Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04509076 |
| Other study ID # |
HS-2019-0291 |
| Secondary ID |
R34MH116878 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
April 15, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
San Diego State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The long-term goal of this research is to create an effective and sustainable program to
support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with
men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored
to young MSM, called PrEP iT! Primary aims include:
Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and
refine iterations through input from a community advisory board (CAB).
Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability
and preliminary impact of the PrEP iT! intervention for young MSM.
Description:
Study Design:
We propose to evaluate the feasibility, acceptability and preliminary impact of PrEP iT! in a
pilot RCT (n=80). Young men who have sex with men (YMSM) recently (re)initiating PrEP will be
randomized to receive either PrEP iT! plus usual care or usual care alone, and followed for 6
months with assessments at baseline, and 3- and 6-months.
PrEP iT! will use open source software that conforms to current programming standards, and
can be used across all devices (desktop, laptop, smartphone, and tablet) to ensure
sustainability. PrEP iT! will be developed from feedback from PrEP-using YMSM through focus
groups and a community advisory board (CAB). PrEP iT! is grounded in the Information,
Motivation, and Behavioral Skills model, and also draws from a model of technology adoption.
PrEP iT! intervention components are:
- PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
- Tailored feedback on PrEP adherence/non-adherence
- PrEP and sexual health information tailored for YMSM
- Text message reminders for PrEP adherence and healthcare appointments
- An "ask the expert" feature
Control arm participants will receive usual PrEP care only. Locally this entails, clinic
visits every 3 months in the initial period following PrEP initiation, including HIV/STI
screening and laboratory toxicity testing.
Study Sample:
Recruitment will be stratified by age in a 1:1 ratio (i.e., n=40 per group) of 18-24 and
25-29 year olds, and will reflect 50% Black and/or Hispanic YMSM participation. This will
allow us to explore subgroup differences (e.g., by age and race/ethnicity) for PrEP iT! to
better inform future trials.
Recruitment and Clinical Sites:
Participants will be recruited from two clinics in Minneapolis that provide PrEP care. The
clinical sites include the HIV clinic at Hennepin Healthcare (HH) and the Hennepin County STD
clinic. We will recruit and enroll study participants concurrent with their PrEP clinical
visits when possible.
Participants will be recruited in four ways: a) PrEP clinic patients who are new or returning
to care (i.e., are not currently receiving PrEP) will be identified by clinic staff and
referred to research coordinators on the day of their clinic visit when possible; b) flyers
will be hung in PrEP clinics and other HIV/AIDS NGO service organizations within the Twin
Cities; and c) the study team will engage and solicit referrals from other community HIV/AIDS
NGO with focused PrEP and prevention campaigns.
Enrollment, Randomization, and Follow-up Visits:
Study candidates will undergo a separate screening visit with a brief questionnaire at/after
PrEP clinic visits. Participants will have a rapid HIV test as part of usual care. Persons
whose test positive for HIV will be referred for same-day evaluation and care. Participants
are randomized 1:1 to either the intervention (PrEP iT! + usual care) or control (usual care)
arm. The randomization sequence will be stratified by age (18-24 v. 25-29 yrs) and use blocks
of ten.
After informed consent, participants will complete a computer-assisted baseline survey. All
participants will be provided usual PrEP educational information encouraged to attend their
regular healthcare visits. Participants randomized to the treatment arm (PrEP iT! + usual
care) will be guided through setting up their user account and user profile, provided with
basic training on how to navigate and use intervention components, and given the opportunity
to ask questions. YMSM in the treatment arm will have immediate access to PrEP iT! after the
initial visit.
YMSM will undergo a 3- and 6-month follow-up assessment, with multiple reminders sent to
participants prior to each visit. The 3- and 6-month stud procedures include completing a
short computerized assessment, and submitting a dried blood spot specimen for the TFV-DP
analyses. Study data will also be collected from the month 3 and month 6 healthcare visits
that include laboratory and clinical data generated routinely as part of standard PrEP care
(e.g., testing for HIV Ab and other STIs). We anticipate that most HIV tests results data
will be extracted from participant's medical record to confirm their HIV-negative status. In
the event that we must conduct an HIV test (e.g., we are unable to extract that from the
medical record or if there is an expressed concern that the participant's HIV status has
changed), they will be conducted at the Hennepin Healthcare clinical laboratory, using
standard clinical assays (we use the HIV Ab/Ag combination test for diagnosis). This
information would be captured in our CRFs via REDCap, and this information will be securely
transferred to SDSU but would be via a de-identified file.
Study retention protocols involve the use of multiple contact methods, including telephone
calls, text messages and e-mail reminders. We anticipate no more than 20% attrition.
Exit Interviews: A random subset of participants randomized to the PrEP iT! arm will be asked
if he would be willing to participate in 30-60 minute exit interview to assess a) his
experience in the intervention, b) suggestions for modifications to the existing interface,
c) suggestions for new features; and d) and changes to the study procedures. Recruitment for
exit interviews will entail sufficient numbers for the goal of achieving ten men completing
the exit interview.
