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

NCT06159582 | Completed

• 1 other identifier: HS-2023-0226
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for racially/ethnically diverse transgender women (TW) and gay, bisexual, and other men who have sex with men (GBMSM) disproportionately impacted by the HIV epidemic. To reach this goal, the investigators will compare study outcomes among persons randomized to use a mobile app (eSTEP) intervention tailored to the unique needs of TW and GBMSM with interactive components delivered before in-person HIV testing and PrEP initiation visit and interactive components delivered after PrEP is initiated. The eSTEP group will be compared to usual HIV testing and PrEP care.

Conditions

Pre-Exposure Prophylaxis (PrEP)

Keywords

Pre-Exposure Prophylaxis (PrEP); HIV Prevention

Outcome Measures

Primary Outcomes (2)

• PrEP Initiation

  Percentage of study participants who initiate PrEP

  Within 24 weeks of enrollment

• Protective Levels of PrEP

  Percentage of participants who achieve protective levels of PrEP depending on the type of PrEP participants are taking: 1) if taking daily oral or 2-1-1 PrEP, protective level of PrEP is defined by drug level thresholds in the blood; 2) if taking injectable PrEP, protective level of PrEP is defined by timely (+/- 1 week for the second injection; +/- 2 weeks for any subsequent injection) administration.

  Throughout the 24 weeks of study participation, starting after PrEP initiation

Secondary Outcomes (1)

• PrEP Persistence

  Throughout the 24 weeks of study participation, starting after PrEP initiation

Study Arms (2)

eSTEP Treatment Group

ACTIVE COMPARATOR

Treatment group participants will be given access to eSTEP (Electronic Support to Engage with PrEP), an mHealth intervention to promote engagement on the full PrEP care continuum tailored to the unique needs of transgender women (TW) and gay, bisexual, and other men who have sex with men (GBMSM), in addition to the usual HIV testing and PrEP clinical care.

Behavioral: eSTEP

Control Arm

PLACEBO COMPARATOR

Usual HIV testing and PrEP clinical care

Behavioral: Usual Care

Interventions

eSTEP BEHAVIORAL

eSTEP (Electronic Support to Engage with PrEP) is an mHealth intervention to promote engagement on the full PrEP care continuum and is tailored to the unique needs of GBMSM and TW. eSTEP is a mobile app (eSTEP) intervention with interactive components delivered before in-person HIV testing and PrEP initiation visit and interactive components delivered after PrEP is initiated.

eSTEP Treatment Group

Usual Care BEHAVIORAL

Usual HIV testing and PrEP clinical care

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Of 120 participants all assigned male at birth, 85 will identify as men who have sex with men, and 35 will identify as transfeminine (woman, transgender woman, or non-binary)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Assigned male sex at birth
• Current male \& GBMSM 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• San Diego State University: lead
• University of California, San Diego: collaborator

Study Sites (1)

San Diego State University - Department of Psychology

San Diego, California, 92120, United States

Location

Related Publications (19)

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  BACKGROUND

Study Officials

• Keith J Horvath, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Susan J Little, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2-arm RCT with 2:1 randomization to eSTEP treatment group or usual care control group

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: April 3, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)