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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Arm | Placebo Comparator | Usual PrEP clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Of the 113 participants, 24 identified as a TW.
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| Name | Affiliation | Role |
|---|---|---|
| Keith J Horvath, PhD | San Diego State University | Principal Investigator |
| Susan J Little, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University - Department of Psychology | San Diego | California | 92120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27098408 | Background | 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. | |
| 31180995 | Background | 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. |
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Will share summary statistics, aggregated data. No deidentified data will be publicly available.
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| ID | Title | Description |
|---|---|---|
| FG000 | eSTEP Arm | 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. eSTEP: 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 Care: Usual PrEP clinical care |
| FG001 | Control Arm | Usual PrEP clinical care Usual Care: Usual PrEP clinical care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All persons who completed informed consent and enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | eSTEP Arm | 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. eSTEP: 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 Care: Usual PrEP clinical care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who enrolled on the study | Posted | Count of Participants | Participants | Assess throughout the 24 weeks after study enrollment. |
|
Adverse event data were collected over a period of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eSTEP Arm | 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. eSTEP: 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 Care: Usual PrEP clinical care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide | General disorders | Non-systematic Assessment | The suicide was reported by a family member. This was an unanticipated grade 5 event, although it was unrelated to receiving the intervention (i.e., the participant did not initiate PrEP or communicate any suicidal intent). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keith Horvath | San Diego State University | 6196943346 | khorvath@sdsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2026 | Apr 29, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2024 | Apr 29, 2026 | ICF_001.pdf |
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2-arm RCT with 2:1 randomization to eSTEP treatment group or usual care control group
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| Usual Care | Behavioral | Usual PrEP clinical care |
|
| 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 |
| 26334052 | Background | 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. |
| 24384592 | Background | 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. |
| 21091279 | Background | 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. |
| 34014998 | Background | 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. |
| 32168169 | Background | 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. |
| 31965523 | Background | 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. |
| 28913659 | 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. |
| 32052214 | Background | 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. |
| 31845148 | Background | 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. |
| 28187084 | Background | 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. |
| 36968957 | Background | 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. |
| 32760758 | Background | 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. |
| 33515132 | Background | 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. |
| 27900502 | Background | Koechlin FM, Fonner VA, Dalglish SL, O'Reilly KR, Baggaley R, Grant RM, Rodolph M, Hodges-Mameletzis I, Kennedy CE. Values and Preferences on the Use of Oral Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Multiple Populations: A Systematic Review of the Literature. AIDS Behav. 2017 May;21(5):1325-1335. doi: 10.1007/s10461-016-1627-z. |
| 35144102 | Background | Loh KP, Liu J, Ganzhorn S, Sanabria G, Schnall R. Establishing a usability cut-point for the health information technology usability evaluation scale (Health-ITUES). Int J Med Inform. 2022 Apr;160:104713. doi: 10.1016/j.ijmedinf.2022.104713. Epub 2022 Feb 5. |
| 35963945 | Background | Jacobson TA, Kler JS, Bae Y, Chen J, Ladror DT, Iyer R, Nunes DA, Montgomery ND, Pleil JD, Funk WE. A state-of-the-science review and guide for measuring environmental exposure biomarkers in dried blood spots. J Expo Sci Environ Epidemiol. 2023 Jul;33(4):505-523. doi: 10.1038/s41370-022-00460-7. Epub 2022 Aug 13. |
| Background | Fisher WA, Fisher JD, Harman J, The information-motivation-behavioral skills model: A general social psychological approach to understanding and promoting health behavior. In Wallston JSKA, ed. Social psychological foundations of health and illness. Blackwell Publishing. 2003; 82-106. |
| BG001 | Control Arm | Usual PrEP clinical care Usual Care: Usual PrEP clinical care |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Arm | Usual PrEP clinical care Usual Care: Usual PrEP clinical care |
|
|
| Primary | 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 initiated PrEP at the baseline study visit and who were in PrEP care at week 12 | Posted | Count of Participants | Participants | Participants who were retained in PrEP care through week 12 after enrollment |
|
|
|
| Primary | 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 initiated PrEP at a previous study visit and who were retained in PrEP care at week 24 | Posted | Count of Participants | Participants | Participants who were retained in PrEP care at week 24 |
|
|
|
| Primary | 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. | Participants who had initiated PrEP at 12 weeks or at a prior study visit | Posted | Count of Participants | Participants | Assessed at 12 weeks after study enrollment |
|
|
|
| Primary | 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. | Participants who had initiated PrEP at 24 weeks or at a prior study visit | Posted | Count of Participants | Participants | Assessed at 24 weeks after study enrollment |
|
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|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Control Arm | Usual PrEP clinical care Usual Care: Usual PrEP clinical care | 1 | 37 | 1 | 37 | 0 | 37 |
|
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