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Pre-Exposure Prophylaxis (PrEP)eSTEPNCT06159582

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

A study testing eSTEP in people with Pre-Exposure Prophylaxis (PrEP), run by San Diego State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Pre-Exposure Prophylaxis (PrEP)
What is being tested?
eSTEP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
1 siteUnited States
Study dates
3 Apr 2024to 30 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Diego State University - Department of Psychology

    San Diego, California, 92120

Other trials in United States

About this study

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.

Read the 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.

Being tested
eSTEP, Usual Care
Keywords
Pre-Exposure Prophylaxis (PrEP), HIV Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eSTEPBehavioural

    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.

  • Usual CareBehavioural

    Usual PrEP clinical care

Study groups in NCT06159582
Study groupRoleWhat they receive
eSTEP ArmActive comparatorTreatment 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.
Receives: Behavioral: eSTEP; Behavioral: Usual Care
Control ArmPlacebo comparatorUsual PrEP clinical care
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assess throughout the 24 weeks after study enrollment.

  2. 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).

    Measured: Participants who were retained in PrEP care through week 12 after enrollment

  3. 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).

    Measured: Participants who were retained in PrEP care at week 24

  4. 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.

    Measured: Assessed at 12 weeks after study enrollment

  5. 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.

    Measured: Assessed at 24 weeks after study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study start3 Apr 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-arm RCT with 2:1 randomization to eSTEP treatment group or usual care control group
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06159582
Sponsor's protocol ID
HS-2023-0226
Acronym
eSTEP
Status last verified
May 2026
First submitted
28 Nov 2023
Last updated
23 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will share summary statistics, aggregated data. No deidentified data will be publicly available.

Publications

  • Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.

    PubMed 27098408

  • Poteat T, Wirtz A, Malik M, Cooney E, Cannon C, Hardy WD, Arrington-Sanders R, Lujan M, Yamanis T. A Gap Between Willingness and Uptake: Findings From Mixed Methods Research on HIV Prevention Among Black and Latina Transgender Women. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):131-140. doi: 10.1097/QAI.0000000000002112.

    PubMed 31180995

  • Volk JE, Marcus JL, Phengrasamy T, Blechinger D, Nguyen DP, Follansbee S, Hare CB. No New HIV Infections With Increasing Use of HIV Preexposure Prophylaxis in a Clinical Practice Setting. Clin Infect Dis. 2015 Nov 15;61(10):1601-3. doi: 10.1093/cid/civ778. Epub 2015 Sep 1.

    PubMed 26334052

  • Murnane PM, Celum C, Mugo N, Campbell JD, Donnell D, Bukusi E, Mujugira A, Tappero J, Kahle EM, Thomas KK, Baeten JM; Partners PrEP Study Team. Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial. AIDS. 2013 Aug 24;27(13):2155-60. doi: 10.1097/QAD.0b013e3283629037.

    PubMed 24384592

  • Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

    PubMed 21091279

  • Camp C, Saberi P. Facilitators and barriers of 2-1-1 HIV pre-exposure prophylaxis. PLoS One. 2021 May 20;16(5):e0251917. doi: 10.1371/journal.pone.0251917. eCollection 2021.

    PubMed 34014998

  • Sewell WC, Powell VE, Mayer KH, Ochoa A, Krakower DS, Marcus JL. Nondaily Use of HIV Preexposure Prophylaxis in a Large Online Survey of Primarily Men Who Have Sex With Men in the United States. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):182-188. doi: 10.1097/QAI.0000000000002332.

    PubMed 32168169

  • Saberi P, Scott HM. On-Demand Oral Pre-exposure Prophylaxis with Tenofovir/Emtricitabine: What Every Clinician Needs to Know. J Gen Intern Med. 2020 Apr;35(4):1285-1288. doi: 10.1007/s11606-020-05651-2. Epub 2020 Jan 21.

    PubMed 31965523

  • 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.

    PubMed 28913659

  • Tolley EE, Zangeneh SZ, Chau G, Eron J, Grinsztejn B, Humphries H, Liu A, Siegel M, Bertha M, Panchia R, Li S, Cottle L, Rinehart A, Margolis D, Jennings A, McCauley M, Landovitz RJ. Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077. AIDS Behav. 2020 Sep;24(9):2520-2531. doi: 10.1007/s10461-020-02808-2.

    PubMed 32052214

  • Whitfield THF, Parsons JT, Rendina HJ. Rates of Pre-exposure Prophylaxis Use and Discontinuation Among a Large U.S. National Sample of Sexual Minority Men and Adolescents. Arch Sex Behav. 2020 Jan;49(1):103-112. doi: 10.1007/s10508-019-01602-z. Epub 2019 Dec 16.

    PubMed 31845148

  • Parsons JT, Rendina HJ, Lassiter JM, Whitfield TH, Starks TJ, Grov C. Uptake of HIV Pre-Exposure Prophylaxis (PrEP) in a National Cohort of Gay and Bisexual Men in the United States. J Acquir Immune Defic Syndr. 2017 Mar 1;74(3):285-292. doi: 10.1097/QAI.0000000000001251.

    PubMed 28187084

  • Wagner GA, Wu KS, Anderson C, Burgi A, Little SJ. Predictors of Human Immunodeficiency Virus Pre-Exposure Prophylaxis (PrEP) Uptake in a Sexual Health Clinic With Rapid PrEP Initiation. Open Forum Infect Dis. 2023 Feb 8;10(3):ofad060. doi: 10.1093/ofid/ofad060. eCollection 2023 Mar.

    PubMed 36968957

  • Matacotta JJ, Rosales-Perez FJ, Carrillo CM. HIV Preexposure Prophylaxis and Treatment as Prevention - Beliefs and Access Barriers in Men Who Have Sex With Men (MSM) and Transgender Women: A Systematic Review. J Patient Cent Res Rev. 2020 Jul 27;7(3):265-274. doi: 10.17294/2330-0698.1737. eCollection 2020 Summer.

    PubMed 32760758

  • Ogunbajo A, Storholm ED, Ober AJ, Bogart LM, Reback CJ, Flynn R, Lyman P, Morris S. Multilevel Barriers to HIV PrEP Uptake and Adherence Among Black and Hispanic/Latinx Transgender Women in Southern California. AIDS Behav. 2021 Jul;25(7):2301-2315. doi: 10.1007/s10461-021-03159-2. Epub 2021 Jan 29.

    PubMed 33515132

Questions about this trial

What is this clinical trial studying?

A study testing eSTEP in people with Pre-Exposure Prophylaxis (PrEP), run by San Diego State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP Initiation (time frame: Assess throughout the 24 weeks after study enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06159582, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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