Guidance: Rapid Antiretroviral Therapy (ART) Initiation During COVID-19

Guidance: Rapid Antiretroviral Therapy (ART) Initiation During COVID-19

Rapid ART Remains a Priority

Lead author: Asa Radix, MD, MPH, PhD, with the Medical Care Criteria Committee, August 2020

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The COVID-19 pandemic and ongoing social distancing measures have limited access to routine and urgent medical care significantly. There are few data on how COVID-19 affects HIV risk, although sexual activity among men who have sex with men has declined during the pandemic [Hammoud, et al. 2020; Sanchez, et al. 2020; Santos, et al. 2020]. Effects of COVID-19 that may enhance HIV risk include reduced access to condoms and HIV testing [Sanchez, et al. 2020; Santos, et al. 2020], increased use of dating apps among youth [Sanchez, et al. 2020], reduced access to pre-exposure prophylaxis (PrEP) [Santos, et al. 2020], and increased use of alcohol and recreational drugs [Sanchez, et al. 2020]. During the pandemic, sex workers have had fewer transactions as a result of social distancing, curfews, and fear of acquiring COVID-19, and consequently have experienced considerable economic vulnerability, which may influence decisions about condom use [Callander, et al. 2020; Kimani, et al. 2020]. Sex workers may also face limited access to condoms, PrEP, and HIV testing.

Despite the challenges posed by the COVID-19 pandemic, expeditious initiation of antiretroviral therapy (ART) in people newly diagnosed with HIV remains a high priority and can be accomplished with modest adjustments to the established protocol. This guidance aims to assist primary care providers and other clinicians in adjusting the protocol for implementing rapid ART initiation during the COVID-19 pandemic.

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Remember to Test for HIV

Clinicians are urged to remember to test for HIV, especially among individuals at risk. Primary care and urgent care providers should continue to offer options for HIV testing, even when seeing patients via telemedicine. Symptoms of acute HIV infection may be difficult to distinguish from those of COVID-19; therefore, testing for acute HIV should be considered in addition to testing for COVID-19 when patients present with signs or symptoms of acute retroviral syndrome. When a patient’s HIV test result is reactive, from either an on-site or home-based HIV test, medical care providers should still provide all necessary counseling and patient education, following the guidance in the current protocol for rapid ART initiation. 

Recognize the Need for Additional Assistance

Many people have experienced COVID-19–related disruptions in their lives, including loss of employment, medical insurance, and housing, and disconnection from social supports. Many people may be experiencing new or exacerbated symptoms of depression, anxiety, other mental health problems, or substance use [Hochstatter, et al. 2020; Holingue, et al. 2020]. Clinicians should be aware of these issues and recognize any increased need for behavioral health services, housing assistance, resources for people experiencing intimate partner violence, and access to payment assistance for ART.

Baseline Laboratory Testing

Baseline laboratory testing should be performed before ART is initiated; however, it is not necessary to obtain results before initiating ART. Whenever possible, an individual who has a reactive home-based test result should be linked to on-site care and laboratory testing, including confirmatory HIV testing.

Baseline Laboratory Testing Checklist 
  • HIV-1/2 antigen/antibody assay
  • HIV quantitative viral load
  • Baseline HIV genotypic resistance profile
  • Baseline CD4 cell count
  • Testing for hepatitis A, B, and C viruses
  • Comprehensive metabolic panel (creatinine clearance, hepatic profile)
  • Urinalysis
  • Sexually transmitted infection screening
  • Pregnancy test (individuals of childbearing potential)

Follow-Up

If a baseline HIV test result is positive and ART is initiated, the recommended protocol (see figure, above) for follow-up includes a telephone call within 24 to 48 hours to assess ART medication tolerance and adherence, and a medical visit within 7 days. This visit may be conducted via telehealth instead of the suggested in-person visit to reduce a patient’s need to travel and risk of exposure to COVID-19. Case management, health education, and peer and other support services can also be coordinated virtually. Adjustments to ART regimens to improve tolerability or in response to results from resistance testing can be made during telehealth visits as well.

If a sexually transmitted infection other than HIV is diagnosed during baseline testing, it can be treated, if clinically appropriate, using alternative oral regimens for gonorrhea and syphilis [Workowski, et al. 2015]. See NYC Health > Presumptive oral treatment of uncomplicated anogenital gonorrhea infection in the absence of ready access to injectable treatment during the COVID-19 crisis, New York City, 2020.

Prescriptions

Many pharmacies provide home delivery of medications, which can reduce the risk of travel outside the home. Many insurance companies are now allowing 90-day prescriptions, which are appropriate after a patient has completed the first 30 days of ART. Before prescribing 90 days of medication, a clinician should evaluate a patient’s early viral response and resistance testing results and ensure that the regimen is well tolerated.

Telemedicine vs. In-Person Medical Care

When planning for medical visits, care providers and their patients should weigh the potential risk of exposure to COVID-19 against the potential benefits of in-person visits, which may include the risk of exposure to COVID-19 based on rates of community transmission, concurrent medical conditions and degree of immunosuppression, all of which should be considered. Telehealth-only visits delay provision of necessary vaccinations, examinations, and procedures, including anal and cervical cytology, so care providers should encourage patients to have an in-person visit within 6 months of starting ART to ensure that such care can be delivered.

Although high acceptability of telehealth services for HIV care has been reported [Dandachi, et al. 2020], some patients will not have access to telehealth services because they do not have a smartphone, computer, or internet access. Difficulty using telehealth options has been reported to be more prevalent among the elderly, those in poorer health, and Black and Hispanic individuals [Lam, et al. 2020]. The plan to offer online telehealth, on-site visits, or some combination of these should take into account the feasibility and acceptability of each option and an individual patient’s medical needs. Some patients may prefer or have access to telephone visits only.

When counseling patients and preparing for an in-person visit, it is important to address how to reduce exposure to COVID-19 through social distancing, wearing a face covering or mask, frequent hand washing, and limiting the time spent in areas of high community transmission.

Medical care providers may have concerns about delivery of telehealth services, especially related to issues of patient confidentiality, insurance reimbursement, and access to telehealth technology. Important regulatory changes have been made to allow Health Insurance Portability and Accountability Act (HIPAA)-covered clinicians to use remote and easily accessible communication technologies, such as FaceTime, Zoom, and Skype, to provide telehealth services, even if the technologies themselves are not fully HIPAA-compliant (see HHS.gov > Telehealth: Delivering Care Safely During COVID-19). In addition, the Centers for Medicare and Medicaid Services (CMS) now allow people who are enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) to receive medical care through telehealth services and allow clinicians to bill for services as if they were provided in person. Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) can also now provide telehealth services to patients in their homes and qualify for reimbursement.

Follow-Up Laboratory Testing

If a patient’s follow-up laboratory testing cannot be performed at the clinician’s office, testing can be ordered at a commercial laboratory that is convenient for the patient. There are services available to acquire samples for laboratory testing in a patient’s home, although most charge a convenience fee that may not be covered by insurance plans.

Resources for Laboratory Testing

For recommendations and discussion, please see these sections of the NYSDOH AI guideline When to Initiate ART, With Protocol for Rapid Initiation:

References

Callander D, Meunier E, DeVeau R, et al. Investigating the effects of COVID-19 on global male sex work populations: a longitudinal study of digital data. Sex Transm Infect 2020:[Epub ahead of print]. [PMID: 32591488]

Dandachi D, Dang BN, Lucari B, et al. Exploring the attitude of patients with HIV about using telehealth for HIV care. AIDS Patient Care STDS 2020;34(4):166-172. [PMID: 32324481]

Hammoud MA, Maher L, Holt M, et al. Physical distancing due to COVID-19 disrupts sexual behaviours among gay and bisexual men in Australia: Implications for trends in HIV and other sexually transmissible infections. J Acquir Immune Defic Syndr 2020:[Epub ahead of print]. [PMID: 32740374]

Hochstatter KR, Akhtar WZ, Dietz S, et al. Potential influences of the COVID-19 pandemic on drug use and HIV care among people living with HIV and substance use disorders: Experience from a pilot mHealth intervention. AIDS Behav 2020. [PMID: 32705370]

Holingue C, Badillo-Goicoechea E, Riehm KE, et al. Mental distress during the COVID-19 pandemic among US adults without a pre-existing mental health condition: Findings from American Trend Panel Survey. Prev Med 2020:106231. [PMID: 32758507]

Kimani J, Adhiambo J, Kasiba R, et al. The effects of COVID-19 on the health and socio-economic security of sex workers in Nairobi, Kenya: Emerging intersections with HIV. Glob Public Health 2020;15(7):1073-1082. [PMID: 32459578]

Lam K, Lu AD, Shi Y, et al. Assessing telemedicine unreadiness among older adults in the United States during the COVID-19 pandemic. JAMA Intern Med 2020. [PMID: 32744593]

Sanchez TH, Zlotorzynska M, Rai M, et al. Characterizing the impact of COVID-19 on men who have sex with men across the United States in April, 2020. AIDS Behav 2020;24(7):2024-2032. [PMID: 32350773]

Santos GM, Ackerman B, Rao A, et al. Economic, mental health, HIV prevention and HIV treatment impacts of COVID-19 and the COVID-19 response on a global sample of cisgender gay men and other men who have sex with men. AIDS Behav 2020:[Epub ahead of print]. [PMID: 32654021]

Workowski KA, Bolan GA, Centers for Disease C, et al. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015;64(RR-03):1-137. [PMID: 26042815]