Accelerated initiation of antiretroviral therapy by virtual health in service members newly diagnosed with HIV infection

Abstract

Objectives

Delays in HIV antiretroviral therapy (ART) have been associated with HIV disease progression and forward transmission. We evaluated the effectiveness of an accelerated ART virtual protocol (VP) for active duty (AD) members with incident HIV diagnosis.

Methods

Under the traditional protocol (TP), service members stationed worldwide were evaluated in-person at Brooke Army Medical Center (BAMC) and received comprehensive HIV care. In February 2020, a VP was adopted to initiate HIV care at the local base. Chart reviews were conducted to obtain patient demographics and clinical data. Continuous variables were compared using 2-tailed t tests, categorical variables were evaluated with Fisher’s exact or Chi squared tests.

Results

Time from HIV notification to ART initiation was significantly shorter with the VP compared to the TP (15 days vs 25 days; p = <0.05). The VP had a shorter time to viral suppression compared to the TP (96 days [SD ± 86] compared to 269 days [SD ± 300], p = <0.05).

Conclusions

The VP was associated with a shorter time to HIV specialty evaluation, ART initiation, and viral suppression. The use of virtual health protocols for other time sensitive medical interventions and/or for access to limited specialties should be considered as these may improve quality of care.

Keywords

Antiretroviral therapy < other human immunodeficiency virus < viral disease treatment < other

Introduction

Contemporary combination antiretroviral therapy (ART) with once daily oral administration has proven highly effective with as many as 97% of subjects achieving viral suppression within 3 months.¹ Army and Air Force regulations require all active duty service members undergo HIV screening at least once every 2 years. Delays in therapy initiation are associated with increased morbidity, mortality, and forward transmission of infection.^2–4 This current understanding underlies the notion that an accelerated delivery of ART to those with incident HIV diagnosis would result in improved outcomes and spawned shifts in treatment paradigms.⁵

Following HIV diagnosis both United States Army (USA) and United States Air Force (USAF) regulations require all patients undergo evaluation by an active duty (AD) Infectious Disease (ID) physician.^6,7 These specialists are not available locally among many military facilities. To adhere to regulations, all AD USAF members worldwide and AD USA members stationed within the Central Regional Health Command (encompassing 8 unique bases across 6 states) were evaluated in person at the Brooke Army Medical Center (BAMC) ID clinic. Under this process the time from HIV diagnosis to ID evaluation was approximately 30 days but may have been longer depending on individual patient circumstances leading to treatment delays.

Limits to HIV care access have many facets, including transport constraints, travel times, and the cost of care. The military has the added challenge of a wider geographic distribution of personnel. With the adoption of telemedicine, an opportunity to decrease the time from HIV diagnosis to specialty consultation and therapy initiation presented itself. The objective of this endeavor was to assess whether the application of a telemedicine, hereinafter referred to as the virtual protocol (VP), resulted in faster ART initiation.

Design

Under the traditional protocol (TP), regional USA and all USAF members received in-person, comprehensive HIV care. In February 2020, a VP (Figure 1) was adopted. In the VP, following initial HIV notification, primary care providers were instructed to obtain baseline laboratory studies required for ART initiation. A collaborative approach was pursued due to limitations of the electronic medical record (EMR). Suitable labs included all of the following: Laboratory tests included quantitative HIV RNA level, CD4 count, HIV genotype, viral hepatitis serologies, sexually transmitted infection testing, chemistry panels, complete blood count with differential, urinalysis, pregnancy test (if applicable) and a lipid profile. Genotype testing was required prior to ART initiation. Once collected, ID physicians conducted ad hoc telephonic counseling regarding ART regimens, initiated ART, and arranged a virtual comprehensive appointment during normal clinic hours. To ascertain the effectiveness of the VP, all AD members with incident HIV diagnosis between February 2018 and February 2022 with documented HIV notification were reviewed. AD members who did not undergo evaluation at the clinic (evidenced by incomplete EMR documentation) were excluded. The primary outcome of interest was the interval of time between HIV notification and first ART prescription. EMR reviews collected patient demographics and clinical data (initial CD4 counts, viral loads, and HIV genotyping (yes/no)). Dates of interest included the date of: first positive HIV test (reflecting the time the HIV sample was collected), HIV diagnosis notification, ID consultation, first suppressed viral load (<200 copies/mL), and ART prescription. Cost savings from the VP were estimated based on a 5-day temporary duty trip, per diem rates for Bexar County, a flight length of 170 miles (340 miles round trip), and a mileage cost of $1.27/mi.⁸ Continuous variables were compared using 2-tailed t tests, categorical variables were evaluated with Fisher’s exact, or Chi squared tests. On review of this project, The Human Research Protections Office found the activity does not meet the definition of research as defined in 32 CFR 219.102(l) as it is not a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.

Figure 1.

Flow diagram of the virtual protocol. Outlined steps were only employed during 2020–2022.

Information

A total of 191 USAF and USA members were diagnosed with HIV during the period of interest, with 154 AD members included in the final analysis. Eighteen were excluded due to non-AD status, and 19 had incomplete EMR documentation. Patients were predominantly male (97%), young (mean age 27 years old), enlisted (90%), and African American (40%). Eighty-two patients were diagnosed during the TP, 72 during the VP (Table 1). Clinical and demographic data were similar between groups, though the VP had a lower median CD4 count at diagnosis (478 cells/µL [IQR 332-588] vs 542 cells/µL [IQR 430-709] p = 0.02). The average time from positive HIV test collection and patient notification was the same between groups (14 days; p = 0.96). However, time from HIV notification to ART initiation was significantly shorter during the VP compared to the TP (15 days vs 25 days; p = <0.05). Similarly, time from diagnosis notification to ID evaluation was shortened (19 days vs 25 days; p = <0.05). Seventeen VP patients had not yet achieved documented viral suppression at time of data collection, and 4 in the TP. The VP had a shorter time to viral suppression compared to the TP (96 days [SD ± 86] compared to 269 days [SD ± 300], p = <0.05). Finally, HIV genotype results were less likely to be documented in the EMR using the VP (76% vs 98%; p = <0.05).

Table 1.

Characteristics of active duty members with newly diagnosed HIV infection.

Characteristics	Traditional protocol	Virtual protocol	p value
Number, N (%)	82 (53)	72 (47)
Gender, male	79 (96)	71 (99)	0.62
Mean age, years, ± SD	27 ± 6	27 ± 6	0.40
Branch of service			0.26
Air force	48 (59)	35 (49)
Army	34 (41)	37 (51)
Rank			0.60
Enlisted	75 (91)	64 (89)
Officer	7 (9)	8 (11)
Race			0.55
Caucasian	27 (33)	27 (37)
Black	37 (45)	25 (35)
Asian	4 (5)	3 (4)
Other^a	14 (17)	17 (24)
Median viral load, log₁₀ copies/mL (IQR)	4.44 (3.6–4.8)	4.43 (3.99–5.15)	0.31
Median CD4 count, cells/µL (IQR)	542 (430–709)	478 (332–588)	0.02
HIV genotype documented	80 (98)	55 (76)	<0.005
Mean time from last negative to first positive HIV test, months, ± SD	13 ± 8	17 ± 13	0.01
Mean time from positive HIV test to result notification, days, ± SD	14 ± 9	14 ± 9	0.96
Mean time from HIV notification to ART initiation, days, ± SD	25 ± 18	15 ± 10	<0.05
Mean time from HIV notification to infectious disease evaluation, days, ± SD	25 ± 18	19 ± 16	0.03
Mean time from HIV notification to viral suppression, days, ± SD^b	269 ± 300	96 ± 86	<0.05

^aElectronic medical record listed race as other/unknown.

^bViral suppression <200 copies/mL, 25 patients in the virtual period had not yet achieved viral suppression, and 4 in the traditional period did not have follow-up data showing suppression.

Lessons learned

ART mediates its effects on morbidity, mortality, and transmission by its ability to suppress HIV viremia. Among the many obstacles in delivering care to individuals living with HIV, the accelerated initiation of ART was a unique challenge under the conditions of military service. The VP developed was associated with a shorter time to ART initiation and specialty evaluation, notably without additional staffing, equipment, or funding required.

To our knowledge, this is the first analysis of novel telemedicine protocols on HIV care in the US military. The use of telemedicine for HIV care delivery increased from 22% to 99% by one report, driven largely in part by the COVID-19 pandemic.^9,10 Studies examining the applications of telemedicine on HIV care in the civilian sector have evaluated differing, albeit equally important, clinical endpoints.^11–15 Amatavete and colleagues evaluated telemedicine retention in care with their Thai, same day ART initiation clinic and found no differences for patients who engaged in telemedicine versus in person care at 6 months, 94.1% versus 98.4%, p = 0.148.¹⁶ Similar comparisons are not directly applicable to our population since military regulations mandate routine clinical visits. The time from HIV diagnosis to initial ID evaluation, however, was shortened to 19 days through VP utilization. In contrast, an HIV clinic in Boston found the majority of patients delayed clinical presentation for up to 3 months following initial diagnosis.¹⁷ The use of telemedicine may serve as a flexible and convenient tool to reach patients.

The issue of virologic suppression, a key clinical goal in HIV care, with the use of care delivered through telemedicine had been previously evaluated. However, these studies included populations where the majority of patients were without incident HIV diagnoses and often found similar rates of overall viral suppression with interventions incorporating telemedicine.^11–15 Evaluating the time from diagnosis to viral suppression, one study found a greater proportion of subjects achieved viral suppression during the first 6 visits in the telemedicine group compared to an in-person control, 91.1% versus 59.3%; OR, 7.0 (95% CI, 5.1–9.8); p < 0.001.¹² Our patient population almost uniformly achieves viral suppression, and the VP builds upon this by displaying a shorter time to virologic suppression than conventional methods. This finding may be partially explained by the more consistent clinical follow up with routine labs compared to the TP, and further evaluations could confirm the reliability of telemedicine amidst different environments, infrastructures, and populations.

Other studies have reported higher initial CD4 counts compared to ours, but some of these included patients without incident diagnoses making direct comparisons difficult.^11–15 The exact reasons for the former are unclear and warrant further evaluation in the future. Regarding the transition from the TP to the VP, no financial costs were required; rather, $97,575 were saved in travel costs alone, and 360 days of duty time were recovered. This was a conservative estimate, as flight costs were estimated at the lower range of potential costs during the VP (departures and arrivals were not known with any fidelity for each of the service members).

Limitations of this intervention include the unblinded, observational design of the review. Similarly, findings completed within the military, a population being medically screened prior to service, limits the generalizability of the results to the civilian population. Given the 2-year difference between the compared groups, uncensored viral suppression times will be skewed to shorter times under the virtual period since a longer follow up period is captured under the traditional period, which may have a greater effect than that observed from shorter times to ART initiation. The shorter captured follow up period in the VP may also underlie the observation that HIV genotype results were less likely to be documented in the EMR using the VP, as it provides more time for the results to be organized. An interval analysis would clarify if an aspect of the VP could be responsible for this observed difference. The consistent period between the positive HIV test and notification is a strength of our results and supports the thought that this aspect of the workflow was well controlled and that the receipt of collection results was reliable. This evaluation also benefits from consistent first line recommended HIV treatment regimens during the reviewed period.

In the pursuit of HIV eradication and control worldwide, the current report supports the use of virtual protocols in locations where specialty care is scarce or absent. Similar programs to ours can help improve HIV clinical outcomes, including mortality, morbidity, and transmission. Further studies should explore the potential effect of telemedicine on patient education, satisfaction, and clinical support requirements.

Data Availability Statement: For ethical reasons which include adverse impact to HIV-infected United States Air Force personnel still in service, data will not be made publicly available. Data is available only upon individual request. The requests may be sent to anatole.t.openshaw.mil@health.mil.

The views expressed herein are those of the authors and do not reflect the official policy or position of Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force, the Department of Defense or the U.S. Government.

Supplemental Material

Supplemental Material - Accelerated initiation of antiretroviral therapy by virtual health in service members newly diagnosed with HIV infection

Supplemental Material for Accelerated initiation of antiretroviral therapy by virtual health in service members newly diagnosed with HIV infection by Anatole Openshaw, Jason Okulicz and Joseph Yabes in International Journal of STD & AIDS.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Anatole Openshaw

Supplemental Material

Supplemental material for this article is available online.

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