Pre-Exposure Prophylaxis (PrEP)
Conditions
Keywords
Pre-Exposure Prophylaxis (PrEP), HIV Prevention
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.
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.
Interventions
BEHAVIORALeSTEP
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.
BEHAVIORALUsual Care
Usual PrEP clinical care
Sponsors
San Diego State University
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
2-arm RCT with 2:1 randomization to eSTEP treatment group or usual care control group
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Initiation | Assess throughout the 24 weeks after study enrollment. | 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. |
| Retention in PrEP Care at 12 Weeks | Participants who were retained in PrEP care through week 12 after enrollment | 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). |
| Retention in PrEP Care at 24 Weeks | Participants who were retained in PrEP care at week 24 | 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). |
| Protective PreP Adherence at 12 Weeks | Assessed at 12 weeks after study enrollment | 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. |
| Protective PrEP Adherence at 24 Weeks | Assessed at 24 weeks after study enrollment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKeith J Horvath, PhD
San Diego State University
PRINCIPAL_INVESTIGATORSusan J Little, MD
University of California, San Diego
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.3 Years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 113 participants |
| Sex/Gender, Customized Male | 89 Participants |
| Sex/Gender, Customized Transgender Woman | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 1 / 37 |
| other Total, other adverse events | 0 / 76 | 0 / 37 |
| serious Total, serious adverse events | 0 / 76 | 1 / 37 |
Outcome results
None listed