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Pre-exposure ProphylaxisNCT05728034

Information Seeking About Pre-exposure Prophylaxis

A study testing Injectable PrEP information and Oral PrEP information in people with Pre-exposure Prophylaxis, run by Penn State University 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 these two intervention studies is to test promising health communication messaging strategies most likely to enhance Black, Hispanic, and non-Hispanic White YMSM's (young men who have sex with men's) engagement with online content about injectable and oral PrEP (pre-exposure prophylaxis). Read more about this study

Who is it for?
Ages 18 to 34 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pre-exposure Prophylaxis
What is being tested?
Injectable PrEP information and Oral PrEP information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteUnited States
Study dates
30 May 2023to 18 Aug 2025
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 to 34 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have an Internet-connectable device (Study 1 only)
  • Be 18-34 years of age
  • Identify as cisgender male
  • Identify as gay or bisexual
  • Be HIV negative
  • Have had anal sex in the past 6 months
  • Meet one of the following criteria: a. Have a sexual partner with HIV, b. Have inconsistent condom use, c. Have received an STI diagnosis in the last 6 months.

Who cannot join

  • Does not meet all of the criteria above

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pennsylvania State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: Information Seeking About Pre-exposure Prophylaxis Among Men Who Have Sex With Men

The goal of these two intervention studies is to test promising health communication messaging strategies most likely to enhance Black, Hispanic, and non-Hispanic White YMSM's (young men who have sex with men's) engagement with online content about injectable and oral PrEP (pre-exposure prophylaxis). Participants will be asked to browse a mock Google results page featuring various kinds of PrEP information, and their browsing behavior will be unobtrusively logged. In Study 1, participants will be randomly assigned to browse for information about oral PrEP or browse for information about injectable PrEP. The design of Study 2 will be identical to Study 1 but will focus only on injectable PrEP content. In addition to browsing behavior, visual behavior data will also be collected in Study 2 with eye-trackers.

Read the detailed description

Study 1 (online between-subjects experiment): An online sample of YMSM (N = 600) will be strategically recruited to partake in a web-based survey experiment following a mixed experimental design: 2 (PrEP type [between]: oral or injectable PrEP) X 5 (messaging strategy [within]: response efficacy, social norms, exemplar, celebrity, \& basic information). The survey will begin by determining eligibility (self-report screener questions), gathering consent, and asking participants to self-report on several psychographic measures (PrEP awareness, knowledge, interest, and stigma). Participants will then be asked to interact with a mock Google results page featuring an array of information about PrEP. The survey will randomly assign participants to one of two versions of the mock Google search page: Half of participants (n = 300) will browse for information about oral PrEP, and the other half (n = 300) will browse for information about injectable PrEP. This browsing experience will unobtrusively log browsing data (clicks, page durations). Participants will be able to click on the links on the search results page (which reflect the five messaging strategies), visit those pages, and return to the main results page. After three minutes, participants will then be asked to self-report their intention to adopt PrEP. They will then be debriefed.

Study 2 (in-person within-subjects experiment): Interested participants will complete an initial screening questionnaire to ensure eligibility and then be linked to a separate survey to provide their contact information. Upon arrival to the study site, participants (N = 75) will begin by providing consent. They will then complete the same measures as Study 1 of PrEP interest, knowledge, and stigma. A research assistant will lead participants through a calibration activity to ensure the eye-trackers are able to track the participants' eye gaze. Participants will complete the same mock browsing experience as Study 1 with the exception that all participants will browse for information about injectable PrEP. The survey software will unobtrusively log browsing behavior (clicks, page durations) while eye-trackers will unobtrusively track visual behavior (fixations). Participants will then self-report their intent to use PrEP and be debriefed by a research assistant,

Being tested
Injectable PrEP information, Oral PrEP information

What participants receive

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

  • Injectable PrEP informationBehavioural

    Participants will be able to click on the links on the search results page (which reflect the five messaging strategies about injectable PrEP), visit those pages, and return to the main results page.

  • Oral PrEP informationBehavioural

    Participants will be able to click on the links on the search results page (which reflect the five messaging strategies about oral PrEP), visit those pages, and return to the main results page.

Study groups in NCT05728034
Study groupRoleWhat they receive
Injectable PrEP informationExperimentalA mock Google search results page with five search results that reflect five messaging strategies about injectable PrEP (response efficacy, social norms, exemplar, celebrity, and basic information), displayed in random order.
Receives: Behavioral: Injectable PrEP information
Oral PrEP information (Study 1 only)ExperimentalA mock Google search results page with five search results that reflect five messaging strategies about oral PrEP (response efficacy, social norms, exemplar, celebrity, and basic information), displayed in random order.
Receives: Behavioral: Oral PrEP information

What is being measured

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

  1. Browsing behavior - First click

    SoSciSurvey software will unobtrusively log the clicks participants will make on the different search results, with each search result reflecting a different messaging strategy (response efficacy, social norms, exemplar, celebrity, and basic information). Our analysis will focus on which search result/messaging strategy participants click on first as a behavioral indicator of message engagement.

    Measured: Recorded while participants complete the Google results browsing task (3 minutes max)

  2. Browsing behavior - Total page duration

    SoSciSurvey software will unobtrusively log the amount of time (in seconds) participants spend on the different search results after clicking on it, with each search result reflecting a different messaging strategy (response efficacy, social norms, exemplar, celebrity, and basic information). Our analysis will focus on the total amount of time participants spend on the page for each of the different search results/messaging strategies as a behavioral indicator of message engagement.

    Measured: Recorded while participants complete the Google results browsing task (3 minutes max)

  3. Visual behavior - Total fixation duration (Study 2 only)

    Total fixation duration can be defined as how long the eyes dwell on a particular object in one's field of vision. Total fixation duration will be recorded by mobile eye-trackers.

    Measured: Recorded while participants complete the Google results browsing task (3 minutes max)

Secondary outcomes (2)
  1. Change in intention to adopt PrEP

    Self-reported change in intention to initiate PrEP, assessed on a 0-100 sliding scale (0 = definitely not, 100 = definitely yes). Thus, higher scores reflect greater intentions to use PrEP.

    Measured: Will be measured immediately after completing the browsing task

  2. Open-ended responses

    Participants will be given an opportunity to list any other thoughts and suggestions they have about the kinds of messaging strategies about injectable PrEP that might engage their attention.

    Measured: Will be measured immediately after completing the browsing task

Timeline

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

  1. First posted14 Feb 2023
  2. Study start30 May 2023
  3. Primary completion18 Aug 2025
  4. Study completion18 Aug 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05728034
Sponsor's protocol ID
STUDY00021859
Status last verified
Feb 2026
First submitted
3 Feb 2023
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The researchers will make all data, analysis syntax, and materials (e.g., stimuli, survey measures) publicly available in accordance with NIH data sharing policies as well as Penn State University's IRB guidelines. Quantitative data will be made available in a non-proprietary file format (e.g., CSV). The researchers will strip all data of any personally identifying information before sharing our data. All the collected data will be actively managed, redundantly archived, and ultimately shared with the broader scientific community by the Data Commons online repository. The Penn State Data Commons is a service administered by Penn State University that provides maintenance and open access sharing of research project data during and after the period of support for the project. The Data Commons was developed with the intent of helping researchers comply with grant-funding agency requirements. It supports dissemination and long-term preservation (management, use, and re-use) of data.

Questions about this trial

What is this clinical trial studying?

A study testing Injectable PrEP information and Oral PrEP information in people with Pre-exposure Prophylaxis, run by Penn State University 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 7 inclusion and 1 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 9 Feb 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?

Browsing behavior - First click (time frame: Recorded while participants complete the Google results browsing task (3 minutes max)). The study lists 3 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 9 Feb 2026.

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