Patient-provider Decision Aid for HIV Post-exposure Prophylaxis Following Sexual Assault

Hiv Clinical Trial

Official title:

Pilot Testing of a Patient-provider Decision Aid for HIV Post-exposure Prophylaxis Following Sexual Assault

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139354
• Other study ID #: 276376
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University of Arkansas
• Contact: Cecilia Sanchez
• Phone: (916) 360-0149
• Email: uamsucdavisresearch[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this trial is to pilot 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 multimedia-based 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.

Description:

HIV post-exposure prophylaxis (PEP) decision-making following nonoccupational exposures (e.g. sexual assault, intravenous drug use (IVDU), consensual condomless sex) is a complicated clinical dilemma for patients and providers. HIV PEP is a highly effective course of antiretroviral medications taken for 28 days after an exposure. 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 the US are sexually assaulted. For those who present for acute medical care following sexual assault, discussing HIV PEP is recommended by the International Association of Forensic Nurses (IAFN), Association of Nurses in AIDS Care, World Health Organization (WHO), and Department of Justice (DOJ).8-10 Despite its efficacy and these recommendations, HIV PEP remains inconsistently offered and initiated in sexual assault patient population.

Patient's must decide to take HIV PEP within 72 hours of an exposure. HIV PEP is not effective when initiated more than 72 hours after a potential exposure. These are not ideal conditions for making complex decisions. Patients report discussions regarding potential HIV exposure following sexual assault can cause an emotional response and asked providers to "do more" regarding explaining the realities of daily HIV PEP. Patients in the investigators' prior and ongoing work described inconsistent provider communication on the need for HIV PEP and lack of clarity regarding HIV risk as main barriers to decision making.

Provider HIV PEP provision patterns indicate important inequities in post-sexual assault HIV PEP patient care. The Centers for Disease Control and Prevention (CDC) guidelines include recommendations for HIV PEP following a non-occupational exposure, however there is a large gray area: decisions should be made on a "case-by-case" basis when the HIV status of the source is unknown. This translates into variations in clinical practice. Studies examining providers' behavior in offering HIV PEP to patients following sexual assault indicate they are influenced by factors such as pre-existing relationship between patient and the perpetrator, patient age, patient and perpetrator race, and anticipated patient financial burden. Additionally, in a survey previously conducted by the investigators, Sexual Assault Nurse Examiner (SANE) program coordinators reported a perception that patients "don't, won't, or can't follow-up" as a key reason for not offering HIV PEP routinely.

While not examined in HIV PEP, decision aids facilitate patient-provider communication and decision making. A 2017 Cochrane review of decision aids found patients who used a decision aid felt more informed about their decision and reported less decisional conflict. Patient-provider communication also improved.

Therefore, the goal of this pilot test 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 multimedia-based 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• seeking care from DCFNE following sexual assault

• able to provide consent and participate in the study in English

• meets CDC criteria for HIV PEP [a) seeking care within 72 hours of potential exposure, b) potential exposure]

Exclusion Criteria:

• <18 years old

• Does not meet CDC criteria for HIV PEP [seeking care >72 hours after assault, assault with minimal/low exposure risk]

• unable to complete study requirements in English

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• decision aid
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	District of Columbia Forensic Nurse Examiners, University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decisional conflict	Modified questions from the Decisional Conflict Scale (O'Connor, 1993; 2010) as a measure of decision process. This scale tests whether using the HIV PEP decision aid helps a patient understand their options. This measure has a test-retest reliability from 0.75 to 0.81 and internal consistency (a) ranging from 0.72 to 0.92. The psychometric properties have been evaluated for the low literacy English version.; Scores range from 0 [no decisional conflict] to 100 [very high decisional conflict].	immediately post-intervention
Primary	decisional conflict	Modified questions from the Decisional Conflict Scale (O'Connor, 1993; 2010) as a measure of decision process. This scale tests whether using the HIV PEP decision aid helps a patient understand their options. This measure has a test-retest reliability from 0.75 to 0.81 and internal consistency (a) ranging from 0.72 to 0.92. The psychometric properties have been evaluated for the low literacy English version.; Scores range from 0 [no decisional conflict] to 100 [very high decisional conflict].	one month follow up
Secondary	HIV PEP acceptance	yes or no - patient decision to take or not take HIV PEP	immediately post-intervention
Secondary	HIV PEP completion	Number of days (0-28) of HIV PEP patient completed	one month follow up
Secondary	HIV PEP knowledge	Summary score from 6 items such as: "Within how long after an HIV exposure should PEP be started to prevent HIV?" & "How long do you take PEP?". Scores range from 0 to 6 based on the number of correct answers. Higher scores indicate more knowledge of HIV PEP. Items from Koblin et al. 2018.	immediately post-intervention
Secondary	HIV PEP knowledge	Summary score from 6 items such as: "Within how long after an HIV exposure should PEP be started to prevent HIV?" & "How long do you take PEP?". Scores range from 0 to 6 based on the number of correct answers. Higher scores indicate more knowledge of HIV PEP. Items from Koblin et al. 2018.	one month follow up