CATIE News

24 July 2018 

A pilot study of home-based PrEP monitoring

  • PrEP users require regular visits to a clinic to test for HIV, STIs and kidney health.
  • U.S. researchers piloted self-administered tests in place of in-person appointments.
  • 93% of participants were able to renew their prescription without seeing a doctor.

One option to reduce the chances of becoming infected with HIV during sex includes taking a pill containing two anti-HIV medicines—tenofovir DF + FTC. This pill is sold under the brand name Truvada and also comes in generic formulations. Clinical trials have found that the daily use of these drugs, together with other measures, is highly effective at reducing the risk of HIV infection. The use of medicines prior to potential exposure is called pre-exposure prophylaxis (PrEP).

Before PrEP is prescribed to someone, they have to visit a doctor and a lab to be sure that they do not have HIV or other sexually transmitted infections (STIs). After prescription of PrEP, regular (quarterly) visits to a doctor and lab are needed to screen for HIV and other STIs and monitor for any side effects.

People who are prescribed PrEP are generally healthy and may not be used to the need for ongoing medical and laboratory monitoring that accompanies PrEP. Such visits may take people away from work, particularly if clinics and labs are only open during the daytime. Furthermore, even if one has an appointment, there is usually some time spent in a clinic’s waiting room. All of these issues involving time can act as barriers to keeping people engaged with PrEP.

In an attempt to chart a course to overcome such barriers, a team of U.S. researchers in Boston, San Francisco and St. Louis collaborated in a pilot study of what they called “PrEP@Home,” which they described as follows: “A system of remote laboratory and behavioural monitoring designed to replace routine quarterly follow-up visits with home care to reduce the patient and provider burden.”

Results from a pilot study with 57 people, in press in the journal Clinical Infectious Diseases, are very encouraging. The researchers are now in the process of launching a larger randomized study to confirm their results.

Study details

Researchers sought men who fit the following criteria:

  • had anal sex with at least one male partner in the past year
  • had been prescribed and were taking PrEP
  • did not feel faint at the sight of blood

The average profile of participants upon entering the study was as follows:

  • age – 31 years
  • major ethno-racial groups: white – 55%; black – 22%; Asian – 11%; Hispanic – 9%
  • 60% had been taking PrEP for less than one year
  • 75% reported that they had not missed any doses of PrEP in the past week

The intervention

PrEP@Home was designed to replace one of the quarterly in-person clinic and lab appointments recommended by guidelines. Participants in the study received what the researchers described as a “discreet box” several weeks prior to their next scheduled clinic visit. The box contained instructions about how to collect specimens (described later in this report). These instructions were supplemented by a video. The instructions for collection of specimens were developed based on user feedback from an earlier project. In addition, if participants encountered problems they were given access to a 24-hour toll-free help line.

Participants self-collected the following:

  • rectal and throat swabs
  • urine sample
  • a small amount of blood via a finger prick

The urine and swabs were tested for chlamydia and gonorrhea and the blood was tested for HIV and to assess kidney health.

Participants were provided with a pre-paid package for sending specimens to a lab.

Participants completed online behavioural surveys that asked about the following:

  • drug side effects
  • HIV risk behaviours
  • possible symptoms of STIs (including acute HIV infection)
  • adherence to PrEP

Note that physicians prescribed PrEP to be taken daily.

Results

One participant stopped communicating with the study team and two others left the study and went into regular PrEP care because of difficulty collecting blood samples.

None of the participants tested positive for HIV or syphilis.

Results of the swabs and urine tests were as follows:

Chlamydia

  • in the rectum – 13%
  • in the urethra – 7%
  • in the throat – 0%

Gonorrhea

  • in the rectum – 4%
  • in the urethra – 0%
  • in the throat – 4%

The study was not designed to assess STI treatment, but most of the doctors who participated in the study disclosed that they treated patients with STIs according to U.S. guidelines.

The majority (93%) of men were able to have their prescriptions for PrEP renewed without the need to see a physician.

Experiences

Overall, participants rated their experience with PrEP@Home as “good.” Furthermore, researchers stated that “more than 85% of participants indicated that if a kit were available, they would use PrEP@Home in place of a standard visit [with a clinician and/or lab] within the following year.” The researchers also stated that “40% of participants reported that they would be more likely to persist in care if PrEP@Home were available.” These figures point to the ease of use and convenience that the study kit provides. It also points to the potential of the kit to keep people engaged in a highly effective way of preventing HIV infection.

Bear in mind

The present study was relatively small and cross-sectional in design. It is possible that the study was biased in that it recruited participants who wanted access to the PrEP@Home kit, and so ratings of their experience were high.

Balancing the impact on the healthcare system

The researchers stated that “PrEP is an extraordinarily promising intervention, but quarterly monitoring assessments place a burden on patients and the healthcare system….” The U.S. Centers for Disease Control and Prevention (CDC) estimates that more than 1.2 million people in the U.S. could benefit from PrEP. However, the study researchers noted, “the healthcare system would be burdened with nearly five million visits annually if PrEP were brought up to scale.”

Larger studies to start shortly

One of the researchers of the present study, Aaron Siegler, PhD, associate professor at Emory University, told CATIE News that a randomized clinical trial recruiting gay, bisexual and other men who have sex with men (MSM) for a larger study will begin in the next several months in the following U.S. cities:

  • Atlanta, Georgia
  • Boston, Massachusetts
  • Jackson, Mississippi
  • St. Louis, Missouri

This trial will explore the uptake and acceptability of PrEP@Home in about 400 young men. It will also assess levels of tenofovir in blood samples. This study is funded by the U.S. National Institutes of Mental Health (NIMH) and each participant is expected to stay in it for one year.

Dr. Siegler also said that he and his colleagues are planning another study, which will begin recruitment in early autumn 2018, called “ePrEP” that is based on a smartphone application (an “app”).  The app makes available a secure messaging platform and a secure video so participants can contact the study physicians. The purpose of ePrEP is to try to reduce the need for an in-person visit to a healthcare provider by making electronic access to providers available instead. This study will be tested in rural areas of the U.S., where doctors highly experienced with PrEP are not easy to find and patients sometimes have to travel large distances to see them.

Embracing and integrating technology in health

In closing their report on the present study, researchers made the following statement:

“Technological advances in high-speed connectivity, smartphones and laboratory testing are changing the landscape in which care can be delivered. Future research should explore how to leverage such changes toward decreasing health disparities.”

This forward-looking statement signals exciting possibilities that will likely occur over the coming decade. People who have access to and who can and want to make in-person visits to their doctor or nurse will continue to do so, but more options to access healthcare will likely be pilot-tested in the years ahead and should eventually become reality so that more people can receive health services in a way that is convenient for them.

PrEP resources

Oral pre-exposure prophylaxis (PrEP) – CATIE fact sheet

CATIE statement on the use of oral pre-exposure prophylaxis (PrEP) as a highly effective strategy to prevent the sexual transmission of HIV

Canadian guideline on HIV pre-exposure prophylaxis and nonoccupational post-exposure prophylaxis

8 Questions About PrEP for Guys – CATIE

La prophylaxie préexposition au virus de l'immunodéficience humaine : Guide pour les professionnels de la santé du Québec – Ministère de la Santé et des Services sociaux du Québec (French only)

Guidance for the use of Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV acquisition in British Columbia – BC Centre for Excellence in HIV/AIDS

Pre-exposure prophylaxis (PrEP) resources

—Sean R. Hosein

REFERENCES:

  1. Siegler AJ, Mayer KH, Liu AY, et al. Developing and assessing the feasibility of a home-based PrEP monitoring and support program. Clinical Infectious Diseases. 2018; in press.
  2. Jauhar S. “The patient will see you now” by Eric Topol. New York Times. 13 February 2015. Available at: https://www.nytimes.com/2015/02/15/books/review/the-patient-will-see-you-now-by-eric-topol.html