Expert Analysis: Insights for International Clinicians on New Data From CROI 2020

CoRECT: Relinkage to Care Using Data-to-Care Public Health Strategy

Josep M. Llibre, MD, PhD:
In the United States, only one half of PWH are retained in care.^[33] The issue of retention in HIV care is a challenge in many regions of the world, including in Europe. A relatively new public health strategy to improve retention in care in the United States is the “data-to-care” model, in which local health departments identify PWH who are no longer in care (eg, through HIV surveillance programs or identification by individual healthcare providers) and attempt to locate and re-engage them in care.^[34] To assess the efficacy of the data-to-care model, the US CDC has funded the randomized, controlled, blinded CoRECT trial at 3 trial sites in Philadelphia, Connecticut, and Massachusetts.^[35,36]

Shamasunder and colleagues^[35] presented their analysis of study participants in Philadelphia, Pennsylvania, from August 2016 to January 2018. Across Philadelphia, 8 medical facilities recruited 898 adult PWH who had been in care during the first 12 months of the study period (defined as a medical visit and assessment of CD4+ cell count and/or HIV-1 RNA) and who were out of care from the facility in the 6 months prior to randomization (defined as missing a medical visit and/or assessment of CD4+ cell count and HIV-1 RNA). This study population comprises individuals who are very challenging and very important to treat; because they are not engaged with the health system, they often stop taking their ART and have detectable viremia, as well as opportunistic infections such as TB. Because their HIV infection is uncontrolled, it can be spread in the community.

Participants were randomized 1:1 to the standard of care—which consisted of re-engagement attempts by the medical facility alone (appointment reminder calls, letters, phone calls, text messages, patient portal messages)—vs standard of care plus the intervention. Although the CROI 2020 report did not include an explanation of the specific intervention, according to details provided by the US National Library of Medicine Web site (clinicaltrials.gov), the active health department field services intervention activities vary among different jurisdictions but include field services to locate, contact, and provide assistance to access HIV medical care, including same-day appointments.^[36] The Web site further notes that the intervention may include the involvement of a disease intervention specialist to locate and recruit patients back to HIV care or may use the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention model.^[37] ARTAS is an individual-level, multisession, time-limited intervention for linkage to HIV medical care that is based on the Strengths-based Case Management model rooted in Social Cognitive Theory (particularly self-efficacy) and Humanistic Psychology. This model encourages clients to identify and use personal strengths, create goals, and establish an effective, working relationship with the linkage coordinator.

The investigators analyzed 3 primary outcomes:

1. Linkage to care, defined as having a CD4+ cell count and/or HIV-1 RNA assessment within 90 days of randomization;
2. Retention, defined as ≥ 2 assessments of CD4+ cell count and/or HIV-1 RNA ≥ 3 months apart within 12 months of randomization; and
3. Virologic suppression, defined as 1 measurement of HIV-1 RNA < 200 copies/mL within 12 months of randomization.

That may seem like a high HIV-1 RNA threshold but bear in mind that multiple analyses of U=U suggested that HIV is untransmissible at < 200 copies/mL.^[38,39]

CoRECT: Patient Characteristics

Josep M. Llibre, MD, PhD:
Overall, the study population comprising 898 individuals was predominantly cisgender men (73.05%) and black (65.48%). The most common transmission category was men who have sex with men (44.21%) followed by injection drug use (20.16%). Most (69.5%) were virologically suppressed at their last assessment, but a notable minority (20.71%) had a concurrent diagnosis of AIDS.

CoRECT: Re-Engagement, Retention in Care, and Virologic Suppression

Josep M. Llibre, MD, PhD:
The investigators reported significantly increased rates of re-engagement (43.2% with standard of care vs 61.9% with the intervention; P < .001), retention in care (44.1% vs 59.0%; P < .001), and virologic suppression (55.9% vs 64.1%; P = .012).^[35]

CoRECT: Clinical Implications

Josep M. Llibre, MD, PhD:
Consistent with these higher rates, the intervention significantly improved the odds of being re-engaged in care (OR: 2.22; 95% CI: 1.69-2.92), retained in care (OR: 1.82; 95% CI: 1.39-2.39), and achieving virologic suppression (OR: 1.42; 95% CI: 1.07-1.89; P for all ORs ≤ .02).

To my knowledge, this is the first study demonstrating that additional intervention in this challenging population of PWH lost to care significantly improves re-engagement, retention in care, and virologic suppression compared to standard approaches.^[35] I anticipate that this intervention would have similar success in European populations.

Laura Waters, MD:
The results are impressive for all 3 of those analyzed endpoints. But like Dr. Llibre, I am curious to know exactly what is involved in the intervention because I consider the standard of care to already be good. It would be important to know how much time it took to achieve those results and whether the intensity of effort required for the intervention would really be feasible for routine clinical practice. Did the investigators note how much time it took to re-engage participants in the intervention arm?

Josep M. Llibre, MD, PhD:
No, that was not addressed. The presenters were constrained by the virtual format of CROI 2020, which did not allow the audience to ask questions in real time.