eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum

Study Design:

The investigators propose to evaluate the feasibility, acceptability, and preliminary impact of eSTEP in a pilot RCT with MSM and TW 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 to increase PrEP uptake, and components to optimize PrEP retention and adherence.

eSTEP is grounded in the Information, Motivation, Behavioral Skills model [IMB] and includes the following components:

• PrEP information
• Identifying and addressing barriers to starting PrEP
• Information about stigma and managing stigma
• Matching the best PrEP option to one's personal life circumstances
• Appointment Scheduling
• PrEP Adherence Reminders & Self-monitoring for those who start PrEP
• PrEP Appointment Reminders
• A Frequently Asked Question (FAQ) Control arm participants will not be offered the eSTEP mobile app, but both the eSTEP arm and control arm will be asked to attend a brief telephone visit with a PrEP navigator, which is usual care for the clinic.

Study Sample:

113 adult (18 years and older) MSM (n=89) and TW (n=24) participants (n = 89 MSM; n = 24 TW) not currently taking PrEP.

Recruitment and Clinical Sites:

Participants will be recruited in the following ways: a) ads on social media sites 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.

Enrollment, Randomization and Follow-up Visits:

Study candidates completed a short online pre-screening survey to assess eligibility. Next, preliminarily eligible participants completed a virtual enrollment visit to verify eligibility and complete an electronic written consent. After informed consent, participants completed an online 30- to 45-minute baseline survey. Participants were then randomized 2:1 either to the intervention arm (eSTEP and usual care) or to the control arm (Usual care only). All participants were provided with community resources electronically by the study coordinator and asked to schedule a telephone-based informational meeting with a clinic PrEP navigator. Persons who wish to start PrEP were scheduled for 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 who received a positive test for HIV during the trial received appropriate post-test counseling and treatment by the HIV treatment and prevention clinic staff. Participants were asked to provide 3 self-collected dried blood spots (DBS) for the TFV-DP analysis (i.e., to assess PrEP adherence). All participants completed online surveys and DBS at weeks 12 and 24, and medical records were reviewed to determine PrEP initiation, retention in PrEP care, and timely PrEP injections.

Inclusion criteria

• 18 years of age or older
• Assigned male sex at birth
• Current male & MSM identity OR transfeminine (woman, transgender woman, or non-binary) identification
• Self-reported HIV-negative status
• English-speaking (since the pilot intervention will be developed in English)
• Owner of an Android or iPhone mobile device and access to this phone during the 6-month study.
• Willingness and ability to attend HIV prevention visits at the HIV treatment and prevention clinic.
• Consent to allow study team access to study-relevant PHI
• Eligible for PrEP following CDC guidelines (in the past 6 months had a sexual partner with HIV with unknown or detectable viral load, inconsistently used condoms, and/or was diagnosed with a sexually transmitted infection)
• Has never used PrEP or has not used PrEP in the past 3 months

Exclusion criteria

• Was a Community Advisory Board Member or participant in the eSTEP focus groups
• Assigned female or intersex at birth
• Living with HIV
• Already taking PrEP
• Under 18 years old
• Does not own a mobile phone
• Does not speak or read English (since the pilot intervention will be developed in English)