Clinical trial NCT05728034: Information Seeking About Pre-exposure Prophylaxis
Official title: Information Seeking About Pre-exposure Prophylaxis Among Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre-exposure Prophylaxis
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 675
Sex: MALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.

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,

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Does not meet all of the criteria above

Primary outcomes:
measure: Browsing behavior - First click
timeFrame: Recorded while participants complete the Google results browsing task (3 minutes max)
measure: Browsing behavior - Total page duration
timeFrame: Recorded while participants complete the Google results browsing task (3 minutes max)
measure: Visual behavior - Total fixation duration (Study 2 only)
timeFrame: Recorded while participants complete the Google results browsing task (3 minutes max)
Secondary outcomes:
measure: Change in intention to adopt PrEP
timeFrame: Will be measured immediately after completing the browsing task
measure: Open-ended responses
timeFrame: Will be measured immediately after completing the browsing task
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Christofer J Skurka, PhD
role: PRINCIPAL_INVESTIGATOR
References: