Holistic Care, Universal First-Line HIV ART Speed Care

UPDATED October 29, 2020 // Editor's Note: In light of additional information provided by Boston Medical Center, a misleading headline was rewritten, and enrollment procedures for the DAART program, which was mistakenly described as a study, have been clarified.

Time to enrollment in HIV treatment dropped by 53% when clinicians sent treatment-naive patients home from intake with a bottle of universal first-line therapy. This was before seeing a physician.

Adding immediate antiretroviral treatment (ART) initiation to a comprehensive, team-based HIV program treats HIV like the chronic condition it is and reduces stigma that can be a barrier to care, said Glory Ruiz, MD, public health programs director at Boston Medical Center (BMC).

Dr Glory Ruiz

"The patients are in such good shape when they leave from that same-day ART initiation that by the time they get to the first MD visit, they're already doing better," Ruiz told Medscape Medical News during the virtual United States Conference on HIV/AIDS 2020 (USCHA 2020). "The doctors are able to confidently say, 'I don't need to see you in 4 months.' "

Instead, they meet with an MD at 6 months. Meanwhile, they receive wrap-around services from BMC's Center for Infectious Diseases clinic staff. This is helpful because most of the clinic's patients are covered by Medicare or Medicaid and have multiple competing priorities, such as housing, transportation, insurance navigation, and immigration support.

Still, the results represent just 61% of patients in a small cohort that was complicated by the coronavirus pandemic, which altered approaches to care. But Ruiz said the findings show that immediate ART is a great tool to add to the HIV care toolbox when clinics can support their patients' other needs too.

"It is generalizable for clinics that look like ours," she said. "Clinics could leverage clinicians, the pharmacy, and case management resources to provide this tool for patients."

A Backbone for Rapid ART

Before launching the Direct Access to Anti-Retroviral Therapy (DAART) program, average enrollment in care took more than 2 weeks — which was better than the US Centers for Disease Control and Prevention goal of 30 days but higher than Ruiz and the team wanted.

So they went back to their community and asked patients, clinicians, care navigators, sexually transmitted infection counselors, and outreach workers what the hold-ups were in their linkage-to-care program. They also conducted a literature review of other so-called red-carpet programs that could provide best practices. One of the main barriers they identified was the diversity in how clinic providers prescribed ART. Some prescribed the same day. Others waited for genotyping of the patient's virus to come back.

They realized they'd need to standardize ART initiation. So they went back to the pharmacy and reviewed viral suppression data for the clinic's 1600 patients, focusing on genotypic profile.

What they found was that the HIV in their area responded best to a combination of bictegravir, emtracitabine and tenofovir alafenamide (Biktarvy), which became the their first-line option. The alternative was darunavir and cobicistat with emtracitabine and tenofovir alafenamide, sold as a single pill called Symtuza.

Then they performed a chart review to see who might qualify for the program and offered it to them. In the process, they were also conducting general intake for the patients, which included a review of the Massachusetts Department of Public Health's acuity scale and linking patients to the immigration, transportation, housing, and other support that could underpin medical care.

Findings, Interrupted

In February 2019, DAART rolled out. Since then, 61 patients have qualified for DAART, meaning they were treatment naive — either newly diagnosed or with a known HIV diagnosis with no history of treatment and co-occurring injection drug use or otherwise at high risk for transmitting the virus.

People with treatment experience were ineligible for DAART, as were those with renal insufficiency or coinfections such as active central nervous system opportunistic infections.

Of the 61 people eligible, 37 (61%) were enrolled in DAART. That number also accounts for 45% of people newly diagnosed with HIV at Boston Medical Center during that time.

"The reasons the other patients haven't been enrolled but are eligible is because they came in through the ED, have been admitted, and then leave [against medical advice] before we're able to get to them," said Katy Scrudder, MPH, a data quality specialist at BMC. "Another big reason for patients not entering is because they have other comorbidities that are needing to be addressed first. A big one for this population is mental health crises."

Those who weren't enrolled in DAART initially were linked to other care and were checked on periodically to see how they were doing. Since then, 85% of those who elected not to start ART right away are in HIV treatment, too, Diaz said.

Of the 37 patients who elected to start ART immediately — and for whom there are enough data to assess follow-up — 36 were durably engaged in care and taking medication in October 2020, according to data shared with Medscape Medical News. The team defined engagement in care as having had at least one follow-up appointment with the physician, and potentially two. Because the program is not yet 2 years old and because COVID-19 paused and then changed how the team worked with people eligible for DAART, the team is awaiting more data to see how outcomes evolve.

None of the original 36 DAART patients have developed treatment-resistant mutations.

Ruiz attributed the strong ongoing engagement in care to the intake team, which reflects the communities they serve at the hospital — the majority are people of color, 20% are in recovery for alcohol or drugs, 5% are living with HIV, the staff speak a combined total of eight languages, and many are from the immigrant communities that most frequent BMC.

And, she added, it's likely because handing medications to a patient the day of intake puts HIV into the chronic disease category where it belongs.

"If you have diabetes or hypertension, we're going to prescribe you medicine — and if we need to titrer it along the way, we will titer it along the way," she said. In DAART, they do the same with HIV. "It helps the patient feel better and cope with the new diagnosis."

No Pill for Will

The single original patient not receiving ART is engaged in care with their primary care provider. But according to Ruiz, the patient "refuses to engage in any conversations about his HIV care and refuses to accept any HIV prescriptions."

This is where the patient-centered approach at the clinic becomes essential, Ruiz said. The multidisciplinary nature of the clinic includes clinicians expert in refugee healthcare and care navigators who accompany patients to the pharmacy, go to pick up the medications for the patient, or walk them through insurance navigation.

Larry Scott-Walker

But that one case represents a truth that clinicians can struggle with: It's not always a patient's goal to get to viral suppression, and even if it is, some patients will never get there, said Larry Scott-Walker, cofounder and executive director of the HIV service organization Thrive SS, in Atlanta, Georgia.

To battle stigma, clinicians need to put the patient's goals ahead of their own goals for viral suppression.

"Clinicians are trained to focus on viral suppression, but there's a science to engaging with a patient in a way that empowers them," he told Medscape Medical News. He pointed to motivational interviewing and to the conversations he has with his colleague Leisha McKinley-Beach, an HIV consultant. They may not talk at all about HIV in their 15-minute discussions, but they leave him feeling motivated to "eat a bowl of broccoli and take my ARVs."

As he put it in another USCHA 2020 presentation, there is no pill to increase a person's will.

"My whole life matters," not just his viral load, Scott-Walker said. "We providers have to train ourselves not to hinge everything on a pill, a magical pill, because the truth is that there could be a cure to HIV, and some people will not get it because of how valued vs. devalued they feel."

Ruiz agreed.

"It's important that we make sure our team reflects the population we serve," she said. "And it's why it's important to do everything we possibly can to make that human connection very early on in the process."

United States Conference on HIV/AIDS: Workshop Session 4: AART Program Evaluation: Solutions to Barriers in Rapid HIV Treatment. Workshop Session 4: Viremia, Vulnerability and Victory: The Black experience living with HIV. Presented October21, 2020.

Heather Boerner is a science and medical reporter based in Pittsburgh, Pennsylvania.

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