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Home-Based PrEP Monitoring for HIV Prevention (HOT4PrEP Trial)
N/A
Recruiting
Led By Chase Cannon, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 months up to 16 months and at study exit (on/after 18 months)
Awards & highlights
HOT4PrEP Trial Summary
This trial will assess a home-based PrEP monitoring system to improve PrEP retention and analyze the costs & scalability of the program.
Who is the study for?
This trial is for adults over 18 living in Washington State who meet the criteria to receive PrEP, a medication that helps prevent HIV. Participants must speak English or Spanish and be willing to share contact information and follow study procedures.Check my eligibility
What is being tested?
The study tests a home-based system for monitoring PrEP use, involving self-collected blood samples and telehealth check-ups. It compares this method with standard clinic visits to see if it improves how long people stay on PrEP.See study design
What are the potential side effects?
Since the intervention involves health services rather than medications, side effects are not typical as with drug trials. However, discomfort from self-collection of blood samples using Tasso devices may occur.
HOT4PrEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 months up to 16 months and at study exit (on/after 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 months up to 16 months and at study exit (on/after 18 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PrEP retention
Secondary outcome measures
Barriers and facilitators of PrEP retention
Cost
PrEP adherence
+4 moreHOT4PrEP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based careExperimental Treatment1 Intervention
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.
Group II: Standard careActive Control1 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.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,308 Total Patients Enrolled
3 Trials studying Pre-Exposure Prophylaxis
8,082 Patients Enrolled for Pre-Exposure Prophylaxis
Tasso Inc.Industry Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
Chase Cannon, MD, MPHPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a working phone.I have a bleeding disorder or have used blood thinners in the last week.I was recently exposed to HIV and was not on PrEP.I am 18 years old or older.I am eligible for HIV prevention medication according to health guidelines.I can speak, understand, and read/write in English or Spanish.I am willing to follow the study's procedures and accept random assignment.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based care
- Group 2: Standard care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there presently any openings in this trial for prospective participants?
"Yes, the clinical trial is still looking for volunteers. The listing was initially made on March 8th 2022 and most recently modified on May 3rd 2023, as evidenced by its entry in the records of ClinicalTrials.gov."
Answered by AI
To what capacity is the clinical trial recruiting participants?
"Affirmative. Clinicaltrials.gov's data confirms that this clinical trial, which was first posted on March 8th 2022, is still in search of participants. It requires 458 patients from a single medical site to complete the trial."
Answered by AI
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