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HivNCT06139354

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

A study testing decision aid in people with Hiv, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hiv
What is being tested?
decision aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
4 Oct 2024to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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]

Who cannot join

  • <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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • District of Columbia Forensic Nurse Examiners

    Washington D.C., District of Columbia, 20002

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Hiv
Being tested
decision aid
Keywords
sexual assault
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • decision aidBehavioural

    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.

Study groups in NCT06139354
Study groupRoleWhat they receive
decision aidExperimentalA 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.
Receives: Behavioral: decision aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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].

    Measured: immediately post-intervention

  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].

    Measured: one month follow up

Secondary outcomes (4)
  1. HIV PEP acceptance

    yes or no - patient decision to take or not take HIV PEP

    Measured: immediately post-intervention

  2. HIV PEP completion

    Number of days (0-28) of HIV PEP patient completed

    Measured: one month follow up

  3. 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.

    Measured: immediately post-intervention

  4. 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.

    Measured: one month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start4 Oct 2024
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139354
Sponsor's protocol ID
276376
Status last verified
Jul 2026
First submitted
14 Nov 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing decision aid in people with Hiv, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

decisional conflict (time frame: immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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