Home-Based PrEP Monitoring for HIV Prevention

(HOT4PrEP Trial)

Overseen By Chase Cannon, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: PrEP

Must not be taking: Anticoagulants

Disqualifiers: Recent HIV exposure, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

458 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring PrEP, a medication that helps prevent HIV. Participants can collect blood and swab samples at home and have follow-ups through telehealth, eliminating the need for clinic visits. The trial aims to determine if this home-based approach, known as Home-based PrEP Monitoring (HB-PrEP), improves adherence to PrEP routines compared to traditional in-clinic visits and assesses its cost-effectiveness. Individuals taking PrEP and residing in Washington State may be suitable for this trial, particularly if they prefer or require more flexible healthcare options. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions that prioritize convenience and flexibility.

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 prior data suggests that this home-based PrEP monitoring system is safe?

Research shows that monitoring PrEP (pre-exposure prophylaxis) at home is a promising way to prevent HIV. This involves collecting blood samples independently and attending follow-up appointments through telehealth. Past studies have used these methods safely and effectively. For example, self-collection kits like Tasso devices, which function like small medical lancets, have proven easy to use.

No major problems have been reported with this method. Research indicates that individuals using home-based care for PrEP tend to adhere to their prevention plans without facing significant issues. Additionally, no serious kidney problems have been linked to this type of PrEP care.

Overall, evidence suggests that home-based PrEP monitoring is safe. Participants in previous studies successfully collected their own samples and utilized telehealth support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home-based PrEP monitoring for HIV prevention because it offers a convenient alternative to traditional in-clinic visits. Unlike standard care, which requires frequent in-person visits for screenings and follow-ups, this approach allows patients to manage much of their PrEP care from home. Key features include self-collection of blood specimens and self-swabs for STI screening, along with telehealth follow-ups, which significantly reduce the need for clinic visits. This could lead to improved adherence to PrEP regimens and make preventive care more accessible for individuals with busy schedules or limited access to healthcare facilities.

What evidence suggests that this home-based PrEP monitoring is effective for HIV prevention?

This trial will compare home-based PrEP monitoring (HB-PrEP) with standard clinic-based care. Research has shown that monitoring PrEP treatment at home can help people stay on their medication longer. In one study, this home-based approach increased the number of people who continued their treatment by over 10% compared to those who received care at a clinic. Another study found that telehealth services like PrEPTECH made accessing PrEP easier. Most people find HB-PrEP easy to use and acceptable, which helps them stick to their treatment. Early evidence suggests that HB-PrEP is a promising option for those who want to manage their PrEP treatment from home. ^{5 6 7 8 9}

Who Is on the Research Team?

Chase Cannon, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

Washington State resident

Willing to provide contact information

I am eligible for HIV prevention medication according to health guidelines.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Home-based PrEP Monitoring

Trial Overview 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.

How Is the Trial Designed?

Group I: Home-based care Experimental Treatment 1 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 care Active Control 1 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, 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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Tasso Inc.

Industry Sponsor

Trials

4

Recruited

800+

Published Research Related to This Trial

In a pilot evaluation involving 226 HIV-uninfected individuals in Kenya, 98% accepted HIV self-testing, indicating a high level of acceptability for this method.

Participants found self-testing easy to use (96.8%) and reported feeling empowered by it, which helped reduce anxiety related to waiting for clinic test results, suggesting it could be an effective strategy for routine HIV testing between PrEP refills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya. Ngure, K., Heffron, R., Mugo, N., et al.[2023]

HIV pre-exposure prophylaxis (PrEP) is a highly effective and safe antiretroviral medication that significantly reduces the risk of HIV infection in individuals at high risk due to sexual practices or intravenous drug use.

Despite its proven efficacy, PrEP remains underutilized in the U.S., and initial testing for HIV, hepatitis B, and renal function is necessary before starting treatment, with ongoing monitoring required for both approved oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV in Primary Care and Beyond. Drallmeier, T., Meyr, A.[2022]

In a study of 1201 pregnant women, 84% initiated PrEP at their first antenatal care visit, indicating high acceptance of this HIV prevention strategy during pregnancy.

However, only 58% of women continued PrEP after 3 months, with side effects like nausea affecting adherence, especially among those in their first and second trimesters, highlighting the need for targeted support and counseling for postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa. Joseph Davey, DL., Mvududu, R., Mashele, N., et al.[2022]

In a study involving 96 HIV-uninfected adults in Kenya, daily SMS surveys showed that 96.9% of participants adhered to taking PrEP on at least 80% of days, although 69.8% missed at least one dose.

Interestingly, unprotected sex was reported on only 4.9% of days and was not linked to lower PrEP adherence, suggesting that high adherence to PrEP can occur even among individuals who engage in unprotected sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily short message service surveys to measure sexual behavior and pre-exposure prophylaxis use among Kenyan men and women. Curran, K., Mugo, NR., Kurth, A., et al.[2022]

The PrEP@Home system, which allows for remote monitoring of preexposure prophylaxis (PrEP) for HIV prevention, was well-received by participants, indicating a strong demand for this approach.

Over one-third of participants expressed that they would be more likely to continue their care if the home-based system were available, suggesting it could improve adherence to PrEP treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program. Siegler, AJ., Mayer, KH., Liu, AY., et al.[2022]

In a study involving 3065 high-risk HIV-negative adults, the incidence of HIV-1 was very low at 1.1 cases per 1000 person-years, showing that both daily and on-demand PrEP are effective in preventing HIV infection.

There was no significant difference in HIV-1 incidence between those using daily PrEP and those using on-demand PrEP, indicating that on-demand PrEP is a valid alternative, providing flexibility for men who have sex with men (MSM) in their HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Molina, JM., Ghosn, J., Assoumou, L., et al.[2022]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

This study aims to evaluate the effectiveness of a home-based PrEP care intervention (ePrEP) using a mobile app and self-collection kits for young men who have sex with men (YMSM) in rural areas, targeting improved initiation and persistence in PrEP care.

The trial will compare the ePrEP intervention to standard care, with the primary outcome being the proportion of participants achieving protective levels of the PrEP metabolite at 6 and 12 months, potentially demonstrating a new way to increase access to HIV prevention in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Siegler, AJ., Brock, JB., Hurt, CB., et al.[2020]

Daily oral tenofovir and emtricitabine, approved for pre-exposure prophylaxis (PrEP) to prevent HIV, presents both challenges and opportunities for implementation, especially among high-risk groups like men who have sex with men.

Key considerations for effective PrEP use include evaluating its real-world effectiveness, ensuring sustainable adherence, monitoring long-term safety, and understanding potential changes in sexual behavior that could impact its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and opportunities for oral pre-exposure prophylaxis in the prevention of HIV infection: where are we in Europe? Molina, JM., Pintado, C., Gatey, C., et al.[2021]

A study involving 495 participants in Kenya found that semiannual PrEP dispensing combined with interim home-based HIV self-testing (HIVST) was as effective as standard care in maintaining HIV testing, drug refilling, and adherence among users.

No participants acquired HIV during the study, indicating that the new approach of reducing clinic visits did not compromise safety or efficacy in preventing HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. Ngure, K., Ortblad, KF., Mogere, P., et al.[2023]

In the MTN-020/ASPIRE trial, which tested the dapivirine intravaginal ring for HIV-1 prevention, a real-time adherence monitoring system was successfully implemented, showing that adherence to the product improved significantly over time, from 63% to 84% of participants using the product effectively.

The study demonstrated that ongoing drug level testing can be a feasible method for monitoring adherence in clinical trials without unblinding participants, which is crucial for ensuring the effectiveness of preventive treatments like PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. Husnik, MJ., Brown, ER., Marzinke, M., et al.[2020]

Home-based service delivery effectively improved access to pre-exposure prophylaxis (PrEP) for HIV among adolescent girls and young women in Eastern Cape, South Africa, as it provided trusted information and involved family in decision-making.

Participants who initiated PrEP felt they were at a higher risk for HIV, suggesting that integrating home-based HIV testing with PrEP education could help reduce barriers and increase PrEP uptake in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mudzingwa, EK., de Vos, L., Atujuna, M., et al.[2023]

Citations

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Effectiveness of PrEPTECH: Findings From a 180-Day ... This randomized controlled trial of PrEPTECH, a telehealth intervention for the provision of HIV PrEP, seeks to assess its effects on PrEP access.

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7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2806098

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing ... This randomized noninferiority trial evaluated whether 6-month preexposure prophylaxis (PrEP) dispensing, supported by interim HIV ...

8. hivguidelines.org hivguidelines.org/guideline/hiv-prep/

PrEP to Prevent HIV and Promote Sexual Health A modeling analysis projected that structured choice, including the option of CAB LA, could reduce HIV incidence by one-third over 10 years and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1201971225003881

Evaluating PrEP Rapid Engagement and Same-Day Start ... Same-day PrEP initiation achieved 92% uptake within 24 hours. ... Retention at 12 months was 63%, double historical norms. ... No serious renal ...