Abstract
Objectives
Hepatitis C virus (HCV) infection is a serious health problem in New York City. Although curative treatments are available, many people are out of care. The New York City Department of Health and Mental Hygiene (DOHMH) used surveillance data and various outreach methods to attempt to link to care people diagnosed with HCV infection from 2010 through 2015.
Methods
We randomly assigned people out of care (ie, no HCV test >6 months after first report) to 4 outreach groups: no outreach (control group); letter only; letter and telephone call; and letter, text message, and telephone call. Three months after outreach ended, we analyzed surveillance data to identify people with a subsequent HCV RNA or genotype test suggesting linkage to care.
Results
Of 2626 selected people, 199 (7.6%) had a subsequent HCV test. People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]). People in the letter and telephone group had higher odds of a subsequent test than people in the letter-only group (aOR = 1.72; 95% CI, 1.04-2.74). Most people in the letter and telephone (136/200, 68.0%) and the letter, text, and telephone (71/99, 71.7%) groups could not be reached, primarily because telephone numbers were incorrect or out of service.
Conclusion
Reaching out to people soon after first report or prioritizing groups in which more recent contact information can be found might improve outcomes of future outreach.
Hepatitis C virus (HCV) infection affects more than 2.4 million people in the United States and at least 116 000 people in New York City. 1,2 Chronic HCV infection can lead to cirrhosis, liver cancer, and premature death. 3,4 Since 2013, medications have been available that cure HCV infection among almost all people, with limited side effects. 5 With improved options for cure, increased emphasis has been placed on finding people with HCV infection, linking them to care, and treating them. However, in New York City alone, more than half of people with a positive HCV test result were estimated to have not started treatment by the end of 2016. 6
Despite the availability of effective treatment for HCV infection, many people diagnosed with HCV infection are not in care. 7 -9 However, linking people to care can help engage them in treatment. 10,11 Health departments or other organizations wishing to help link people with HCV infection to care might consider various approaches depending on available resources and capacity, such as sending letters, making telephone calls, sending text messages, or conducting community-based case finding. Sending letters can reach a large number of people relatively quickly, and telephone calls allow for tailored guidance and advice. 12 Similarly, text messaging is increasingly being used to contact people for health-related issues, 13,14 although texting alone might not be enough to increase the number of people retained in care. 15
To evaluate the effectiveness and feasibility of health department–delivered direct linkage-to-care outreach to people with HCV infection, the New York City Department of Health and Mental Hygiene (DOHMH) compared various combinations of sending letters, making telephone calls, and sending text messages to increase subsequent RNA testing. We randomized people diagnosed with chronic HCV infection from January 1, 2010, through December 31, 2015, but seemingly out of care into 4 groups: (1) no outreach (control group); (2) letter only; (3) letter and telephone call (hereinafter, letter and telephone); and (4) letter, text message, and telephone call (hereinafter, letter, text, and telephone). We evaluated whether outreach increased the proportion of people receiving subsequent RNA or genotype testing compared with no outreach; whether particular outreach methods or combinations of outreach methods were more effective than others; and the ability of DOHMH to reach people with contact information that might be outdated.
Methods
Participant Selection and Randomization
In New York City, tests for HCV infection, including positive antibody tests and positive and negative RNA tests, are reportable to DOHMH and are received through routine electronic reporting from laboratories. We selected people who first had an HCV test result reported to DOHMH from January 1, 2010, through December 31, 2015, at least 1 positive RNA test, no negative RNA or genotype tests, and no reported HCV test result >6 months after their first report and, therefore, were considered out of care. We randomized these people to 1 of 3 outreach groups or a control group. In addition, eligible people were those who were not known to be deceased (from matching to death certificate records or past investigation), were aged ≥18 at sampling (January 2017), and had a valid New York City home address associated with their last reported test that was verified by the US Postal Service. Invalid addresses included addresses of hospitals, health care provider offices, or correctional facilities and addresses listed as unknown or undomiciled.
We randomized 2626 eligible people: 500 people to the control group and the remaining 2126 people into 3 outreach groups: letter only (n = 1827), letter and telephone (n = 200), and letter, text, and telephone (n = 99). We chose the sizes of the letter and telephone group and letter, text, and telephone group for feasibility based on available resources. We required that people randomized to the letter and telephone group have a telephone number and that people in the letter, text, and telephone group have a cell phone number. We did not consider telephone numbers that were seemingly invalid (eg, 000-000-0000 or similar) during randomization. We identified cell phone numbers using Interactive Marketing Solution files, a subscription service primarily used to identify and exclude cell phone numbers in marketing calls. 16,17 Of 500 people in the control group, 359 (71.8%) had a telephone number and 188 (37.6%) had a cell phone number. Of 1827 people in the letter-only group, 1206 (66.0%) had a telephone number and 577 (31.6%) had a cell phone number.
Methods of Outreach
We mailed a letter in February 2017 to people in all groups except the control group. The letter informed people of their positive HCV test result, provided facts on HCV infection, and provided a list of New York City facilities where they could receive HCV-related care and treatment. We included a DOHMH telephone number so that recipients could call if they had additional questions or needed support. We tracked letters returned as undeliverable; in March 2017, we re-mailed letters returned with a New York City forwarding address.
For people in the letter and telephone group and those in the letter, text, and telephone group, DOHMH health care access specialists (HCASs) attempted additional contact. We excluded people who received an HCV RNA or genotype test after the letters were sent from additional outreach because it was assumed that linkage had occurred. People in the letter and telephone group received a telephone call from the HCAS from June 1 through October 31, 2017. The HCAS reinforced the information contained in the letter and offered assistance with contacting an HCV care provider by providing motivation, assisting with scheduling appointments, and providing appointment reminders if requested. The HCAS referred patients to providers based on their preference and attempted to refer them to organizations that provided appropriate services and agreed to accept referrals. The HCAS attempted to contact people by telephone up to 5 times, including leaving 1 voice mail message, before closing the case as unreachable.
We first sent up to 2 text messages, 2 days to 1 week apart, to people in the letter, text, and telephone group requesting that the recipient contact DOHMH. Per DOHMH policy, the text message could not contain any disease-specific information. The initial text message read: “The Health Department has important information about your health, call ____ at xxx-xxx-xxx to learn more,” and it included the name and telephone number of an HCAS. Text messages included the opportunity to reply STOP to opt out of receiving further messages. HCASs followed up with a telephone call if people did not respond to the text message and/or if no HCV test was performed after receipt of the text message. People who either called back or were called by the HCAS after the text message received similar services to people in the letter and telephone group.
Outcomes and Data Analysis
We summarized demographic characteristics available through routinely reported surveillance data. In addition, we calculated neighborhood poverty level using zip code of residence at last report. We defined neighborhood poverty level as the percentage of residents in a given zip code whose incomes were <100% of the federal poverty level, based on the American Community Survey 18 corresponding to each person’s year of last reported test.
We assessed surveillance data to determine if people in all 4 groups had a subsequent RNA (qualitative or quantitative) or genotype test from 2 days after the letter was mailed until 3 months after the last telephone call was completed (January 2018). To evaluate the odds of a subsequent RNA or genotype test by outreach group, we used Firth penalized likelihood logistic regression models to calculate odds ratios (ORs) and profile likelihood confidence intervals (CIs) comparing each outreach group with the control group, as well as for pairwise comparisons among the outreach groups. We adjusted ORs for year of first report, year of birth, sex, and neighborhood poverty level. We calculated the same measures using a per-protocol approach, in which we included in the analysis only people who received the outreach as intended. We considered ORs significant if the CIs did not include 1.
In addition to the primary outcome, we examined additional outcomes related to the success of the outreach methods by group, including the proportion of letters returned to DOHMH and outcomes of attempted telephone calls. We performed statistical analysis by using SAS Enterprise Guide version 7.13 (SAS Institute Inc). The DOHMH Institutional Review Board reviewed and approved this study.
Results
Of 2626 participants, 1639 (62.4%) were male (Table 1). About half (n = 1317, 50.2%) of selected people were born during 1945-1965 (baby boomers). Most participants resided in high- or very high–poverty neighborhoods (n = 1489, 56.7%). A lower percentage of participants born before 1945 were in the letter, text, and telephone group (9/99, 9.1%) than in the control or other intervention groups (range, 16.4%-23.0%). A lower percentage of participants diagnosed in 2010 were in the letter, text, and telephone group (6/99, 6.1%) than in the control or other intervention groups (range, 14.3%-14.8%).
Demographic characteristics of people reported to the New York City Department of Health and Mental Hygiene with hepatitis C virus infection during 2010-2015 and appearing out of care who were randomly selected for linkage-to-care outreach a
aData source: Unpublished data, New York City Department of Health and Mental Hygiene.
bNeighborhood poverty level was defined as the percentage of the population residing in a zip code living at <100% of the federal poverty level and was calculated by using the American Community Survey 5-year file 18 centered on individual’s year of last report.
Outreach Attempts and Linkage-to-Care Services Provided
Of the 2126 people who were mailed a letter, 684 (32.2%) letters were returned to sender without a forwarding address. The undeliverable rate did not differ substantially by the year of a person’s last report to DOHMH or by outreach group.
We attempted to contact 187 of 200 people in the letter and telephone group and 93 of 99 people in the letter, text, and telephone group (Table 2). After attempting to contact people in the outreach groups, we did not contact 1 person each in the letter and telephone group and the letter, text, and telephone group after identifying that they previously opted out of receiving telephone calls and text messages from DOHMH. In addition, 12 people in the letter and telephone group and 7 people in the letter, text, and telephone group were tested after the letter was sent, and so they did not receive further outreach. HCASs interviewed 25 of 200 (12.5%) people in the letter and telephone group, 14 (56.0%) of whom accepted linkage-to-care services and 11 (44.0%) of whom indicated they were in care, had already cleared their infection, or declined services. Furthermore, 3 people in the letter and telephone group who had moved out of New York City received linkage-to-care services. HCASs interviewed 15 of 99 (15.2%) people in the letter, text, and telephone group, of whom 8 received linkage-to-care services; in addition, 2 people were tested after the text messages were sent but before outreach by telephone was attempted.
Outcomes of people reported to the New York City Department of Health and Mental Hygiene with hepatitis C virus infection during 2010-2015 who appeared out of care and were assigned to receive either a letter and telephone call or a letter, text message, and telephone call to promote linkage to care a
Abbreviation: HCAS, health care access specialist.
aUnpublished data, New York City Department of Health and Mental Hygiene.
bVital status determined during proxy interview with HCAS. Vital status likely under-ascertained.
cOutmigration determined during interview with HCAS. Outmigration likely under-ascertained.
Hepatitis C Testing After Intervention
Overall, 199 of 2626 (7.6%) people received an RNA or genotype test from March 1, 2017, through January 31, 2018. During the follow-up period, 144 (7.9%) of 1827 people in the letter-only group and 23 of 500 (4.6%) people in the control group were tested. Twenty of 200 (10.0%) people in the letter and telephone group and 12 of 99 (12.1%) people in the letter, text, and telephone group were tested during the follow-up period (Table 3). Two people in the letter and telephone group and 1 person in the letter, text, and telephone group were tested but never reached by telephone.
RNA or genotype testing after outreach for people reported to the New York City Department of Health and Mental Hygiene with hepatitis C virus infection during 2010-2015 and who appeared out of care a
Abbreviation: aOR, adjusted odds ratio.
aUnpublished data, New York City Department of Health and Mental Hygiene.
bFirth penalized likelihood logistic regression models, adjusted by year of first report, year of birth, neighborhood poverty level, and sex.
Compared with people in the control group, people in the letter-only (adjusted OR [aOR] = 1.81; 95% CI, 1.18-2.91), letter and telephone (aOR = 3.11; 95% CI, 1.67-5.79), and letter, text, and telephone (aOR = 3.17; 95% CI, 1.48-6.51) groups had higher odds of receiving a subsequent RNA or genotype test when we controlled for year of first report, year of birth, neighborhood poverty level, and sex (Table 3). In the comparison of intervention groups, people who received a letter and telephone call or letter, text, and telephone call had significantly higher odds of having a subsequent RNA or genotype test than people who received a letter only (aOR = 3.57 [95% CI, 1.29-8.85] and aOR = 5.78 [95% CI, 1.98-15.63], respectively) (Table 4).
Pairwise comparisons of RNA or genotype testing after outreach for people reported to the New York City Department of Health and Mental Hygiene with hepatitis C virus infection during 2010-2015 and who appeared out of care a
aData source: Unpublished data, New York City Department of Health and Mental Hygiene.
bFirth penalized likelihood logistic regression models, adjusted by year of first report, year of birth, neighborhood poverty level, and sex.
In the per-protocol approach, we included in the analysis people in the letter-only group who did not have a letter returned to sender (n = 1223), people in the letter and telephone group who were interviewed (n = 25), and people in the letter, text, and telephone group who were either interviewed or had an RNA or genotype test after the initial text message (n = 17). A total of 23 people in the control group, 118 people in the letter-only group, 6 people in the letter and telephone group, and 6 people in the letter, text, and telephone group were subsequently tested (Table 3). People in each outreach group who received their intended intervention had significantly higher adjusted odds of receiving a subsequent RNA or genotype test than people in the control group (letter-only group: aOR = 2.22 [95% CI, 1.43-3.59]; letter and telephone group: aOR = 7.93 [95% CI, 2.68-21.27]; letter, text, and telephone group: aOR = 12.84 [95% CI, 4.15-37.33]) (Table 3). People who received a letter and telephone call had higher odds of receiving a subsequent test than people who received a letter only (aOR = 3.57; 95% CI, 1.29-8.85). People who received a letter, text, and telephone call had higher odds of receiving a test than people who received a letter only (aOR = 5.78; 95% CI, 1.98-15.63) (Table 4).
Discussion
The DOHMH attempted to reach and link to care a large number of people with HCV infection diagnosed during 2010-2015 who appeared to be out of care and in need of treatment using 3 outreach methods—letter, text, and telephone call. We found that linkage to care, measured by the receipt of an HCV RNA or genotype test after outreach, was 7.6% overall, and the odds of testing were higher in the intervention groups than in the control group.
Personalized outreach methods can increase reengagement in care 19 ; in our study, the odds of a subsequent test were highest for the outreach groups that included telephone calls or text messages than in the control group. In the per-protocol analysis, telephone calls with or without text messaging were more effective than a letter alone. However, the gains in the absolute number of people linked to care were small. Of the 200 people in the letter and telephone group and 99 people in the letter, text, and telephone group, only 20 and 12 people, respectively, had a subsequent RNA or genotype test during the follow-up period.
Approximately 70% of people in the letter and telephone and letter, text, and telephone groups could not be interviewed, and 33% of letters were returned to sender. Evidence from an evaluation of immunization reminder efforts suggests that people’s contact information can change quickly, with almost 70% of people changing telephone numbers within an 18-month period. 20 Although we selected people who had a positive HCV test reported more than a year before outreach because these people conceivably were most in need of linkage-to-care services, we may have to adjust this strategy because of the difficulties of trying to reach people with outdated contact information.
However, when people were reached and interviewed, HCASs were successful at providing linkage-to-care services; >50% of people in the letter and telephone and letter, text, and telephone groups received services after the interview. Likewise, the odds of being tested were higher for people in the outreach groups than for people in the control group. In a DOHMH study aiming to reengage people with HIV who appeared out of care, outreach workers reached approximately 100 people per month and provided services to approximately half of people who were reached. 21 The larger proportion reached in that study might be attributable to the greater resources and staff members available for HIV investigation and case finding, including access to internet-based subscription databases to find contact information that is closer to the time of outreach. In addition, the time between being out of care and outreach was shorter in that study than in our study. Increased resources for case finding might have improved our ability to successfully contact people in our registry. However, results of our study indicate that directing efforts to people who have been out of care for many years might not be fruitful at current resource levels. As next steps, approaches that can increase the likelihood of having accurate contact information, such as contacting people who have a more recent hepatitis C test reported to DOHMH or people in priority populations (eg, people with severe fibrosis [identified from regional health information exchanges] or people recently released from jail [referred by correctional health programs]), may yield higher rates of linkage to care.
Limitations
This analysis had several limitations. First, a subsequent RNA or genotype test is only a proxy for linkage to care. The receipt of an HCV test may not indicate that a person will be engaged and retained in HCV-specific care; likewise, a person could have a care visit that does not include an RNA or genotype test. Attendance at a visit for hepatitis C care would be a better measure of linkage to care; however, we do not receive information at health care provider visits. Second, although all groups had the same follow-up time, the timing of additional outreach (ie, telephone calls and/or text messages) occurred at different times during the observation period. Third, all testing information came from the surveillance database, and before 2014, only positive RNA tests were reportable. People diagnosed before 2014 might have had a negative RNA test performed that was not found in the surveillance database; therefore, they would have appeared to need linkage to care even though they might have already been cured or cleared the infection naturally.
Fourth, excluding people without a valid home address could have removed people who may still have been successfully reached by telephone or, conversely, removed people who would be least likely to be reached, such as people who were unstably housed or experiencing homelessness. Fifth, the text message component might not have been as effective as possible, because we were limited by DOHMH privacy policy from texting more personal, specific information. Sixth, the per-protocol analysis assumed that every person whose letter was not returned to sender actually received the letter and opened it as intended.
Seventh, randomization could not be truly random because of the requirement for telephone numbers for 2 outreach groups, including cell phone numbers in one of the groups. Requiring a valid telephone number could have caused differences in the outreach groups and contributed to differences in observed outcomes. However, the number of people during the study period who had telephone numbers was not high enough to require that everyone in all outreach groups, including the letter-only group, have telephone numbers while maintaining adequate sample size. Eighth, we chose the sample sizes for groups including the letter, telephone, and text group for feasibility based on available resources, and the sample sizes might have been too small to detect meaningful differences among groups. Because of the small sample size of each group, the estimates might be unstable, as indicated by the wide CIs. Finally, the number of people with subsequent tests was small, particularly when we used per-protocol analysis; however, we attempted to account for sparse data by using a penalized likelihood logistic regression method.
Conclusions
Our attempt to reach out to people likely not engaged in HCV care for many years and compare 3 methods to link them to care provided valuable lessons. We were unable to contact most people selected for outreach, primarily because of inaccurate or out-of-date contact information. However, outreach was beneficial, and because letters and telephone calls were more successful than letters only, our findings suggest that telephone calls were useful. Although we hoped to reach more people and link them to care, we learned that we can likely not successfully reach most people reported with a positive hepatitis C test several years before investigation, that we should likely focus limited resources on outreach to priority populations, and that we should work to build linkage-to-care capacity in community-based organizations and health centers where people are seeking care. In an era in which treatments are effective, well tolerated, and have the potential to eliminate HCV infection, the need to identify and engage people with HCV in care is more pressing than ever.
Footnotes
Acknowledgments
The authors acknowledge the efforts of Jessie Schwartz and the Viral Hepatitis Program health care access specialists: Alexis Brenes, Caroline Davidson, Natalie Octave, Farma Pene, and Liz Tang. The authors also thank Jennifer Baumgartner for her assistance with data collection and management.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was partially funded through a Gilead FOCUS grant. FOCUS funding supports HIV, hepatitis C virus, and hepatitis B virus screening and linkage to the first medical appointment after diagnosis.
