Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05395754 |
| Other study ID # |
2268 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Louisiana State University Health Sciences Center in New Orleans |
| Contact |
Meredith Clement, MD |
| Phone |
252-902-4961 |
| Email |
mclem5[@]lsuhsc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study will recruit 120 Black men who have sex with men (BMSM) from the local area, New
Orleans. The main purpose of this research study is to test the effect of a new smartphone
application, "PCheck," on reducing the incidence of STIs, compared to routine care through
the LSU-Crescent Care Sexual Health/PrEP Clinic.
Description:
This unblinded, randomized study will determine the feasibility and preliminary impact of our
adapted PCheck app in reducing STI infections in Black MSM PrEP users. Over 12 months, the
research staff will prospectively enroll BMSM entering or already engaged in PrEP care.
Participants will be randomly allocated 2:1 to the PCheck intervention versus standard of
care using an automated system for randomization; the rationale for heavier allocation to the
intervention is to allow for more participants to interact on the app (colleagues at the
University of Virginia who have tested a similar app advised that a "critical mass" of
roughly 20 participants using the community forum is needed for discussions to begin
organically).15 Randomization will occur upon first meeting with the clinical research
coordinator (CRC).
At enrollment, those randomized to the intervention arm will receive hands-on app onboarding
training by the CRC. The training is anticipated to take 15-30 minutes and will include an
overview of the app's features and how to use each, coaching about using the daily check-in
feature to record mood, stress levels, and recent sexual activity and condom use, guidance on
creating an anonymous introductory post to the community board, and practice using each of
the PCheck features. Participants allocated to the intervention arm will receive the
intervention (use of the PCheck app) for 12 months of follow-up. Participants will be
encouraged to use the app as much as they wish throughout the study and will be informed that
there will be no set expectation for how frequently they must use the app, although they will
be encouraged to use it regularly to "thoroughly test it". The app will send notification
reminders to "check in" (in other words, use the daily check-in feature to track their mood,
stress, and behaviors related to STI-prevention over time). The notification settings can be
adjusted in phone settings by the participant.
For participants receiving the app intervention, study staff will also schedule a follow-up
call within two weeks after enrollment to encourage engagement, to talk through any
difficulties that arise with using the app and to troubleshoot. During the 12 months of
enrollment, study staff will contact participants at the 1, 2, 4, and 12 week marks after
they stop showing usage on the app to encourage re-engagement and address any technical or
other barriers.
To encourage engagement with the app, the research team will post short quizzes on the app's
landing page and reminders about them on the community message board. The study will pilot
once-a-day trivia questions, and adjust the frequency of trivia postings pending on
participant engagement and/or feedback. Each set of trivia questions will take a couple
minutes to complete and will ask 1-2 questions such as general knowledge about STIs, sexual
health and wellness, and/or general New Orleans-specific or LGBTQI+ history. All participants
who complete 100% of the quizzes for the week will be entered into a raffle for an additional
$10 loaded onto their Clincard.
For app users, data will be extracted directly from the PCheck app, including app usage and
data from the app's check-in, PrEP adherence, and STI prevention features. App data will be
de-identified except for anonymous username and study ID number, which can be linked to
identifying information in order to contact individuals not showing usage on the app, as
described above.
For all participants, STI (syphilis, gonorrhea, chlamydia, HIV) screening will occur every
three months and HCV screening every 6-12 months over 12 months of follow-up as part of
routine care. Every three months, all participants will also complete self-administered
questionnaires with demographic, social, and behavioral assessments. Participants allocated
to the standard of care control group will be informed that their participation entails
attending routine PrEP appointments, including STI screening, and completing the quarterly
surveys. For those in the intervention arm, participants will also answer questions aimed at
assessing app acceptability, feasibility, and usability.
