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

May 27, 2026 updated by: Keith Horvath, San Diego State University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego State University - Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: eSTEP Arm
Treatment group participants will be given access to the eSTEP (Electronic Support to Engage with PrEP) mobile app to promote engagement on the full PrEP care continuum plus usual PrEP clinical care. eSTEP 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) section.
Behavioral: eSTEP
eSTEP (Electronic Support to Engage with PrEP) is an mHealth intervention to promote engagement on the full PrEP care continuum and is tailored to MSM and TW.
Behavioral: Usual Care
Usual PrEP clinical care
Placebo Comparator: Control Arm
Usual PrEP clinical care
Behavioral: Usual Care
Usual PrEP clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Initiation
Time Frame: Assess throughout the 24 weeks after study enrollment.
PrEP initiation was the percent of participants in each arm who started PrEP any time in the 24 weeks after enrollment. A participant was considered to have initiated if they had evidence in the medical record of starting PrEP at any point during the 6-month intervention period. Study staff performed a review of medical records, including clinical encounters and medication records to confirm PrEP initiation.
Assess throughout the 24 weeks after study enrollment.
Retention in PrEP Care at 12 Weeks
Time Frame: Participants who were retained in PrEP care through week 12 after enrollment
Retention in PrEP care was assessed at 12 weeks based on documentation in the medical record during follow-up or clinical encounters. Participants were considered retained in care if they had initiated PrEP at the prior study visit and the clinician documented ongoing PrEP use during a follow-up clinical encounter or if there was evidence that the participant initiated a refill request in the absence of a visit as of the next study visit. At 12 weeks, participants were recorded as being retained in PrEP care (1) or not (0).
Participants who were retained in PrEP care through week 12 after enrollment
Retention in PrEP Care at 24 Weeks
Time Frame: Participants who were retained in PrEP care at week 24
Retention in PrEP care was assessed at 24 weeks based on documentation in the medical record during follow-up or clinical encounters. Participants were considered retained in care if they had initiated PrEP at the prior study visit and the clinician documented ongoing PrEP use during a follow-up clinical encounter or if there was evidence that the participant initiated a refill request in the absence of a visit as of the next study visit. At 24 weeks, participants were recorded as being retained in PrEP care (1) or not (0).
Participants who were retained in PrEP care at week 24
Protective PreP Adherence at 12 Weeks
Time Frame: Assessed at 12 weeks after study enrollment
Protective PrEP adherence for oral PrEP was assessed through analysis of TFV-DP levels from DBS specimens obtained using self-collection kits. Tenofovir diphosphate (TFV-DP) levels were categorized as either protective (corresponding with ≥4 doses per week) or not protected (≤3 doses per week). For participants on injectable PrEP, timely PrEP injections (receiving an injection within 2 weeks of the ideal injection date) was used to determine whether they were protected or not protected.
Assessed at 12 weeks after study enrollment
Protective PrEP Adherence at 24 Weeks
Time Frame: Assessed at 24 weeks after study enrollment
Protective PrEP adherence for oral PrEP was assessed through analysis of TFV-DP levels from DBS specimens obtained using self-collection kits. Tenofovir diphosphate (TFV-DP) levels were categorized as either protective (corresponding with ≥4 doses per week) or not protected (≤3 doses per week). For participants on injectable PrEP, timely PrEP injections (receiving an injection within 2 weeks of the ideal injection date) was used to determine whether they were protected or not protected.
Assessed at 24 weeks after study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Persistence
Time Frame: Throughout the 24 weeks of study participation, starting after PrEP initiation
Percentage of participants who achieve PrEP persistence defined as: 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of CAB-LA and 2) has an active prescription for PrEP based on study records.
Throughout the 24 weeks of study participation, starting after PrEP initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Keith J Horvath, PhD, San Diego State University
  • Principal Investigator: Susan J Little, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-2023-0226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will share summary statistics, aggregated data. No deidentified data will be publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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