Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships

NCT07246057 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-13

No results posted yet for this study

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. 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.

Conditions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Thomas Jefferson University

    collaborator OTHER
  • University of Pennsylvania

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2028-06-30
Completion
2028-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246057 on ClinicalTrials.gov