Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships

NCT07246057 | Recruiting

• 1 other identifier: 1R34MH139435
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is STEP-UP acceptable and feasible to implement in community settings?
2. 2.Does STEP-UP increase PrEP prescription rates compared to the existing direct-to-consumer telehealth model?
3. 3.Complete surveys about their experiences with the program
4. 4.Participate in an interview to share their perspectives and feedback about the program.

Conditions

HIV

Keywords

Pre-exposure prophylaxis; Telehealth; Community-based organizations; Implementation science

Outcome Measures

Primary Outcomes (1)

• PrEP Prescription Rate

  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.

  18-month pilot period

Secondary Outcomes (2)

• Acceptability of STEP-UP

  Immediately after initial engagement with Community TelePrEP Navigator and 2-4 weeks after initial engagement

• Usability of STEP-UP

  Immediately after initial engagement with Community TelePrEP Navigator and 2-4 weeks after initial engagement

Study Arms (2)

STEP-UP Partner Site Model

EXPERIMENTAL

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: STEP-UP

Direct-to-Consumer Telehealth Model

ACTIVE COMPARATOR

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.

Behavioral: Philadelphia TelePrEP Program Direct-to-Consumer Model

Interventions

Philadelphia TelePrEP Program Direct-to-Consumer Model BEHAVIORAL

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.

Direct-to-Consumer Telehealth Model

STEP-UP BEHAVIORAL

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

Also known as: Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships

STEP-UP Partner Site Model

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Inclusion - Client Interviews: 1. At least 18 years of age or older 2. Have received services or participated in programming at a partner CBO in the past 12 months 3. Currently live in the Philadelphia metropolitan area 4. Able to provide informed consent Staff Interviews: 1. At least 18 years of age or older 2. Currently employed at Philadelphia telePrEP Program or a partner CBO 3. Serve in a client-facing role (e.g., outreach specialists) or leadership position (e.g., program coordinators) at one of the aforementioned organizations 4. Have been in their current role for at least 6 months 5. Able to provide informed consent Client Surveys: 1. At least 16 years of age or older 2. Have engaged with a Community TelePrEP Navigator through a partner site CBO to schedule a telehealth appointment with a PrEP provider 3. Currently live in the Philadelphia metropolitan area 4. Able to provide informed consent Exclusion- 1. Under 16 years of age (clients surveys) or under 18 years of age (staff interviews or client interviews) 2. Do not currently live in the Philadelphia metropolitan area 3. Unable to provide informed consent due to cognitive impairment or other factors 4. Individuals who pose a safety risk to research staff or other participants 5. Clients currently living with HIV

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Pennsylvania: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Central Study Contacts

Stephen Bonett, PhD

CONTACT

215-573-4299; stepdo@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: March 26, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: The investigators will submit our data to the NDA as soon as possible after study completion and data cleaning, and no later than upon publication of the primary study findings. The investigators will protect the rights and privacy of human subjects who participate in sponsored research by redacting all identifiers, and adopting other strategies to minimize risks of unauthorized disclosure of personal identifiers. The NDA will determine the duration of data preservation. To date, the NDA has not removed any data that has been deposited in the repository.
• Access Criteria: Researchers interested in accessing the data will follow the NDA standard access procedures. The NDA Data Access Committee will review all requests and determine which ones to approve. If granted access, researchers will have permission to use the data for one year, with the option to renew their access request.

Locations

US (1)