NCT07246057 · University of Pennsylvania
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships
(STEP-UP)
What this study is about
The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools. STEP-UP is an innovative model for PrEP delivery that positions community-based organizations (CBOs) as hubs for PrEP access.
View original scientific description
The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools. STEP-UP is an innovative model for PrEP delivery that positions community-based organizations (CBOs) as hubs for PrEP access. STEP-UP builds on the established trust, community expertise, and comprehensive services of CBOs serving individuals who could benefit from HIV prevention tools, integrating telehealth PrEP delivery into their existing infrastructure through partnership with a local telehealth PrEP program. By enabling CBOs to offer telePrEP navigation within their array of health and social services, STEP-UP creates accessible, comprehensive care centers that address barriers to PrEP access faced by individuals who could benefit from HIV prevention tools. The main questions it aims to answer are: 1. Is STEP-UP acceptable and feasible to implement in community settings? 2. Does STEP-UP increase PrEP prescription rates compared to the existing direct-to-consumer telehealth model? Researchers will compare people who receive telehealth PrEP services through STEP-UP at community-based organizations to those who access telehealth PrEP through the existing direct-to-consumer telehealth model. Some participants will: 1. Complete surveys about their experiences with the program 2. Participate in an interview to share their perspectives and feedback about the program.
Interventions
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 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
BEHAVIORAL
Philadelphia TelePrEP Program Direct-to-Consumer Model
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.
Primary outcome measures
PrEP Prescription Rate
Time frame: 18-month pilot period
The proportion of clients who receive a PrEP prescription among those who schedule a telehealth appointment with a PrEP provider. This measure will be compared between clients referred through the STEP-UP partner site model and those engaged through the existing direct-to-client telehealth model.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- - Client Interviews:
- At least 18 years of age or older
- Have received services or participated in programming at a partner CBO in the past 12 months
- Currently live in the Philadelphia metropolitan area
- Able to provide informed consent Staff Interviews:
- At least 18 years of age or older
- Currently employed at Philadelphia telePrEP Program or a partner CBO
- Serve in a client-facing role (e.g., outreach specialists) or leadership position (e.g., program coordinators) at one of the aforementioned organizations
- Have been in their current role for at least 6 months
- Able to provide informed consent Client Surveys:
- At least 16 years of age or older
- Have engaged with a Community TelePrEP Navigator through a partner site CBO to schedule a telehealth appointment with a PrEP provider
- Currently live in the Philadelphia metropolitan area
- Able to provide informed consent
Exclusion criteria
- Under 16 years of age (clients surveys) or under 18 years of age (staff interviews or client interviews)
- Do not currently live in the Philadelphia metropolitan area
- Unable to provide informed consent due to cognitive impairment or other factors
- Individuals who pose a safety risk to research staff or other participants
- Clients currently living with HIV
Where
- Philadelphia, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH), Thomas Jefferson University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations