I don't want others to know about the exposure," or cost - "I can't afford the pills'') completed by patients; and 5) tailored feedback regarding patient priorities for use in shared clinical decision making.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

District of Columbia Forensic Nurse Examiners

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Patients using the arriba-lib decision aid reported high satisfaction with the shared decision-making process, with two-thirds expressing a desire for future consultations using the tool.

The study found that 80.7% of patients implemented their decisions made with the aid, indicating that the decision aid effectively supports adherence to treatment choices across diverse patient demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of shared decision making with reference to an electronic library of decision aids (arriba-lib) and its association to decision making in patients: an evaluation study. Hirsch, O., Keller, H., Krones, T., et al.[2021]

Patient decision aids significantly enhance the decision-making process for cancer patients, leading to better alignment between their choices and personal values, as evidenced by improved knowledge and accurate risk perception across 46 trials.

These aids also reduce decisional conflict and indecisiveness among patients, promoting a more patient-centered approach to cancer care compared to standard practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Effectiveness of Patient Decision Aids for Cancer-Related Decisions? A Systematic Review Subanalysis. McAlpine, K., Lewis, KB., Trevena, LJ., et al.[2019]

Patient decision aids help individuals make informed healthcare choices by incorporating their personal values and preferences, promoting a shared decision-making process between patients and healthcare providers.

These aids have been shown to improve discussions about treatment options, making them relevant for various common healthcare decisions, and they have demonstrated efficacy in enhancing patient engagement in their own care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An introduction to patient decision aids. [2012]

Decision aids significantly improve patients' knowledge and accuracy of risk perceptions, leading to more informed and values-congruent choices in treatment or screening decisions, based on a systematic review of 105 studies involving over 31,000 participants.

Patients using decision aids reported lower decisional conflict and were more actively involved in their decision-making process, with no adverse effects on health outcomes or satisfaction compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision aids for people facing health treatment or screening decisions. Stacey, D., Légaré, F., Lewis, K., et al.[2023]

A decision aid designed for discussions about smoking behavior before and after elective surgery significantly improved patient involvement and decisional quality in a study of 130 smokers, as measured by the Decisional Conflict Scale and Observing Patient involvement In decisiON-making scale.

Despite enhancing decision-making quality, the decision aid did not lead to any changes in actual smoking behavior or adherence to smoking cessation choices during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Aid for Cigarette Smokers Scheduled for Elective Surgery. Warner, DO., LeBlanc, A., Kadimpati, S., et al.[2018]

A project conducted at five primary care practices from 2010 to 2012 revealed that decision aids for colorectal cancer screening and back pain were distributed to only 9.3% and 10.7% of eligible patients, respectively, indicating a significant gap in their use despite their proven efficacy.

To improve the integration of decision aids into routine clinical care, the study suggests that substantial structural and cultural changes are needed, including ongoing incentives for use, enhanced physician training, and a team-based approach where all care team members are responsible for implementing these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An effort to spread decision aids in five California primary care practices yielded low distribution, highlighting hurdles. Lin, GA., Halley, M., Rendle, KA., et al.[2022]

About 69% of surveyed cancer physicians are aware of decision aids, but only 24% actively use them in practice, indicating a significant gap between awareness and implementation.

The main barriers to using decision aids include lack of awareness, resources, and time, highlighting the need for strategies to improve physician education and integration of these tools into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physicians' awareness and attitudes toward decision aids for patients with cancer. Brace, C., Schmocker, S., Huang, H., et al.[2015]

Decision aids in healthcare have been found to be feasible and acceptable to both patients and healthcare providers, enhancing the alignment between patients' values and their decisions, as well as improving their knowledge.

While decision aids can positively influence decision-making processes, their impact on patient outcomes such as decision uncertainty and satisfaction is generally modest, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effects of decision aids. Molenaar, S., Sprangers, MA., Postma-Schuit, FC., et al.[2017]

Health decision aids improve patient understanding of treatment options compared to standard care, facilitating better shared decision-making between patients and physicians.

While there is limited evidence on the best type of decision aid, more complex programs tend to have a greater impact on decision quality, suggesting potential for more informed patient choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health decision aids to facilitate shared decision making in office practice. Barry, MJ.[2022]

Decision aids have the potential to improve patient outcomes, but their use in clinical practice is still limited, indicating a need for better implementation strategies.

To enhance the effectiveness of decision aids, future research should focus on standardizing outcome measures, using mediation analysis to understand their impact, and clearly reporting trial results to identify the best conditions for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heading in a new direction? Recommendations for future research on patient decision aids. Herrmann, A., Hall, A., Zdenkowski, N., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06139354

NCT06139354 | Patient-provider Decision Aid for HIV Post ... The estimated cost of lifetime HIV treatment is $326,000,3 and HIV PEP is cost effective for high risk exposures. Each year approximately 300,000 people in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10592041/

Patient and provider decision making about HIV ... Observational studies have shown HIV PEP to be 99.5% effective when HIV risk-taking is minimized (Centers for Disease Control and Prevention, 2016; Otten et al.

3. reporter.nih.gov reporter.nih.gov/project-details/10886828

Development of a patient-provider decision aid for HIV post ... Improving HIV PEP implementation and understanding can improve care and outcomes for a highly marginalized group of people at risk for HIV. NIH Spending ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/01612840.2024.2366324

Readiness for HIV Postexposure Prophylaxis (PEP) ... Abstract. HIV post-exposure prophylaxis (PEP) can reduce the risk of acquiring HIV infection following sexual assault.

5. cdc.gov cdc.gov/mmwr/volumes/74/rr/rr7401a1.htm

Antiretroviral Postexposure Prophylaxis After Sexual .. ... This effective intervention uses antiretroviral (ARV) medications to reduce the likelihood of HIV acquisition after high-risk exposures. PEP can ...