Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT07246057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships (STEP-UP)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP-UP
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R34MH139435 | NIH | None | https://reporter.nih.gov/quic… | View |