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

NCT06159582 | Completed Results

• 1 other identifier: HS-2023-0226
• Study Type: interventional
• Target: 113
• 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 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.

Conditions

Pre-Exposure Prophylaxis (PrEP)

Keywords

Pre-Exposure Prophylaxis (PrEP); HIV Prevention

Outcome Measures

Primary Outcomes (5)

• PrEP Initiation

  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

  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

  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

  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

  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

Study Arms (2)

eSTEP Arm

ACTIVE COMPARATOR

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; Behavioral: Usual Care

Control Arm

PLACEBO COMPARATOR

Usual 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 MSM and TW.

eSTEP Arm

Usual Care BEHAVIORAL

Usual PrEP clinical care

Control Arm; eSTEP Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Of the 113 participants, 24 identified as a TW.
• 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 \& 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

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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  PMID: 31965523 BACKGROUND

• John SA, Whitfield THF, Rendina HJ, Parsons JT, Grov C. Will Gay and Bisexual Men Taking Oral Pre-exposure Prophylaxis (PrEP) Switch to Long-Acting Injectable PrEP Should It Become Available? AIDS Behav. 2018 Apr;22(4):1184-1189. doi: 10.1007/s10461-017-1907-2.

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  BACKGROUND

Results Point of Contact

• Title: Dr. Keith Horvath
• Organization: San Diego State University

khorvath@sdsu.edu

6196943346

Study Officials

• Keith J Horvath, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Susan J Little, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 23, 2026
• Results First Posted: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)