HIV PreventionHOT4PrEPNCT05856942
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
A study testing Health service - home-based PrEP monitoring in people with HIV Prevention and Pre-exposure Prophylaxis, run by University of Washington at 1 site in United States.
Trial summary
The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Pre-exposure Prophylaxis, STI
- What is being tested?
- Health service - home-based PrEP monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2022to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be eligible to receive PrEP per PHSKC criteria
- Age ≥18 years
- Washington State resident
- Ability to speak, understand and read/write in English or Spanish
- Willing to provide contact information
- Willing to be randomized and adhere to study procedures
Who cannot join
- Recent (<4 weeks) "high risk" HIV exposure while off PrEP or symptoms of acute HIV
- No mailing address to receive sampling kits
- No working telephone number
- No smartphone or other device with internet access
- History of a bleeding disorder, or current or recent (≤7 days) use of anticoagulant medications
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
About this study
Official title: Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington
The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs.
Specific research aims are to:
- Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits.
- Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC.
- Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.
Read the detailed description
Pre-exposure prophylaxis (PrEP) is an established and effective method for HIV prevention, but lack of access to PrEP providers and the burden of quarterly monitoring visits remain barriers to PrEP uptake and retention, particularly for people of color and younger men who have sex with men (MSM). Home-based PrEP (HB-PrEP) monitoring could unburden medical systems and increase PrEP access, but whether this remote care option improves key clinical outcomes like PrEP retention is not known.
The study's specific aims are to:
- AIM 1: Evaluate the impact of HB-PrEP on PrEP retention and define the factors that influence HB-PrEP implementation. The investigators will conduct a type 1 hybrid randomized controlled trial comparing HB-PrEP as an implementation strategy (self-collected lab specimens from home and telehealth follow-up) to standard of care (SOC) at the Public Health-Seattle \& King County (PHSKC) Sexual Health Clinic (SHC). The study's primary outcome will be effectiveness of the implementation strategy measured as the rate of retention in PrEP care. In secondary analyses, investigators will utilize mixed methods to assess reach (proportion of persons offered HB-PrEP who choose to use it), and examine individual-level barriers and facilitators (B\&F) to PrEP retention (participant surveys and interviews) and system-level B\&F to HB-PrEP implementation (participant surveys and interviews, PHSKC staff interviews). Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits.
- AIM 2: Perform a cost analysis of HB-PrEP service implementation at the PHSKC SHC compared to SOC. Investigators will track resource use and prospectively collect unit costs for laboratory fees, healthcare worker time and other clinic resources to estimate the total monthly cost of providing HB-PrEP services overall and the monthly cost per person retained in PrEP care in the HB-PrEP and SOC arms. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC.
- AIM 3: Conduct a HB-PrEP scale-up assessment with healthcare organizations (HCO) and other key stakeholders to determine the scalability of HB-PrEP within Washington State. To evaluate institution-level factors that may impede or facilitate statewide HB-PrEP scale-up, investigators will conduct semi-structured interviews with key stakeholders from a countywide EHE HCO collaborative.
The Aim 1 study is a pragmatic, non-blinded, hybrid type 1 (clinical-implementation) RCT and includes mixed-methods assessments to evaluate both qualitative and quantitative data for the primary and secondary outcomes. Aim 3 is a qualitative study using in-depth interviews.
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis, STI
- Being tested
- Health service - home-based PrEP monitoring
- Keywords
- Implementation science, PrEP, Screening, Telehealth
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health service - home-based PrEP monitoringOther
Home-based PrEP care
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patients will receive standard PrEP care in the clinic including in-person visits for triannual (every 4 months) HIV \& STI screening and comprehensive sexual health care. |
| Home-based care | Experimental | Patients will have the option to complete their PrEP care from home including 1) self-collection of blood specimens for HIV, syphilis and creatinine; 2) self-swabs for extragenital GC/CT screening; and 3) telehealth follow-up. A maximum of two triannual follow-up visits per year may be conducted remotely; one visit per year must be in person. Participants also have the option to attend visits in person and are otherwise eligible to continue receiving comprehensive sexual health services in the clinic. Receives: Other: Health service - home-based PrEP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP retention
Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription
Measured: 18 months
Secondary outcomes (7)
Reach
Proportion of patients who successfully utilize home-based monitoring for at least 50% of triannual visits over the study period
Measured: 18 months
User satisfaction
Self-reported satisfaction with the assigned PrEP care strategy on Likert scale (1: very satisfied to 5: very dissatisfied)
Measured: Every 4 months up to 16 months and at study exit (on/after 18 months)
PrEP adherence
Self-reported adherence within prior 4 weeks to self-selected PrEP use strategy (daily vs event-driven PrEP); ordinal self-reported adherence scale from excellent to very poor
Measured: Every 4 months up to 16 months and at study exit (on/after 18 months)
Time to action on abnormal results
Time from receipt and review of abnormal monitoring or HIV/STI results to patient notification
Measured: Every 4 months up to 16 months and at study exit (on/after 18 months)
STI positivity rate
Composite asymptomatic STI (syphilis, gonorrhea, chlamydia) rate
Measured: Every 4 months up to 16 months and at study exit (on/after 18 months)
Barriers and facilitators of PrEP retention
In-depth interviews with study participants and clinic staff/administrators to understand B\&F of PrEP retention
Measured: Every 4 months starting at month 4 until target of 24 reached
Cost
"Real world" costs of PrEP delivery and retention in each arm (total dollars spent per individual retained on PrEP per month)
Measured: Month 12 through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start8 Mar 2022
- Primary completion8 Mar 2025 (estimated)
- Study completion8 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Tasso Inc.
- Responsible party
- Principal investigator, Chase Cannon, University of Washington
- Investigators
- Chase Cannon, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856942
- Sponsor's protocol ID
- STUDY00013871
- Acronym
- HOT4PrEP
- Status last verified
- May 2024
- First submitted
- 6 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cannon CA, Ramchandani MS, Golden MR. Feasibility of a novel self-collection method for blood samples and its acceptability for future home-based PrEP monitoring. BMC Infect Dis. 2022 May 13;22(1):459. doi: 10.1186/s12879-022-07432-0.
PubMed 35562692Cannon C, Holzhauer K, Golden M. Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 23;13:e56587. doi: 10.2196/56587.
PubMed 39312771
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington
- ClinicalTrials.gov ID
- NCT05856942
- Acronym / sponsor ID
- HOT4PrEP / STUDY00013871
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis, STI
- Keywords
- Implementation science, PrEP, Screening, Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Tasso Inc.
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 8 Mar 2025 (estimated)
- Study completion
- 8 Sep 2025 (estimated)
- First posted
- 12 May 2023 (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 study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs.
Specific research aims are to:
- Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits.
- Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC.
- Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.
Detailed description
Pre-exposure prophylaxis (PrEP) is an established and effective method for HIV prevention, but lack of access to PrEP providers and the burden of quarterly monitoring visits remain barriers to PrEP uptake and retention, particularly for people of color and younger men who have sex with men (MSM). Home-based PrEP (HB-PrEP) monitoring could unburden medical systems and increase PrEP access, but whether this remote care option improves key clinical outcomes like PrEP retention is not known.
The study's specific aims are to:
- AIM 1: Evaluate the impact of HB-PrEP on PrEP retention and define the factors that influence HB-PrEP implementation. The investigators will conduct a type 1 hybrid randomized controlled trial comparing HB-PrEP as an implementation strategy (self-collected lab specimens from home and telehealth follow-up) to standard of care (SOC) at the Public Health-Seattle \& King County (PHSKC) Sexual Health Clinic (SHC). The study's primary outcome will be effectiveness of the implementation strategy measured as the rate of retention in PrEP care. In secondary analyses, investigators will utilize mixed methods to assess reach (proportion of persons offered HB-PrEP who choose to use it), and examine individual-level barriers and facilitators (B\&F) to PrEP retention (participant surveys and interviews) and system-level B\&F to HB-PrEP implementation (participant surveys and interviews, PHSKC staff interviews). Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits.
- AIM 2: Perform a cost analysis of HB-PrEP service implementation at the PHSKC SHC compared to SOC. Investigators will track resource use and prospectively collect unit costs for laboratory fees, healthcare worker time and other clinic resources to estimate the total monthly cost of providing HB-PrEP services overall and the monthly cost per person retained in PrEP care in the HB-PrEP and SOC arms. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC.
- AIM 3: Conduct a HB-PrEP scale-up assessment with healthcare organizations (HCO) and other key stakeholders to determine the scalability of HB-PrEP within Washington State. To evaluate institution-level factors that may impede or facilitate statewide HB-PrEP scale-up, investigators will conduct semi-structured interviews with key stakeholders from a countywide EHE HCO collaborative.
The Aim 1 study is a pragmatic, non-blinded, hybrid type 1 (clinical-implementation) RCT and includes mixed-methods assessments to evaluate both qualitative and quantitative data for the primary and secondary outcomes. Aim 3 is a qualitative study using in-depth interviews.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patients will receive standard PrEP care in the clinic including in-person visits for triannual (every 4 months) HIV \& STI screening and comprehensive sexual health care. |
| Home-based care | Experimental | Other: Health service - home-based PrEP monitoringPatients will have the option to complete their PrEP care from home including 1) self-collection of blood specimens for HIV, syphilis and creatinine; 2) self-swabs for extragenital GC/CT screening; and 3) telehealth follow-up. A maximum of two triannual follow-up visits per year may be conducted remotely; one visit per year must be in person. Participants also have the option to attend visits in person and are otherwise eligible to continue receiving comprehensive sexual health services in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be eligible to receive PrEP per PHSKC criteria
- Age ≥18 years
- Washington State resident
- Ability to speak, understand and read/write in English or Spanish
- Willing to provide contact information
Key exclusion criteria (6 listed)
- Recent (<4 weeks) "high risk" HIV exposure while off PrEP or symptoms of acute HIV
- No mailing address to receive sampling kits
- No working telephone number
- No smartphone or other device with internet access
- History of a bleeding disorder, or current or recent (≤7 days) use of anticoagulant medications
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 |
|---|---|---|
| Health service - home-based PrEP monitoringHome-based PrEP care | Other | Home-based care |
Primary outcome
PrEP retention
Time frame: 18 months
Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription
7 secondary outcomes
Reach
Time frame: 18 months
User satisfaction
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
PrEP adherence
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
Time to action on abnormal results
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
STI positivity rate
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
Barriers and facilitators of PrEP retention
Time frame: Every 4 months starting at month 4 until target of 24 reached
Cost
Time frame: Month 12 through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 35562692Cannon CA, Ramchandani MS, Golden MR. Feasibility of a novel self-collection method for blood samples and its acceptability for future home-based PrEP monitoring. BMC Infect Dis. 2022 May 13;22(1):459. doi: 10.1186/s12879-022-07432-0.
- Derived from this study: PubMed 39312771Cannon C, Holzhauer K, Golden M. Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 23;13:e56587. doi: 10.2196/56587.
Related trials for HIV Prevention
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
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. This study is not recruiting at the moment.
Chase Cannon, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health service - home-based PrEP monitoring in people with HIV Prevention and Pre-exposure Prophylaxis, run by University of Washington 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chase Cannon, MD, MPH (206-744-4393, ccannon5@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP retention (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05856942, which also lists 2 linked publications.
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 10 May 2024.