From testing to treatment: Opt-out model improves HIV outcomes in high-need settings
Despite advances in HIV prevention, underserved patient populations face disproportionate HIV rates and poorer health outcomes due to poverty, lack of access to healthcare, stigma and discrimination. In an oral abstract presentation at CROI 2026, Timothy Long, MD, chief clinical officer at Health Choice Network, a federally qualified community health center (FQHC), shared data from a study exploring how routine, opt-out HIV screening improved testing numbers for this population, and, importantly, linkage to care for people testing positive. The bottom line: interventions significantly boosted the number of people tested and successfully linked everyone diagnosed to care.
The observational cohort study, sponsored by Gilead Sciences, covered data from 2021–2024, collecting data from 13 FQHCs with the highest need and the highest positive rates, to assess the impact of the drugmaker’s FOCUS model, a public health initiative enabling partners to develop and share best practices in screening, diagnosis and linkage to care for HIV and hepatitis B and C.
The study covered four years, starting in the Miami-Dade area and expanding to 13 FQHCs including centers in New Mexico, Florida and Puerto Rico. These centers received FOCUS interventions, including not only routine testing, but better language services, help with payment and even mobile outreach for harder-to-reach people. Data on demographics, screening utilization and linkage outcome data were analyzed using multivariable logistic regression to determine which practices led to the greatest success.
Over that time 216,000 patients were screened using opt-out testing, which was something many providers in this network were initially apprehensive to do, Dr. Long said. With opt-out testing, people are automatically tested unless they specifically refuse the test. During that period, researchers identified 1,948 new cases of HIV, as well as 1,667 people who had already tested positive for HIV but were not engaged in care.
“All 100% of those that had a positive diagnosis were then linked into care or re-linked into care within one of our community health centers; 90% of them were linked within that first 30 days,” he said. “Getting people linked to care quickly was a challenge, because many of our patients were experiencing homelessness.”
But Dr. Long said some facilities had mobile clinics that met this population. A persistent and invested case management team going out on the street and offering ride shares was key to boosting not only testing but linkage to care, he added.
Payment was another hurdle: many FQHCs serve uninsured patients, up to 60% across Health Choice Network, while the rest are served by Medicaid and Medicare and, to a small degree, private insurance, according to Dr. Long.
Language was identified as a potential barrier to overcome. “Because we’re in South Florida, we did see a lot of Creole-speaking patients, and they had a higher predictive value to get tested,” he said. “And so many of the health centers that treat Creole-speaking patients have to have staff that create language-appropriate materials to help with those patients. The biggest cultural shift within the FQHC network, which took several years to overcome, was the move from risk-based testing to universal opt-out testing. But that shift had the biggest impact in the success of the study,” he said.
The initial conversation, usually by phone, if possible, is key to linking people to care. “I hired [a coordinator] who is empathetic and it’s the tone—that we’ll take care of you—in that initial conversation, that allows the linkage and the provider to have a more in-depth conversation.”
Dr. Long noted that not all of these health centers had Ryan White funding, so it was important to get patients with HIV into regular primary care, but not necessarily linked to an infectious disease specialist—a hand-off which could add time to the process—so that people testing positive could start treatment within a few days. Practices and processes were shared across the 13 centers, he said, so that clinical prompts and clinical decision support were uniform throughout the wider network. Beyond Health Choice Network, the model is scalable and offers a blueprint for all clinics to advance Ending the Epidemic (EHE) goals, he said.
“Now in year six, we’re looking for other ways to expand this work to all of our 90-plus centers across the country [in addition to] Puerto Rico,” Dr. Long concluded.