Good solutions have great roadmaps.
For HIV preexposure prophylaxis (PrEP), the road map might just be that of contraceptive care. Once an onerous process, over time contraceptive care exploded into a range of options across a broad landscape in terms of approach and accessibility.
How then do organizations help vulnerable patients navigate their PrEP journeys using the contraceptive roadmap as a guide?
That's what researchers at the University of Washington were intent on demonstrating, according to Julie Dombrowski, MD, MPH, an infectious disease specialist at the University of Washington School of Medicine and deputy director of the HIV/STD Program, Public Health for the city of Seattle and King County, Washington.
"The same sorts of things that happened with oral contraceptive pills — which initially required you to see a gynecologist and get a Pap smear — over time, became much more available," said Dombrowski, co-author of a new study published online in the Journal of Acquired Immune Deficiency Syndrome.
"The basic idea is that PrEP is not medically complicated; it can be easily protocolized," she told Medscape Medical News.
Decentralizing HIV PrEP
In addition to her responsibilities at University of Washington-Seattle, Dombrowski provides clinical services at the Public Health Sexual Health Clinic (PHSKC) at Seattle's Harborview Medical Center — a dual-county center that provides confidential STI and HIV evaluation, screening, testing, and treatment on a walk-in basis for a sliding fee.
Sexual health clinics are ideal environments for reaching large numbers of patients, but strategies for integrating PrEP successfully into what are commonly one-time appointments have not been well-described or broadly adopted.
"Sexual health clinics in general are STD specialty clinics with walk-in access to care; often, patients come into a clinic, get seen, diagnosed, and treated, and they don't necessarily come back," said Dombrowski.
She said that because most operations have been set up around same-day treatment, to offer PrEP and successfully change outcomes, there needs to be a shift in the current model toward one that promotes an ongoing relationship with the patients.
So, she and her colleagues decided to see what would happen if they implemented a decentralized PrEP model in their clinic over a 6-year period. They established a protocol that moves from an initial consultation with a clinician to review risk behaviors, ascertain HIV status, and acquire a PrEP prescription, to ongoing interactions with an STI and PrEP-trained disease intervention specialist (DIS).
As the clinic's PrEP program coordinators, these specialists enroll patients in PrEP drug assistance programs, verify prescription fills, provide follow-up visits and adherence and adverse events assessments, and collect specimens.
"[Disease intervention specialists] are frontline public health workers who ensure that people diagnosed with HIV or an STI — or who've been exposed — get necessary testing and treatment," explained Dombrowski. "They're very similar to patient navigators."
At the same time, clinicians remain the key providers for annual appointments, new symptoms, STI diagnoses, adverse drug reactions, and missed doses. Licensed medical providers review all labs.
Shifting Responsibilities, Better PrEP Initiation, Retention Rates
After establishing the PrEP services protocol, the University of Washington team then assessed retention rates among PrEP patients who attended an initial visit (1387) from October 2014–December 2019. Follow-up continued through February 2020. (For study purposes, PrEP discontinuation was defined as either stopping PrEP after initiation or as lost to follow-up, ie, either not attending a follow-up visit or not responding to more than three DIS calls or text messages).
Just over half of the participants were aged 20-29 years, and a third were aged 30-39. More than 9 out of 10 (93%) were men who sleep with men (MSM), 55% white, 26% Hispanic/Latinx, and 10% Black.
Over the course of the study, 6887 PrEP visits were recorded. Quarterly visits increased concurrently with the program expansion, from 31 visits in 2014 to 623 in the fourth quarter (Q4) of 2019. Likewise, while 57% of visits overall were with a clinician, DIS visits increased from 3% in Q4 of 2014 to 45% in Q4 of 2019, an increase of 1400% in 5 years.
Significant numbers of patients also initiated PrEP in the clinic, especially when prescribing practices were expanded to be part of routine, walk-in visits.
Retention rates also improved, with 43% (510/1190) of patients still on PrEP at the end of the analysis period. Forty-one percent (490) discontinued PrEP, 21% within 3 months of initiation, and 72% within a year; another 16% moved, transferred care, or tested positive, and were considered "censored." However, as of July 31, 2021, 54% (265) of the 490 patients who had discontinued PrEP returned to the clinic for a restart visit, 93% of whom refilled their restart prescription.
"This is really basic preventative care and is actually quite easy to do," noted Sarah Schmalzle, MD, assistant professor of medicine and medical director of the Thrive Program at the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore. Schmalzle was not involved in the study.
Schmalzle practices in inner-city Baltimore, so she and her colleagues have been thorough in terms of setting up PrEP (and post-exposure prophylaxis, PEP) programs to ensure that patients access PrEP wherever they want to. But she also said that PrEP is only a part of the sexual wellness and prevention toolbox, and ideally, part of a whole prevention program.
"Focusing on how to get the prescription out is great but the rest is having ongoing and accurate sexual health conversations, healthy conversations about sex and prevention, to have [an] algorithm in place that says, 'here's your PrEP, this is the next time that you need an appointment, the next time you need labs, I'm going to check your adherence, etc.' "
Both Dombrowski and Schmalzle emphasized that decentralization is not a one-size model; flexibility is key, especially when it comes to who is providing PrEP
"People overcomplicate PrEP and clinicians do this too," said Dombrowski. "If we are going to successfully increase PrEP and improve the patient experience, we need to decrease the requirement for clinician involvement."
Dombrowski has disclosed no relevant financial relationships. Schmalzle receives grant funding from Gilead Sciences.
J Acquir Immune Defic Syndr. Published online April 29, 2022. Abstract
Liz Scherer is an independent journalist specializing in HIV and infectious diseases, cannabinoid therapeutics, oncology, and women's health. On Twitter @LizScherer
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Image 1: University of Washington School of Medicine
Image 2: Institute of Human Virology, University of Maryland School of Medicine
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Cite this: Decentralizing PrEP Offers a Roadmap for Retention - Medscape - May 10, 2022.