Recruiting

STEP-UP

Sponsor:

University of Pennsylvania

Code:

NCT07246057

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

STEP-UP

Philadelphia TelePrEP Program Direct-to-Consumer Model

Study Details

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. 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

HIV

Study ID

NCT07246057

Start date

Mar 26, 2026

Status verified date

Aug, 2026

Completion date

Jul 15, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: STEP-UP Partner Site Model

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

active comparator: Direct-to-Consumer Telehealth 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.

Interventions

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

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 measure

  • PrEP Prescription Rate [ Time Frame: 18-month pilot period ]

Central Contacts and Locations

Central contacts

Stephen Bonett, PhD

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Stephen Bonett, PhD, RN

215-573-4299stepdo@upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-14.