Telehealth Program for HIV Prevention
(STEP-UP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to make HIV prevention tools like PrEP more accessible through community-based organizations (CBOs) using telehealth. The researchers aim to determine if this approach, called STEP-UP, is easier and more effective than current direct-to-consumer telehealth services. Individuals who have used services at a partner CBO in the past year and live in the Philadelphia area may be suitable candidates. Participants will share their experiences and feedback to help refine the program. As an unphased trial, this study provides a unique opportunity to contribute to innovative HIV prevention strategies and enhance community health.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that the STEP-UP model is safe for expanding access to PrEP?
Research has shown that using telehealth for PrEP (pre-exposure prophylaxis) is generally safe and easy to use. A review of telePrEP programs in the U.S. found that these programs help people access HIV prevention tools without major safety issues. Studies also indicate that telehealth PrEP services are as safe as traditional in-person methods. They can even address challenges like stigma and transportation, making it easier for people to receive care.
PrEP itself is a proven and FDA-approved method to prevent HIV, which supports its safety. While the STEP-UP model is a new way to provide PrEP through telehealth, evidence from similar programs suggests that participants can expect a safe experience with few side effects.12345Why are researchers excited about this trial?
Researchers are excited about the STEP-UP program for HIV prevention because it promises to make telehealth PrEP services more accessible to communities that need them. Unlike the standard direct-to-consumer telehealth model, STEP-UP creates a partner site model, setting up private spaces at community-based organizations for telehealth visits. It also trains local staff as Community TelePrEP Navigators who assist clients with scheduling and education, enhancing community engagement. This approach could significantly enhance the reach and efficiency of PrEP services, potentially reducing HIV transmission rates by making prevention tools easier to access.
What evidence suggests that the STEP-UP model is effective for expanding access to PrEP for HIV prevention?
Research has shown that telehealth methods for delivering PrEP (a medication to prevent HIV), such as the STEP-UP program, can effectively increase its use. This trial will compare the STEP-UP Partner Site Model to the Direct-to-Consumer Telehealth Model. A review found that telePrEP programs successfully reach individuals who might not visit traditional healthcare facilities. Studies indicate that telehealth can help overcome barriers like stigma and transportation issues. Early results suggest that telehealth models are practical and well-received by users, making it easier to access HIV prevention tools. By collaborating with community-based organizations, STEP-UP builds on trust and local knowledge to enhance these benefits further.23678
Are You a Good Fit for This Trial?
This trial is for people aged 16 or older who live in the Philadelphia area and have used services at a partner community organization in the past year, as well as staff members (in client-facing or leadership roles) at these organizations who've worked there for at least 6 months. All participants must be able to give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Development and Refinement
Collaborative development and refinement of the STEP-UP model, including establishing private spaces, providing technology, and training staff
Implementation
Implementation of the STEP-UP model at community-based organizations, including telehealth visits and PrEP education
Follow-up
Participants are monitored for acceptability and usability of the STEP-UP model
What Are the Treatments Tested in This Trial?
Interventions
- STEP-UP
Trial Overview
The study compares two ways of getting HIV prevention medicine (PrEP): one through community-based organizations using telehealth support (STEP-UP), and another through a direct-to-consumer telehealth model. Participants may complete surveys or interviews about their experiences.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
STEP-UP is a partner site model that aims to expand access to telehealth PrEP services for people who could benefit from HIV prevention tools. The first year of the proposed project is dedicated to collaboratively developing and refining the specifics of the STEP-UP model. While the final model will be determined by this formative process, key components will likely include: 1) Establishing a private, on-site space at community-based organizations (CBOs) where clients can engage in telehealth visits with remote PrEP providers; 2) Providing CBOs with the necessary technology and equipment to facilitate telehealth visits; 3) Training CBO staff as Community TelePrEP Navigators to help clients prepare for and follow-up after telehealth appointments, and conduct community-based PrEP education and linkage. Clients referred through the STEP-UP model can schedule appointments with assistance from a Community TelePrEP Navigator or through documented referrals to the self-scheduling tool on the
The existing direct-to-consumer model for telehealth PrEP delivery through the Philadelphia TelePrEP Program. In this model, appointments can be scheduled with assistance from patient navigators and chat operators, or through the self-scheduling tool on the website. This represents the current standard approach for telehealth PrEP service delivery and serves as the comparison group for assessing the preliminary effectiveness of the STEP-UP model.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Thomas Jefferson University
Collaborator
Citations
Effectiveness, Acceptability, and Feasibility of a Telehealth ...
This study aims to assess the effectiveness, acceptability, and feasibility of a telehealth HIV PrEP care intervention, PrEPTECH, in increasing PrEP uptake.
Pilot outcomes of a telehealth model for youth PrEP ...
This study evaluated the feasibility and effectiveness of a telehealth model for youth PrEP (TelePrEP) among individuals assigned male at birth at risk for HIV ...
Telehealth Models for PrEP Delivery: A Systematic Review of ...
This study presents a systematic review of telePrEP programs in the US, aiming to describe model characteristics and summarize clinical, implementation, and ...
Telehealth Practitioner's Guide for HIV Prevention and Care
Telehealth reduces stigma, mitigates the need for childcare, minimizes healthcare system navigation, and eliminates barriers to care. (i.e., transportation), ...
Delivery of the HIV Service and Telemedicine Through ...
Delivery of the HIV Service and Telemedicine Through Effective Patient-Reported Outcomes (+STEP) Intervention to Increase Screening and Treatment of Mental ...
Streamlining Telehealth for Expanded PrEP Utilization ...
Behavioral : STEP-UP. STEP-UP is a partner site model that aims to expand access to telehealth PrEP services for people who could benefit from HIV prevention ...
Effectiveness, Acceptability, and Feasibility of a Telehealth ...
This study aims to assess the effectiveness, acceptability, and feasibility of a telehealth HIV PrEP care intervention, PrEPTECH, in increasing PrEP uptake.
Pilot outcomes of a telehealth model for youth PrEP ( ...
This study evaluated the feasibility and effectiveness of a telehealth model for youth PrEP (TelePrEP) among individuals assigned male at birth ...
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