Home-Based PrEP Monitoring for HIV Prevention

(HOT4PrEP Trial)

Overseen By Chase Cannon, MD, MPH

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. ^{1 2 3 4 5}

Is 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. ^{2 5 6 7 8}

How 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. ^{6 9 10 11 12}

Research Team

Chase Cannon, MD, MPH

Principal Investigator

University of Washington

Eligibility 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

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

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

Treatment Details

Interventions

• Home-based PrEP Monitoring (Behavioural Intervention)

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.

Participant Groups

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.

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Daily short message service surveys to measure sexual behavior and pre-exposure prophylaxis use among Kenyan men and women. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program. [2022]

4. United States 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. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

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

6. Netherlands 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. [2022]

7. Canada 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Challenges and opportunities for oral pre-exposure prophylaxis in the prevention of HIV infection: where are we in Europe? [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV in Primary Care and Beyond. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. [2020]

12. Switzerland 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. [2022]