Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships

Official title

Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships (STEP-UP)

Overview

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.

Detailed description

HIV remains a significant public health challenge in the United States, with new diagnoses concentrated among key populations that continue to experience higher rates relative to the general population. Pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention tool, but its adoption has been hindered by barriers to healthcare access, resulting in suboptimal utilization rates and limiting its potential to reduce HIV incidence. Telehealth delivery of PrEP (telePrEP) has emerged as a promising strategy for expanding access by overcoming barriers such as transportation, scheduling, and privacy concerns. However, evidence suggests that its reach to individuals at elevated risk for HIV acquisition remains limited, likely due to limitations in technology access, awareness of PrEP, and trust in healthcare systems. To address these challenges, the investigators propose to develop and evaluate STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships), an innovative model 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 people who could benefit from HIV prevention tools, integrating telehealth PrEP delivery into their existing infrastructure through partnership with a local telePrEP 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 people who could benefit from HIV prevention tools. Through a 3-year observational hybrid implementation-effectiveness pilot study, the investigators aim to: (1) identify multi-level determinants of STEP-UP implementation and collaboratively develop protocols through client interviews (n=20) and workflow observations; (2) characterize implementation outcomes including acceptability, cost, and reach to people who could benefit from HIV prevention tools through surveys with STEP-UP participants (n=50), implementation interviews with stakeholders (n=12), and analysis of program data from CBO partner sites; and (3) assess the preliminary effectiveness of STEP-UP in increasing PrEP prescription rates compared to the current direct-to-consumer model through analysis of program data from the telePrEP 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 vi
• 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]

Secondary outcome measures (2)

• Acceptability of STEP-UP [Time frame: Immediately after initial engagement with Community TelePrEP Navigator and 2-4 weeks after initial engagement]
• Usability of STEP-UP [Time frame: Immediately after initial engagement with Community TelePrEP Navigator and 2-4 weeks after initial engagement]

Eligibility criteria

Inclusion -

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-

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT07246057 · 1R34MH139435 · 1R34MH139435

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗