From October 2018 to September 2021, 75 individuals presented to Trillium with a new or preliminary HIV diagnosis and 60 individuals consented to be in the study. All 60 participants agreed to RSA with B/F/TAF during their first HIV appointment with a provider. Fifteen participants were excluded due to false reactive point-of-care tests (14) or transfer of care immediately after diagnosis (1), resulting in study size of 45 participants (Fig. 1).

Screening, enrollment, and retention flowchart

Twenty-six participants received their diagnosis at Trillium, either during routine screening through primary care (10), STI testing or treatment (8), screening for PrEP (7), or an at-home HIV test provided through Trillium’s remote testing service (1). Nineteen participants were diagnosed offsite through STI screening at an independent clinic or primary care office (7), an emergency department visit or hospital admission (5), the local Department of Health STI Clinic (4), a local university’s health center (2), or an over the counter at-home HIV test (1).

There were no statistically significant differences in baseline characteristics between the study RSA and historical control groups (Table 1).

Fourteen of the 60 (23.3%) consented participants who had reactive point-of-care tests were determined to be HIV-negative upon confirmatory testing. All fourteen participants discontinued B/F/TAF, and three (21.4%) patients initiated oral PrEP within seven days of receiving their confirmatory negative HIV-1 RNA test results. No adverse events were reported while these patients were on B/F/TAF in absence of an HIV infection.

The median number of days between HIV diagnosis and clinic presentation in the RSA group was significantly lower than that of the historical control group (Table 2). This same truncation was seen in time from clinic presentation to ART initiation. Commensurate with the preceding, time from diagnosis to ART initiations was significantly shorter in the study RSA group than in the non-RSA control group. In the study RSA group, 33 (76%) participants initiated ART within 3 days of their diagnosis.

All study RSA participants were on B/F/TAF for the entirety of their time on study. The non-RSA historical control patients were on a variety of regimens, with the largest proportion (45.2%) being on a single tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir (TDF or TAF; Appendix B).

There were no virologic failures noted through 48 weeks for those on B/F/TAF. Genotype testing was successfully completed for 39 (86.6%) participants during their time on study. The median time from diagnosis to receiving genotype laboratory results was 23 days (IQR 20–31 days). Among the 39 patients, transmitted drug resistance mutations were present in 10 (25.6%), 8 (20.5%) of which included a major NNRTI mutation. No participants had transmitted INSTI resistance. One participant had genotype results showing a resistance mutation (M184V) against emtricitabine after reaching viral suppression on B/F/TAF. No participants switched regimens due to genotype results. Two participants voluntarily changed regimens after reaching viral suppression, one for gastrointestinal side effects and the other because of a preference for a long-acting injectable.

Forty-three (95.6%) study participants had a documented viral load of < 200 copies/mL by week 48. The remaining 2 participants had an unknown viral load because of patient refusal of laboratory tests. Forty-one (91.1%) reached < 50 copies/mL while on study; the additional 2 participants who did not reach < 50 copies/mL ended study participation less than 3 months after diagnosis.

We compared the viral suppression outcomes of a historical non-RSA population (n = 42) to those of our study population. We found the durations from HIV diagnosis to viral suppression < 200 copies/mL and < 50 copies/mL were shorter in RSA patients than in non-RSA patients (p < 0.001; Table 3).

Furthermore, the times from ART initiation to viral suppression to < 200 copies/mL and to < 50 copies/mL were shorter in RSA patients than in non-RSA patients (p < 0.001). In the study group, 36 (80.0%) participants achieved virologic suppression in 30 days or less from ART initiation. All participants who achieved virologic suppression while on study did so in less than 6 months (maximum 163 days) from ART initiation.

Twenty-nine (64.4%) participants were still engaged in study at 48 weeks. Nine participants left the study before 48 weeks because they transferred care (7) or changed regimens (2). Seven (15.5%) participants were considered lost to care at 48 weeks because they did not present for the final study visit. The median treatment adherence was 93.4% (interquartile range 76.5 − 99.4%), based on pharmacy dispense data.

All enrolled participants started ART the same day as their first appointment. Twenty-seven participants completed the end of study questionnaire. Participant responses regarding how they felt starting ART immediately after their diagnosis were reviewed and several common themes were identified. The first and most common theme was general positivity, defined by feeling happy, good, supported, or relieved at starting ART. The second theme was an expressed readiness to start or not wanting to “waste time” before starting medication. The third theme was a sense of responsibility, which was often defined by the participant feeling ART initiation was the right thing to do for their health. Lastly, some participants expressed being overwhelmed by the diagnosis, but trusted the provider’s advice to start medication.

When asked how we could improve the rapid start process, the majority (21) of participants had no suggestions. Three participants suggested we have fewer team members at the first appointment.

Of the 27 participants who completed the end of study questionnaire, 17 (62.9%) identified at least one barrier to care they experienced over the course of the study. The median number of barriers identified was 2 per participant. The most common barrier to care was lack of stable transportation (Table 4).

In March 2020, the COVID-19 pandemic significantly changed operations at the clinical site. The study protocol was amended to allow for virtual visits and delayed laboratory results. Study appointments transitioned from clinic visits to a majority telemedicine appointments, and participants without phones were given a phone through our Care Management program to complete their appointments. Participants were initially encouraged to delay completing bloodwork due to risk of exposure to COVID-19, but were able to complete STI testing via at home test kits that included self-swabs and a prepaid return envelope. Trillium provided free pharmacy delivery to the patients’ homes or location of their choosing. Patients who were homeless or unstably housed could pick up their medication “curbside,” with no direct contact.