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Behavioral Intervention

eSTEP Treatment Group for Pre-Exposure Prophylaxis (eSTEP Trial)

N/A

Recruiting

Led By Keith J Horvath, PhD

Research Sponsored by San Diego State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 weeks of enrollment

Awards & highlights

eSTEP Trial Summary

This trial aims to develop a mobile health intervention for transgender women and men who have sex with men, who are disproportionately affected by HIV. The intervention will include a mobile app with interactive components to be used

Who is the study for?

This trial is for English-speaking transgender women and gay/bisexual men over 18 who are HIV-negative, own a smartphone, and have not used PrEP in the past 3 months. They must be eligible for PrEP per CDC guidelines, which includes having an HIV-positive partner or a recent STI.Check my eligibility

What is being tested?

The eSTEP study tests a mobile app designed to help at-risk individuals start and stick with Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Participants will either use this new app along with their usual care or just receive the usual care without the app.See study design

What are the potential side effects?

Since this trial involves using an mHealth intervention rather than medication, traditional side effects are not expected. However, participants may experience issues related to technology use such as privacy concerns or stress from regular notifications.

eSTEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 weeks of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 weeks of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 weeks of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PrEP Initiation

Protective Levels of PrEP

Secondary outcome measures

PrEP Persistence

eSTEP Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: eSTEP Treatment GroupActive Control1 Intervention

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.

Group II: Control ArmPlacebo Group1 Intervention

Usual HIV testing and PrEP clinical care

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor

154 Previous Clinical Trials

116,008 Total Patients Enrolled

University of California, San DiegoOTHER

1,126 Previous Clinical Trials

1,552,871 Total Patients Enrolled

Keith J Horvath, PhDPrincipal InvestigatorSan Diego State University

1 Previous Clinical Trials

254 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this research study?

"Indeed, the details on clinicaltrials.gov indicate that this medical research is actively seeking participants. The trial was first listed on April 3rd, 2024, and its most recent update was on April 9th, 2024. There is a need for 120 patients at a single designated site."

Answered by AI

Is this clinical trial currently accepting new participants?

"As per clinicaltrials.gov, this ongoing medical investigation is actively seeking participants. The trial was initially listed on April 3rd, 2024 and most recently updated on April 9th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Keith Horvath 2024. "eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159582.