Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159582
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-11-28
Brief Title:
eSTEP An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
eSTEP An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eSTEP
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 raciallyethnically diverse transgender women TW and gay bisexual and other men who have sex with men GBMSM disproportionately impacted by the HIV epidemic
To reach this goal the investigators will compare study outcomes among persons randomized to use a mobile app eSTEP intervention tailored to the unique needs of TW and GBMSM with interactive components delivered before in-person HIV testing and PrEP initiation visit and interactive components delivered after PrEP is initiated The eSTEP group will be compared to usual HIV testing and PrEP care
To reach this goal the investigators will compare study outcomes among persons randomized to use a mobile app eSTEP intervention tailored to the unique needs of TW and GBMSM with interactive components delivered before in-person HIV testing and PrEP initiation visit and interactive components delivered after PrEP is initiated The eSTEP group will be compared to usual HIV testing and PrEP care
Detailed Description:
Study Design
The investigators propose to evaluate the feasibility acceptability and preliminary impact of eSTEP in a pilot RCT with transgender women TW and gay bisexual and other men who have sex with men GBMSM who are either PrEP naïve or have not been taking PrEP for at least 3 months randomized 21 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 ie app with interactive PrEP components delivered before in-person HIV testing at a university-based HIV treatment and prevention clinic to increase PrEP uptake and components to optimize PrEP adherence and persistence delivered after the participant tests negative for HIV and agrees to start PrEP eSTEP will be tailored to the unique needs of TW and GBMSM to optimize its impact and relevance for each group
eSTEP is grounded in the Information Motivation Behavioral Skills model IMB and also draws from a model of technology adoption eSTEP intervention components are
HIV Testing and PrEP Information
Identify and Addressing Barriers to PrEP Uptake and Stigma
PrEP Eligibility Survey and Preparing to Start PrEP
HIV Testing Visit Preparation
Appointment Scheduling
PrEP Adherence Reminders Self-monitoring for those who start PrEP
Adherence Feedback
PrEP Appointment Reminders
PrEP and Risk Reduction Information Control arm participants will not be offered the eSTEP mobile app and will receive information about how to schedule their HIV testing appointment at the HIV treatment and prevention clinic on their own which is the standard procedure for the clinic Community resources will be also provided electronically to control and treatment arm participants
Study Sample
Recruitment will be 120 adult 18 years and older GBMSM and TW participants n 85 GBMSM n 35 TW and will reflect at least 50 Black andor Latinx participants to ensure that eSTEP is piloted among persons most at risk for HIV This will allow the investigators to explore differences eg by geder race and ethnicity for eSTEP to inform future trials
Recruitment and Clinical Sites
Participants will be recruited from a university-based HIV treatment and prevention clinic as well as in the local San Diego GBMSM and TW communities through the following ways a ads on social media sites eg FacebookInstagram Grindr 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 with our existing GBMSM and TW Community Advisory Boards CABs and partner community organizations d via a part-time recruiter a peer recruiter or someone with experience in the community
Enrollment Randomization and Follow-up Visits
Study candidates will complete a short online pre-screening survey to assess eligibility on REDCap Preliminarily eligible participants will complete the enrollment visit over Zoom to verify eligibility and complete online written consent After informed consent participants will complete an online 30- to 45-minute baseline survey All participants will be provided with community resources electronically by the study coordinator and asked to schedule 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 that receives a positive test for HIV during the trial will receive appropriate post-test counseling and treatment by the HIV treatment and prevention clinic staff All participants will also be provided 3-4 dried blood spot DBS testing kits to self-collect their DBS specimen for the TFV-DP analysis PrEP adherence with a detailed instruction sheet and link to a video demonstration of the DBS collect procedure These kits and the first DBS collection may take place either in person at the HIV treatment and prevention clinic or if necessary by mail
Participants will be randomized 21 either to the intervention arm eSTEP and usual care or to the control arm HIV testing usual care using the randomization feature in REDCap Participants randomized to the treatment arm eSTEP and usual care will be guided through setting up their user account and user profile provided with basic training on how to navigate and use intervention components and given the opportunity to ask questions Participants in the treatment arm will have immediate access to eSTEP as part of the initial visit
Participants will undergo an online 30-45-minute survey at week 12 and week 24 All participants receiving either daily oral or on-demand 2-1-1 PrEP will be asked to complete and submit a DBS specimen at week 12 and week 24 using the kits provided earlier in person at HIV treatment and prevention clinic or by mail and will be seen in-person at the HIV treatment and prevention clinic for usual PrEP care follow-up Participant survey data will be captured in Qualtrics and along with clinical study data collected from HIV treatment and prevention clinic HIV testing and PrEP care appointments will be captured in our web-based case report forms CRFs using REDCap Research Electronic Data Capture open software and securely transferred to SDSU via a deidentified file For treatment arm participants survey data collection may occur on a mobile device that can access the internet and will be housed on the San Diego State University server
Study retention protocols involve the use of multiple contact methods including telephone calls text messages e-mail reminders social media and contact information for a friendfamily member - and with permission for the use of each
Exit Interviews
10 GBMSM and 10 TW in the eSTEP intervention arm only will be purposively selected high eSTEP user vs low user diversity in raceethnicity for a 30-60-minute exit interview to assess their experience in the intervention suggestions for modifications to the existing interface suggestions for new features and changes to any study procedures
The investigators propose to evaluate the feasibility acceptability and preliminary impact of eSTEP in a pilot RCT with transgender women TW and gay bisexual and other men who have sex with men GBMSM who are either PrEP naïve or have not been taking PrEP for at least 3 months randomized 21 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 ie app with interactive PrEP components delivered before in-person HIV testing at a university-based HIV treatment and prevention clinic to increase PrEP uptake and components to optimize PrEP adherence and persistence delivered after the participant tests negative for HIV and agrees to start PrEP eSTEP will be tailored to the unique needs of TW and GBMSM to optimize its impact and relevance for each group
eSTEP is grounded in the Information Motivation Behavioral Skills model IMB and also draws from a model of technology adoption eSTEP intervention components are
HIV Testing and PrEP Information
Identify and Addressing Barriers to PrEP Uptake and Stigma
PrEP Eligibility Survey and Preparing to Start PrEP
HIV Testing Visit Preparation
Appointment Scheduling
PrEP Adherence Reminders Self-monitoring for those who start PrEP
Adherence Feedback
PrEP Appointment Reminders
PrEP and Risk Reduction Information Control arm participants will not be offered the eSTEP mobile app and will receive information about how to schedule their HIV testing appointment at the HIV treatment and prevention clinic on their own which is the standard procedure for the clinic Community resources will be also provided electronically to control and treatment arm participants
Study Sample
Recruitment will be 120 adult 18 years and older GBMSM and TW participants n 85 GBMSM n 35 TW and will reflect at least 50 Black andor Latinx participants to ensure that eSTEP is piloted among persons most at risk for HIV This will allow the investigators to explore differences eg by geder race and ethnicity for eSTEP to inform future trials
Recruitment and Clinical Sites
Participants will be recruited from a university-based HIV treatment and prevention clinic as well as in the local San Diego GBMSM and TW communities through the following ways a ads on social media sites eg FacebookInstagram Grindr 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 with our existing GBMSM and TW Community Advisory Boards CABs and partner community organizations d via a part-time recruiter a peer recruiter or someone with experience in the community
Enrollment Randomization and Follow-up Visits
Study candidates will complete a short online pre-screening survey to assess eligibility on REDCap Preliminarily eligible participants will complete the enrollment visit over Zoom to verify eligibility and complete online written consent After informed consent participants will complete an online 30- to 45-minute baseline survey All participants will be provided with community resources electronically by the study coordinator and asked to schedule 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 that receives a positive test for HIV during the trial will receive appropriate post-test counseling and treatment by the HIV treatment and prevention clinic staff All participants will also be provided 3-4 dried blood spot DBS testing kits to self-collect their DBS specimen for the TFV-DP analysis PrEP adherence with a detailed instruction sheet and link to a video demonstration of the DBS collect procedure These kits and the first DBS collection may take place either in person at the HIV treatment and prevention clinic or if necessary by mail
Participants will be randomized 21 either to the intervention arm eSTEP and usual care or to the control arm HIV testing usual care using the randomization feature in REDCap Participants randomized to the treatment arm eSTEP and usual care will be guided through setting up their user account and user profile provided with basic training on how to navigate and use intervention components and given the opportunity to ask questions Participants in the treatment arm will have immediate access to eSTEP as part of the initial visit
Participants will undergo an online 30-45-minute survey at week 12 and week 24 All participants receiving either daily oral or on-demand 2-1-1 PrEP will be asked to complete and submit a DBS specimen at week 12 and week 24 using the kits provided earlier in person at HIV treatment and prevention clinic or by mail and will be seen in-person at the HIV treatment and prevention clinic for usual PrEP care follow-up Participant survey data will be captured in Qualtrics and along with clinical study data collected from HIV treatment and prevention clinic HIV testing and PrEP care appointments will be captured in our web-based case report forms CRFs using REDCap Research Electronic Data Capture open software and securely transferred to SDSU via a deidentified file For treatment arm participants survey data collection may occur on a mobile device that can access the internet and will be housed on the San Diego State University server
Study retention protocols involve the use of multiple contact methods including telephone calls text messages e-mail reminders social media and contact information for a friendfamily member - and with permission for the use of each
Exit Interviews
10 GBMSM and 10 TW in the eSTEP intervention arm only will be purposively selected high eSTEP user vs low user diversity in raceethnicity for a 30-60-minute exit interview to assess their experience in the intervention suggestions for modifications to the existing interface suggestions for new features and changes to any study procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None