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

NCT06139354 | Recruiting

• 1 other identifier: 276376
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv

Keywords

sexual assault

Outcome Measures

Primary Outcomes (2)

• 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 (α) 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

• 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 (α) 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 Outcomes (4)

• HIV PEP acceptance

  immediately post-intervention

• HIV PEP completion

  one month follow up

• HIV PEP knowledge

  immediately post-intervention

• HIV PEP knowledge

  one month follow up

Study Arms (1)

decision aid

EXPERIMENTAL

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.

Behavioral: decision aid

Interventions

decision aid BEHAVIORAL

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.

decision aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[a) seeking care within 72 hours of potential exposure, b) potential exposure\]

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Arkansas: lead
• University of California, Davis: collaborator
• District of Columbia Forensic Nurse Examiners: collaborator

Study Sites (1)

District of Columbia Forensic Nurse Examiners

Washington D.C., District of Columbia, 20002, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jocelyn Anderson

  UAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Yu

CONTACT

(916) 360-0149; jcandresearch@uams.edu

Hannah Aston

CONTACT

jcandresearch@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: October 4, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)