HIVSTEP-UPNCT07246057
Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships
A study testing STEP-UP and Philadelphia TelePrEP Program Direct-to-Consumer Model in people with HIV, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- STEP-UP and Philadelphia TelePrEP Program Direct-to-Consumer Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 15 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stephen Bonett, PhD, RN, 215-573-4299, stepdo@upenn.edu
About this study
Official title: Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships (STEP-UP)
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:
- Is STEP-UP acceptable and feasible to implement in community settings?
- Does STEP-UP increase PrEP prescription rates compared to the existing direct-to-consumer telehealth model?
Read more
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:
- Complete surveys about their experiences with the program
- Participate in an interview to share their perspectives and feedback about the program.
Read the 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.
- Conditions
- HIV
- Being tested
- STEP-UP, Philadelphia TelePrEP Program Direct-to-Consumer Model
- Keywords
- Pre-exposure prophylaxis, Telehealth, Community-based organizations, Implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEP-UPBehavioural
Also called Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships
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 ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Philadelphia TelePrEP Program Direct-to-Consumer Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18-month pilot period
Secondary outcomes (2)
Acceptability of STEP-UP
Client-reported acceptability of the STEP-UP model measured using the 8-item Client Satisfaction Questionnaire. The total scores for this scale range from 8 to 32, with the higher number indicating greater acceptability. This validated measure assesses overall satisfaction with services received.
Measured: Immediately after initial engagement with Community TelePrEP Navigator and 2-4 weeks after initial engagement
Usability of STEP-UP
Client-reported usability of the STEP-UP model measured using the 2-item Usability Metric for User Experience LITE scale. The total scores for this scale range from 2 to 14, with the higher number indicating greater usability. This validated measure assesses ease of use of the telehealth PrEP navigation services.
Measured: Immediately after initial engagement with Community TelePrEP Navigator and 2-4 weeks after initial engagement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start26 Mar 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Thomas Jefferson University
- Responsible party
- Principal investigator, Stephen Bonett, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246057
- Sponsor's protocol ID
- 1R34MH139435
- Other IDs
- 1R34MH139435
- Acronym
- STEP-UP
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data generated by this study will be archived in the National Institute of Mental Health Data Archive (NDA). The NDA is a secure, federated data repository that provides infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. All direct identifiers will be removed and indirect identifiers will be generalized to prevent re-identification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships (STEP-UP)
- ClinicalTrials.gov ID
- NCT07246057
- Acronym / sponsor ID
- STEP-UP / 1R34MH139435
- Conditions
- HIV
- Keywords
- Pre-exposure prophylaxis, Telehealth, Community-based organizations, Implementation science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Thomas Jefferson University
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is STEP-UP acceptable and feasible to implement in community settings?
- 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:
- Complete surveys about their experiences with the program
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEP-UP Partner Site Model | Experimental | Behavioral: STEP-UPSTEP-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 |
| Direct-to-Consumer Telehealth Model | Active comparator | Behavioral: Philadelphia TelePrEP Program Direct-to-Consumer ModelThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- At least 18 years of age or older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEP-UPAlso: Streamlining Telehealth for Expanded PrEP Utilization through community PartnershipsSTEP-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 | Behavioural | STEP-UP Partner Site Model |
| Philadelphia TelePrEP Program Direct-to-Consumer ModelThe 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. | Behavioural | Direct-to-Consumer Telehealth Model |
Primary outcome
PrEP Prescription Rate
Time frame: 18-month pilot period
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data generated by this study will be archived in the National Institute of Mental Health Data Archive (NDA). The NDA is a secure, federated data repository that provides infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. All direct identifiers will be removed and indirect identifiers will be generalized to prevent re-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEP-UP and Philadelphia TelePrEP Program Direct-to-Consumer Model in people with HIV, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Bonett, PhD (215-573-4299, stepdo@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Prescription Rate (time frame: 18-month pilot period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.