Home-Based PrEP Monitoring for HIV Prevention
(HOT4PrEP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Must be taking: PrEP
Must not be taking: Anticoagulants
Disqualifiers: Recent HIV exposure, Bleeding disorder, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used anticoagulant medications in the past 7 days.
What data supports the effectiveness of the treatment Home-based PrEP Monitoring for HIV Prevention?
Research shows that home-based PrEP monitoring, like PrEP@Home, is highly acceptable and can encourage people to continue their care. Additionally, integrating home-based HIV testing with PrEP education can help increase PrEP uptake by reducing barriers and involving family support.
12345Is Home-Based PrEP Monitoring safe for humans?
The research articles do not provide specific safety data for Home-Based PrEP Monitoring, but they discuss the safety of PrEP (pre-exposure prophylaxis) in general, which is used for HIV prevention. PrEP has been shown to be effective and generally safe when taken as prescribed, although long-term safety and adherence are important considerations.
25678How is the Home-based PrEP Monitoring treatment different from other HIV prevention treatments?
Home-based PrEP Monitoring is unique because it allows individuals to monitor their HIV prevention treatment at home, potentially increasing convenience and adherence compared to traditional clinic-based monitoring.
69101112Eligibility Criteria
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.Inclusion Criteria
I am 18 years old or older.
I am eligible for HIV prevention medication according to health guidelines.
Washington State resident
+3 more
Exclusion Criteria
I do not have a working phone.
I have a bleeding disorder or have used blood thinners in the last week.
No mailing address to receive sampling kits
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Home-based PrEP Monitoring
Participants self-collect blood and extragenital specimens at home and have telehealth follow-up
18 months
Maximum of 2 remote visits per year, 1 in-person visit per year
Standard Care
Participants receive standard PrEP care in the clinic with in-person visits for triannual HIV & STI screening
18 months
Triannual in-person visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Participant Groups
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.
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.
Home-based PrEP Monitoring is already approved in United States, United States, European Union for the following indications:
🇺🇸 Approved in United States as Truvada (TDF/FTC) for:
- HIV Pre-exposure Prophylaxis
🇺🇸 Approved in United States as Descovy (TAF/FTC) for:
- HIV Pre-exposure Prophylaxis for cisgender men who have sex with men and transgender women
🇪🇺 Approved in European Union as Truvada (TDF/FTC) for:
- HIV Pre-exposure Prophylaxis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashingtonSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
Tasso Inc.Industry Sponsor
References
Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. [2023]Oral pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective and is being implemented at scale at health clinics throughout sub-Saharan Africa. However, barriers to clinic-based PrEP delivery remain. We aimed to establish the efficiency of semiannual PrEP clinic visits supplemented with interim home-based HIV self-testing (HIVST) versus standard of care for HIV testing, drug refilling, and adherence among PrEP users.
Daily short message service surveys to measure sexual behavior and pre-exposure prophylaxis use among Kenyan men and women. [2022]Pre-exposure prophylaxis (PrEP) is a novel HIV prevention strategy which requires high adherence. We tested the use of daily short message service (i.e., SMS/text message) surveys to measure sexual behavior and PrEP adherence in Kenya. Ninety-six HIV-uninfected adult individuals, taking daily oral PrEP in a clinical trial, received daily SMS surveys for 60 days. Most participants (96.9 %) reported taking PrEP on ≥80 % days, but 69.8 % missed at least one dose. Unprotected sex was reported on 4.9 % of days; however, 47.9 % of participants reported unprotected sex at least once. Unprotected sex was not correlated with PrEP use (OR = 0.95). Participants reporting more sex were less likely to report PrEP non-adherence and those reporting no sex were most likely to report missing a PrEP dose (adjusted OR = 1.87). PrEP adherence was high, missed doses were correlated with sexual abstinence, and unprotected sex was not associated with decreased PrEP adherence.
Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program. [2022]We piloted PrEP@Home, a preexposure prophylaxis system of remote laboratory and behavioral monitoring designed to replace routine quarterly follow-up visits with home care to reduce the patient and provider burden. The system was highly acceptable and in-demand for future use, and more than one-third of participants reported greater likelihood of persisting in care if available.
Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study. [2023]Home-based service delivery has been used to improve access to HIV testing and antiretroviral initiation across sub-Saharan Africa, but it has yet to be leveraged to improve pre-exposure prophylaxis (PrEP) uptake. We interviewed 37 adolescent girls and young women (AGYW) in Eastern Cape, South Africa to explore why they chose to initiate PrEP or not following home-based HIV testing and referral for PrEP, and what influenced time to PrEP initiation. Participants reported that home visits provided a source of trusted information and a way to involve family members in their PrEP initiation decisions, motivating some to start PrEP. AGYW who initiated PrEP were more likely to qualitatively perceive themselves to be at high risk for HIV compared with those who never initiated PrEP. Integrating home-based HIV testing with PrEP education and referral may be a valuable way to reduce familial barriers and boost PrEP uptake among AGYW in South Africa. Trial registration: NCT03977181. Retrospectively registered on June 6, 2019.
A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. [2019]Background Pre-exposure prophylaxis, or PrEP, has been shown to be effective at reducing the risk of HIV infection, yet persons at-risk for acquiring HIV exhibit suboptimal uptake of and adherence to this prevention modality. Although PrEP use among all at-risk groups is low, mobile apps have been shown to increase the use of PrEP; however, it is unknown whether currently available apps have been designed with features to facilitate PrEP uptake and adherence.
Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. [2022]There are few data available regarding the use of on-demand pre-exposure prophylaxis (PrEP) for HIV prevention. We aimed to assess PrEP effectiveness, adherence, and safety in adults using daily or on-demand PrEP.
An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. [2020]Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care.
Challenges and opportunities for oral pre-exposure prophylaxis in the prevention of HIV infection: where are we in Europe? [2021]Following US Food and Drugs Administration approval in July 2012 of daily oral tenofovir and emtricitabine for pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk individuals in the USA, there has been much controversy about the implementation of this PrEP regimen in other countries throughout the world, and in Europe in particular. In this review, we focus on the challenges and opportunities of a daily oral PrEP regimen to curb the rising incidence of HIV infection in high-risk groups, and particularly in men who have sex with men. A number of issues would need to be addressed before PrEP could be implemented, including assessing the real effectiveness and cost-effectiveness of daily PrEP, the sustainability of daily adherence, the risk of selecting resistance, the long-term safety, and the risk of change in sexual behavior that might offset the benefit of PrEP. Alternatives to a daily oral PrEP regimen are being explored.
Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya. [2023]HIV testing is key to the delivery of pre-exposure prophylaxis (PrEP): testing HIV-uninfected at-risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost-effective HIV-testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high-risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self-testing.
Pre-Exposure Prophylaxis for HIV in Primary Care and Beyond. [2022]HIV pre-exposure prophylaxis (PrEP) is antiretroviral medication used to prevent HIV in patients at increased risk of acquisition due to sexual practices or intravenous drug use. Despite strong evidence of efficacy and safety, PrEP is currently underutilized in the United States. Initial testing includes HIV, hepatitis B, and renal function. There are currently two oral medications approved for daily use within the U.S.; regular monitoring for HIV and renal dysfunction is required with both medications.
Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. [2020]Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence.
Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa. [2022]Pre-exposure prophylaxis (PrEP) is a safe and effective prevention strategy to reduce women's risk of HIV in pregnancy and postpartum. Effective PrEP protection requires daily PrEP adherence, but little is known about maternal PrEP continuation and factors that influence PrEP use.