Patient-provider Decision Aid for HIV Post-exposure Prophylaxis Following Sexual Assault
NCT ID: NCT06139354
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
45 participants
INTERVENTIONAL
2024-10-04
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinic-based HIV Identification and Prevention Project Using Electronic Resources
NCT05412433
Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis Services for Cisgender Women
NCT07318532
HIV Prevention Preparedness Study
NCT00048282
Effectiveness and Implementation of Text Messaging to Improve HIV Testing in Adolescents
NCT06096519
OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
NCT03651453
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Davis
OTHER
District of Columbia Forensic Nurse Examiners
UNKNOWN
University of Arkansas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jocelyn Anderson
Role: PRINCIPAL_INVESTIGATOR
UAMS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
District of Columbia Forensic Nurse Examiners
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
276376
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.