Study Design:
The investigators propose to evaluate the feasibility, acceptability, and preliminary
impact of eSTEP in a pilot RCT with transgender women (TW) and gay, bisexual, and other
men who have sex with men (GBMSM) who are either PrEP naïve or have not been taking PrEP
for at least 3 months, randomized (2:1) to receive either the eSTEP intervention or usual
PrEP prevention services, and followed for 6 months with assessments at baseline, 12- and
24-weeks. eSTEP is a mobile application (i.e., app) with interactive PrEP components
delivered before in-person HIV testing (at a university-based HIV treatment and
prevention clinic) to increase PrEP uptake, and components to optimize PrEP adherence and
persistence delivered after the participant tests negative for HIV and agrees to start
PrEP. eSTEP will be tailored to the unique needs of TW and GBMSM to optimize its impact
and relevance for each group.
eSTEP is grounded in the Information, Motivation, Behavioral Skills model [IMB] and also
draws from a model of technology adoption. eSTEP intervention components are:
HIV Testing and PrEP Information
Identify and Addressing Barriers to PrEP Uptake and Stigma
PrEP Eligibility Survey and Preparing to Start PrEP
HIV Testing Visit Preparation
Appointment Scheduling
PrEP Adherence Reminders & Self-monitoring for those who start PrEP
Adherence Feedback
PrEP Appointment Reminders
PrEP and Risk Reduction Information Control arm participants will not be offered the
eSTEP mobile app and will receive information about how to schedule their HIV
testing appointment at the HIV treatment and prevention clinic on their own (which
is the standard procedure for the clinic). Community resources will be also provided
electronically to control and treatment arm participants.
Study Sample:
Recruitment will be 120 adult (18 years and older) GBMSM and TW participants (n = 85
GBMSM; n = 35 TW) and will reflect at least 50% Black and/or Latinx participants to
ensure that eSTEP is piloted among persons most at risk for HIV. This will allow the
investigators to explore differences (e.g. by geder, race and ethnicity) for eSTEP to
inform future trials.
Recruitment and Clinical Sites:
Participants will be recruited from a university-based HIV treatment and prevention
clinic, as well as in the local San Diego GBMSM and TW communities through the following
ways: a) ads on social media sites (e.g., Facebook/Instagram; Grindr) that will link to
an online pre-screening survey, b) in-person while attending an HIV testing appointment
at the HIV treatment and prevention clinic, c) community recruitment with our existing
GBMSM and TW Community Advisory Boards (CABs) and partner community organizations, d) via
a part-time recruiter (a peer recruiter or someone with experience in the community).
Enrollment, Randomization and Follow-up Visits:
Study candidates will complete a short online pre-screening survey to assess eligibility
on REDCap. Preliminarily eligible participants will complete the enrollment visit over
Zoom to verify eligibility and complete online written consent. After informed consent,
participants will complete an online 30- to 45-minute baseline survey. All participants
will be provided with community resources electronically by the study coordinator and
asked to schedule an in-person clinical appointment at the HIV treatment and prevention
clinic for routine HIV testing, eligibility and safety lab screening for PrEP as
routinely offered in the HIV treatment and prevention clinic. Any participant that
receives a positive test for HIV during the trial will receive appropriate post-test
counseling and treatment by the HIV treatment and prevention clinic staff. All
participants will also be provided 3-4 dried blood spot (DBS) testing kits to
self-collect their DBS specimen for the TFV-DP analysis (PrEP adherence) with a detailed
instruction sheet and link to a video demonstration of the DBS collect procedure. These
kits and the first DBS collection may take place either in person at the HIV treatment
and prevention clinic or if necessary, by mail.
Participants will be randomized 2:1 either to the intervention arm (eSTEP and usual care)
or to the control arm (HIV testing usual care) using the randomization feature in REDCap.
Participants randomized to the treatment arm (eSTEP and 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. Participants in the treatment arm will have immediate access to eSTEP as part
of the initial visit.
Participants will undergo an online 30-45-minute survey at week 12 and week 24. All
participants receiving either daily oral or on-demand (2-1-1) PrEP will be asked to
complete and submit a DBS specimen at week 12 and week 24 using the kits provided earlier
in person at HIV treatment and prevention clinic or by mail and will be seen in-person at
the HIV treatment and prevention clinic for usual PrEP care follow-up. Participant survey
data will be captured in Qualtrics and, along with clinical study data collected from HIV
treatment and prevention clinic HIV testing, and PrEP care appointments, will be captured
in our web-based case report forms (CRFs) using REDCap (Research Electronic Data Capture)
open software and securely transferred to SDSU via a deidentified file. For treatment arm
participants, survey data collection may occur on a mobile device that can access the
internet and will be housed on the San Diego State University server.
Study retention protocols involve the use of multiple contact methods including telephone
calls, text messages, e-mail reminders, social media, and contact information for a
friend/family member - and with permission for the use of each.
Exit Interviews:
10 GBMSM and 10 TW in the eSTEP intervention arm only will be purposively selected (high
eSTEP user vs. low user; diversity in race/ethnicity) for a 30-60-minute exit interview
to assess their experience in the intervention, suggestions for modifications to the
existing interface, suggestions for new features, and changes to any study procedures.