eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for men who have sex with men (MSM) and transgender women (TW).
To reach this goal, the investigators will compare study outcomes among persons randomized to receive a mobile app (eSTEP) intervention tailored to the needs of MSM and TW plus usual PrEP care to a group of persons who only receive usual PrEP care.
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:
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:
Exclusion Criteria: