Impact of Telehealth in HIV Ambulatory Clinic during COVID-19 Pandemic

doi:10.21203/rs.3.rs-1746554/v1

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Impact of Telehealth in HIV Ambulatory Clinic during COVID-19 Pandemic

https://doi.org/10.21203/rs.3.rs-1746554/v1

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Background

The COVID-19 pandemic has changed HIV outpatient care. Patients (pts) were transitioned from in-person (IN-P) visits to telehealth (TELE) encounters. We sought to evaluate the impact of TELE on HIV infected pts during the pandemic period (COV) and compare it to the pre-pandemic (pre-COV) care.

Methods

A retrospective study in an outpatient HIV clinic. Two periods were defined: Pre-COV 3/16/2019 - 3/15/2020 and COV 3/16/2020- 3/15/2021. Data was collected on demographics, lab values and physician encounters.

Results

A total of 1136 pts were seen over 2 years, mean age 51.6 years. During pre-COV, 530 pts were seen IN-P and 606 pts had encounters during COV, of them 50.2% had exclusive TELE visits. The percentage of pts with CD4 > 200/µL and those with undetectable HIV VL at first and last encounter were compared between the two study periods. During pre-COV, there was no difference in the percent pts with CD4 > 200/µL (B90.5% vs. 94.3%, p=.87) or HIV VL (88.5% vs. 90.3%, p=0.41) but during COV there was significant difference in CD4 (90.3% vs. 94.2%, p=0.03) and HIV VL (87% vs. 93%, p=0.002). More new pts were seen and less changes to ART regimens were done during COV (8.6%vs 7 p=0.26) and (19% to 29%, p=0 .32) respectively.

Conclusions

In our clinic, transitioning to TELE resulted in larger number of encounters and more new pts entered care; CD4 and HIV viral load improvements were seen. TELE is an effective platform for HIV out patient care.

The COVID-19 pandemic has changed the practice of medicine and disrupted normal healthcare practices especially in the outpatient setting. In the past, patients(pts) living with HIV (PLWH) received their care by mostly IN-P, as the COVID–19 pandemic unfolded, outpatient management of PLWH needed to adapt to the new reality of stay at home mandates and the fear of contagion. A transition to alternative modes of care such as telemedicine (TELE), defined as remote electronic health care services including video interactions, telephone communication and asynchronous messaging, were implemented in many clinics. Congressional House Bill 6074, allowed the department of Health and Human Services to waive certain TELE restrictions, facilitated transition to TELE and this was coupled with emergency declaration waivers from the Centers for Medicare and Medicaid Services. (1, 2)

Our HIV outpatient clinic is located at Beth Israel Medical Center in Newark NJ, a tertiary care teaching hospital. Prior to the COVID-19 pandemic, all our patients were seen as IN-P every 3 to 4 months, every patient was seen by an infectious diseases physician, and by multidisciplinary care team that included a social worker, drug counselor, nutritionist and a psychologist as necessary.

When the COVID-19 pandemic started, care in our clinic was transitioned to TELE and as the time went on some in person (IN-P) visits were resumed.

The goal of this study was to review our experience with TELE.

The study was conducted in a 680-bed tertiary care teaching hospital. This was a retrospective review. IRB approval with exemption of informed consent was obtained. The study period was from 3/16/2019 to 3/15/2021. Two study periods were defined based on time periods: pre-COVID (pre-COV) 3/16/2019 -3/15/2020; COVID (COV) 3/16/2020 -3/15/2021. Data was collected for demographics, HIV infection risk, number of new pts enrolled in the clinic during each study period, number and type of encounters (either IN-P or TELE). Unduplicated pts with \(\ge\) 1 visit were included independent of the number of times the pt was seen during that period. An Infectious Diseases physician conducted all TELE encounters via telephone communication. Pts’ lab work was reviewed on a computer screen in real time during the TELE encounter. Prior to the encounter, pts received an automatic computer generated phone reminders about their upcoming appointment. Pts were instructed to do their blood work a few weeks before a scheduled appointment, lab work and included a complete blood count, complete metabolic panel, CD4, HIV Viral load during every visit. A yearly hepatitis panel, serum Quantiferon, RPR and chlamydia and gonorrhea urine PCR were obtained. CD4 counts and HIV viral loads at each visit were recorded. We compared percent of pts with undetectable HIV VL and CD4 above 200cells µL between first and last visits in each period. HIV viral load of < 200 copies/mL was considered undetectable.

Data was collected on antiretroviral (ART) regimen and on any changes to medications during each study period.

Demographics were summarized by mean values. Student’s t- test was used for comparisons between groups. P value of ≤ 0.05 was set as significant.

Overall, 1136 pts had at least one physician encounter in the 2 years study period. Median age 54 years. (IQ Range-42-62). Overall, there were 571 (50.3%) cis-gender males, and 4 (0.35%) transgender patients; Blacks 1017(89.5%), Hispanics 94 (8.3%) Caucasians 15(1.3%) and Asians 6 (.5%). Risk factors for HIV acquisition: Heterosexual transmission in 827 (73%), male having sex with male (MSM) in 217 (19.1%), combination of MSM and intravenous drug use (IDU) 15 (1.3%), IDU 16 (1.4%), perinatal transmission in 33(3%), Transfusion of products 14(1.23%), hemophilia 4 (.4%) and unspecified risk in 10 pts (0.9%). Co-morbid conditions were hypertension in 380(33.5%), obesity 324 (28.5%), dyslipidemia 277(24.4%), DM in 75(6.6%), Hepatitis C 79 (7%), Chronic kidney disease 102 (9%) and Hepatitis B 55 (5%) pts. Most patients were on integrase inhibitor based regimens.

PRE- COV Visits

During pre-COV period, 530 unduplicated patients had IN –P visits. A single visit occurred in 71 (13.4%), 179 (34%) had 2 visits, 183 (35%) had 3 visits, 91(17%) had 4 visits, 5 (0.9%) had 5 visits and one patient (0.2%) had 6 visits. Median number of patient encounters was 3. The clinic accepted 36(7%) new patients. (Table 2)

COV Period Encounters

During the COV period, 606 unduplicated pts had at least one physician encounters, of these 304 (50.2%) were TELE encounters, 89(14.7%) IN-P, and 213(35%) had a combination of both TELE and IN-P (Figure 1); 127 (21%) pts had a single encounter, 178 (29%) had 2 encounters, 200 (33%) had 3 encounters, 95(16%) had 4 encounters and 6 (1%) had 5 encounters. Median number of encounters was 2. Twenty-five clinic pts who missed appointments and were not seen during the pre-COV period had an encounter during the COV period. During COV 52(8.6%) new patients entered care compared to 36(7%) in the pre-COV (p=0.26). (Table 2)

Pre- COV period: CD4 and HIV Viral Loads

During the pre-COV period, 373/ 530 (70.3%) pts had their CD4 count and HIV VL measured at first and last encounter; median CD4 value at the first visit was 623µL (Range 5-2105) and 662µL (Range 8-2438) at the last visit. CD4 >200/µL at first visit was seen in 353/373(95%) and in 352/373 (94.3%) at the last encounter (p=.87).

HIV VL was undetectable in 330/373 (88.5%) at the first encounter and in 337/373(90.3%) at last encounter. (p=0.41). [Table 3a]

COV Period: CD4 and HIV Viral Loads

During COV period, 445/606 (73.4%) pts had CD4 measured at first and last encounters, median CD4 at the first encounter was 617µL (Range 3-2486) and 627µL (Range 412-850) at the last encounter. CD4 count ≥ 200/µL at first encounter was seen in 402 (90.3%) and in 419(94.2%) at the last visit had (p=0.03); HIV Viral load was measured at first and last encounters in 448/606(73.9%) pts. HIV VL was undetectable in 389(87%) at the first visit and in 417(93%) at the last visit (p=0.002) [Table 3b]

During COV there were less changes to ART regimens compared to pre-COV 116 (19%) compared to 153(29%)] (p=0 .32).

Significantly higher percentage of pts had CD4 >200µL during the first visit in pre-COV period compared to COV [353/373 (95%) vs. 402/445 (90.3%), p=0.02]. However, no statistical difference was noted by last visit (352/373 (94.3 %), 419/445 (94.2%), p=0.89). (Table 4) There was no significant difference in percent of patients with undetectable HIV VL in the first visit [330/373 (88. 5%) vs. 389/448(87%), p=0.47] or during the last visit [337/373 (90.3%) vs. 417/448(93%) p=0.15] between Pre-COV and COV. (Table 4)

Despite changes in the delivery of care from exclusively IN-P to mainly TELE, our study found that more pts received care during COV compared to the pre-COV period. More new pts entered care in the COV period compared to the pre-COV; improvement in CD4 counts and VL suppression rates were significantly higher when measured at first and last encounters in the COV period. There were no significant differences in the percent of patients with CD4 counts > 200µl or viral load suppression in first and last encounters during the two study periods. The study found that during COV there were less changes to ART regimens compared to the pre-COV period.

The COVID-19 pandemic has interrupted the delivery of care and forced clinics to shift to TELE in order to continue to provide care, to PLWH.

Experience of HIV care with TELE has been described in a number of studies prior to the COVID-19 pandemic. In a study by OHL et al (3) at the VA system, participants in TELE needed to travel to a clinic in order to connect with their health care provider for a TELE encounter. These pts reported a high rate of satisfaction, a decrease in travel time to care but there was no difference in retention in care or viral suppression compared those who did not participate in TELE. The same investigators reported on a larger study and found that only 120/1670 (13%) elected to participate in TELE; Participants had a higher number of visits and more frequent viral load testing but there was no improvement in HIV suppression when compared to non-participants. (4)

In a study of HIV care in a correctional institution using TELE (5) pts who participated in the TELE group had greater virological suppression and higher CD4 counts.

Experience in transition to TELE during the COVID-19 pandemic is starting to emerge, Fadul (6) reported that adoption of TELE utilizing phone communication in the early months of the pandemic, resulted in a reduction in the number of visits frequency but a maintenance of viral load suppression. Mayer et al. (7) reported that in the first 2 months of the pandemic, visit frequency and viral load suppression were not interrupted after transitioning to either phone or video encounters.

Spinelli et al, (8) evaluated viral suppression after implementing TELE in a clinic in San Francisco, the authors described a significant reduction in viral suppression rates of 31% when compared to the pre COVID- 19 pandemic. The authors stated that despite access to TELE, the patients had reduced access to social support services likely affecting care. Homelessness in this study was 16% and was associated with non-viral suppression. Our study in comparison, has found that more pts were seen during COV compared to pre-COV; HIV viral load suppression rates were higher during the COV period between first and last encounters. When comparing first and last visit measurement between the two periods, there was no statistical difference, a fact that supports the notion that TELE can provide effective way to maintain good clinical outcomes to PLWH.

The study by Spinelli (8) and Mayer (7) had a much shorter follow up periods compared to our study, which had a one year follow up in each period.

Sorbera et al (9) compared HIV pts’ viral load suppression in a clinic transitioning to TELE between two periods, pre-COV and post –COV. They found that in their 211 pts there was no significant difference in viral load suppression rates, but the percent of patients with CD4 cell counts > 200µl were higher in the pre-COV compared to the post COV period. In comparison, our study showed no difference in either the percent of pts with CD4 counts > 200µL or those with viral load suppression between the two periods.

TELE has some limitations; pts may feel uncomfortable talking about their medical conditions / medications over the telephone, pts may have accessibility issues, and there may be language and communication barriers.

Some studies found different uptake rates in different patient populations. Data on TELE uptake using phone from Cardiology and Gastroenterology clinics showed that population similar to ours: minority groups, relatively older and female gender were likely to use TELE via phone as was found in our study. (10, 11)

A cross sectional study in Italy using self-report questionnaire 80 PLWH and 60 doctors noted that 88% of the physicians and 40% of PLWH did not want to substitute IN-P with TELE (12). Another study noted that most patients were satisfied in general with TELE but some pts mostly women had some concerns about lack of physical exam and worried about safety of personal information (13).

Wood et al. (14) found that older age, people of color and patients on Medicaid coverage tended to use less TEE services (14).

Amatavete et al noted retention rates of 98% at 3 months and 98.4% at 6 months with the use of TELE during COVID in PLWH (15). Our study followed pts for a year and noted that after implementation of TELE during COV, more r new pts were accepted to the clinic (8.6% vs. 7%) and more pts had HIV VL suppression at the end of one year supporting the notion that TELE is an effective platform for the delivery of care and can supplement IN-P care.

Our study has a few limitations; it is a single center observational study, the study took place in an inner city hospital and therefore results may not be generalized. The study was retrospective and therefore all limitations of a retrospective analysis apply. The study used only telephone encounters, and therefore we may have missed some pts who did not have means to communicate or that would have preferred to use another communication platform.

Some of the strengths of our study were the relatively long follow up periods of one year in each of study periods. The fact that viral load and CD4 counts were tabulated at first and last encounters allowed a better analysis of patients’ progression and effectiveness of TELE. Our study also recorded the number of new patients enrolled between the two periods a fact that allows a better perspective of TELE as a platform for the delivery of care for PLWH.

In our clinic, TELE was an effective tool to care for PLWH; this was evidenced by maintenance of high CD4 counts and virological suppression. In the face of a changing world of health care TELE seems to be an important tool in the care of PLWH.

Acknowledgement: Donna Georgefor providing the data

Funding: none

Author Contributions: Author 1 (SN) wrote the manuscript, authors 2 (EB) and 3 (KE) edited the manuscript. All authors reviewed the manuscript.

Data availability Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request

Conflict of interest: None to declare

H.R, 6074- Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020:http:// WWW.congress.go/bill/116th-congress/house-bill 6074.
COVID-19 Emergency Declaration Waivers for Health Care Providers: http://WWW.cms.gov/files/document/summary-covid-19 emergency -declaration -waivers.pdf.
Ohl M, Dillon D, Moeckli J, et al. Mixed –methods evaluation of a telehealth collaborative care program for persons with HIV infection in a rural setting. J Gen Intern Med. 2013; 28:1165–73
Ohl ME, Richardson K, Rodriguez –Barrada s MC, et al. Impact of availability of telehealth programs on documented HIV viral suppression: a cluster randomized program evaluation in the Veterans Health Administration. Open Forum Infect. Dis. 2019 ; 6 Ofz206
Young JD, Patel M, Badowski M et al. Improved virologic suppression with HIV subspecialty care in a large prison system using telemedicine: an observational study with historical controls. Clin Infect Dis. 2014;59;123-6.
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Table 1: Demographics of Patients

Pre-COV

COV

Number of patients

530

606

Age ( Median)

Cis-gender Male

Transgender

266

305

Risk Factor

Heterosexual

MSM

MSM+ IDU

IDU

Perinatal transmission

Transfusion related

Hemophilia

Unspecified

391

436 118

Co-Morbid Conditions

HTN

Obesity

Dyslipidemia

Hepatitis C

CKD

Hepatitis B

182

153

133

195

170

144

ARV Regimen

INT inhibitor based

INT+ NNRTI

NNRTI

PI+INT

ELITE CONTROLLER

NO ARV SECONDARY TO OTHER INFECTIONS

317

379

2( 1 SECONDARY TO ACTIVE MAI, 1 SECONDARY TO ACTIVE TB)

Table 2: Physician encounters

Physician encounters	Pre-COV (n=530)	COV (n=606)
Number of physician visits One Two Three Four Five Six	71 (13.4) 179 (34) 183(35) 91(17) 5(0.9) 1(0.2)	127(21) 178(2) 200(3) 95 (16) 6(1) 0
Type of visit TELE IN-P Combination - TELE and IN-P	0 530 0	304(50.2) 89(14.7) 213(35)
Number of New patients	36(7)	52(8.6)
Median number of physician encounters	3	2

Table 3a: CD 4 and HIV VL at first and last visits: Pre-COV period

	First visit	Last visit	P value
Median CD4 µL	570	609
CD4 > 200/ µL	353(95%)	352(94.3%)	0.87
HIV VL <200 copies/mL	330 (88.5)	337(90.3%)	0.41

Table 3 b: CD4 and HIV VL at first and last encounters: COV period

	First visit	Last visit	P value
Mean CD4µL	606	627
Percent of CD4 above 200/ µL (n=445)	402(90.3)	419(94.2)	0.03
HIV VL (n=448)	389(87)	417(93)	0.002

Table 4: Comparing Pre-COV and COV: CD4, HIV VL and ARV regimen changes

	Pre-COV (n=373)	COV (n=445 for CD4 and 448 for HIV VL)	P value
CD4 > 200/µL at first visit	353(95%)	402/445(90.3%)	0.02
CD4 > 200/µL at last visit	352(94.3%)	419/445(94.2%)	0.89
HIV VL < 200 copies/mL at first visit	330(88.5%)	389/448(87%)	0.47
HIV VL < 200copies mL at last visit	337(90.3%)	417/448(93%)	0.15
ARV regimen changes	116 (19)	153(29)	0.32

No competing interests reported.

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Impact of Telehealth in HIV Ambulatory Clinic during COVID-19 Pandemic

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