eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Car… (NCT06159582) | Clinical Trial Compass
CompletedNot Applicable
eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
United States113 participantsStarted 2024-04-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PrEP Initiation
Timeframe: Assess throughout the 24 weeks after study enrollment.
2
Retention in PrEP Care at 12 Weeks
Timeframe: Participants who were retained in PrEP care through week 12 after enrollment
3
Retention in PrEP Care at 24 Weeks
Timeframe: Participants who were retained in PrEP care at week 24
4
Protective PreP Adherence at 12 Weeks
Timeframe: Assessed at 12 weeks after study enrollment
5
Protective PrEP Adherence at 24 Weeks
Timeframe: Assessed at 24 weeks after study enrollment