What side effects are associated with this type of intervention?

The most common treatments for Pre-Exposure Prophylaxis (PrEP), such as tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), are generally well-tolerated but can have side effects. Common side effects include gastrointestinal issues like nausea and diarrhea, headaches, and fatigue. Some individuals may experience mild kidney function changes or bone density loss, which are typically monitored through regular follow-ups. In the context of a home-based PrEP monitoring system, these side effects would still need to be tracked, but the convenience of remote monitoring and telehealth follow-up could help manage and mitigate these issues effectively.

What prior FDA approvals exist?

The FDA has approved several medications for Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, including Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide). These treatments are typically prescribed as part of a comprehensive HIV prevention strategy that includes regular HIV testing, adherence counseling, and risk-reduction practices. While traditional PrEP programs often require in-clinic visits for monitoring, the Home-Based PrEP (HB-PrEP) Monitoring System being studied aims to enhance retention and adherence by allowing patients to self-collect specimens at home and engage in telehealth follow-ups, potentially increasing accessibility and convenience for users.

What other types of research exist?

Promising, novel alternatives to Home-Based PrEP (HB-PrEP) Monitoring System for Pre-Exposure Prophylaxis patients in 2024 include: 1) AI-driven mobile health applications that provide personalized adherence reminders and real-time health monitoring. 2) Wearable devices that continuously monitor vital signs and medication adherence, transmitting data to healthcare providers. 3) Virtual reality (VR) platforms for patient education and engagement, enhancing understanding and adherence to PrEP regimens. 4) Blockchain-based systems for secure and transparent health data management, ensuring privacy and improving trust in remote monitoring solutions.

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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

No Placebo-Only Group

Summary

This trial tests a home-based system for HIV prevention where people collect their own blood samples and have online doctor visits. It aims to help at-risk groups, like people of color and younger MSM, by making it easier to stay on PrEP.

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.

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 months up to 16 months and at study exit (on/after 18 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PrEP retention

Secondary study objectives

Barriers and facilitators of PrEP retention

Cost

PrEP adherence

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pre-Exposure Prophylaxis (PrEP) include tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). These medications work by inhibiting the action of reverse transcriptase, an enzyme crucial for the replication of HIV. By preventing the virus from multiplying, these drugs significantly reduce the risk of HIV infection in individuals exposed to the virus. This is particularly important for PrEP patients using a home-based monitoring system, as it allows for consistent and effective prevention of HIV transmission while providing the convenience of remote monitoring and telehealth follow-up, thereby improving adherence and retention rates.

Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers.Efficacy and safety of antiviral therapy for HBV in different trimesters of pregnancy: systematic review and network meta-analysis.A randomized evaluation of on-site monitoring nested in a multinational randomized trial.