Background The Health Resources and Services Administration's (HRSA), HIV/AIDS Bureau (HAB) is responsible for leading the nation's efforts to provide health care, medications, and support services ...to low-income people living with HIV through the Ryan White HIV/AIDS Program (RWHAP). The RWHAP funds and coordinates with cities, states, and local community-based organizations to deliver efficient and effective HIV care, treatment, and support services for over half a million vulnerable people living with HIV (PLWH) and their families in the United States. The annual RWHAP Services Report (RSR) is an important source of information for monitoring RWHAP's progress towards National HIV/AIDS Strategy goals. Since 2010, HRSA HAB has used the annual client-level RSR data to monitor program-related outcomes, conduct program evaluations, understand service provision, and conduct extensive analysis on disparities in viral suppression and retention in HIV care. HRSA HAB receives annual RSR submissions from RWHAP recipients and sub-recipients. However, the de-identified nature of the data limits HRSA HAB's ability to expand beyond year-to-year analyses and conduct additional analyses to evaluate outcomes for clients who are seen in multiple years. The current paper describes the development and validation of a method to link RSR client-level records across multiple data years. Methods and findings Using seven RSR reporting years of data (2010 to 2016), we applied a Fellegi-Sunter (F-S) linkage model that used client demographic characteristics and their providers' geographic locations to calculate matching weights for each record pair based on estimated agreement and disagreement conditional probabilities across RSR years. To validate our methodology, we conducted an internal sample review and external validation to assess the level of accuracy of the linkage, and the extent to which the linked data set corresponds accurately to clinical records of individual clients. The linkage result yielded 70 to 80 percent year-to-year client carry-over rate over seven years of the RSR data; 96 percent linkage ratio from the internal sample review and 79.9 to 94.2 percent of provider network client carry- over rate per year from the external validation. Conclusions This methodology addresses a gap in data analysis capabilities by allowing HRSA HAB to link RWHAP clients across reporting years. Despite weak identifying information and lack of continuity of service reporting, the longitudinal linkage improves HRSA HAB's ability to evaluate the patterns of viral suppression and monitor service utilization over time for individuals who receive services in multiple years. These analyses will support future analytic activities in understanding the impact and outcomes of the RWHAP, and will assist HRSA HAB in monitoring progress toward meeting National HIV/AIDS Strategy goals. For those looking for ways to assess health services data, the F-S unsupervised method combining weak identifying attributes and geographic proximity offers practical solutions to the problem of linking de-identified information about individuals across multiple years and improving longitudinal research.
It would be of enormous public health importance if diet and physical activity, both modifiable behavioral factors, were causally related to cancer. Nevertheless, the nutritional epidemiology of ...cancer remains problematic, in part because of persistent concerns that standard questionnaires measure diet and physical activity with too much error. We present a new strategy for addressing this measurement error problem. First, as background, we note that food frequency and physical activity questionnaires require respondents to report "typical" diet or activity over the previous year or longer. Multiple 24-hour recalls (24HR), based on reporting only the previous day's behavior, offer potential cognitive advantages over the questionnaires, and biomarker evidence suggests the 24-hour dietary recall is more accurate than the food frequency questionnaire. The expense involved in administering multiple 24 HRs in large epidemiologic studies, however, has up to now been prohibitive. In that context, we suggest that Internet-based 24 HRs, for both diet and physical activity, represent a practical and cost-effective approach for incorporating multiple recalls in large epidemiologic studies. We discuss (1) recent efforts to develop such Internet-based instruments and their accompanying software support systems; (2) ongoing studies to evaluate the feasibility of using these new instruments in cohort studies; (3) additional investigations to gauge the accuracy of the Internet-based recalls vis-à-vis standard instruments and biomarkers; and (4) new statistical approaches for combining the new instruments with standard assessment tools and biomarkers The incorporation of Internet-based 24 HRs into large epidemiologic studies may help advance our understanding of the nutritional determinants of cancer.
The Health Resources and Services Administration's (HRSA), HIV/AIDS Bureau (HAB) is responsible for leading the nation's efforts to provide health care, medications, and support services to ...low-income people living with HIV through the Ryan White HIV/AIDS Program (RWHAP). The RWHAP funds and coordinates with cities, states, and local community-based organizations to deliver efficient and effective HIV care, treatment, and support services for over half a million vulnerable people living with HIV (PLWH) and their families in the United States. The annual RWHAP Services Report (RSR) is an important source of information for monitoring RWHAP's progress towards National HIV/AIDS Strategy goals. Since 2010, HRSA HAB has used the annual client-level RSR data to monitor program-related outcomes, conduct program evaluations, understand service provision, and conduct extensive analysis on disparities in viral suppression and retention in HIV care. HRSA HAB receives annual RSR submissions from RWHAP recipients and sub-recipients. However, the de-identified nature of the data limits HRSA HAB's ability to expand beyond year-to-year analyses and conduct additional analyses to evaluate outcomes for clients who are seen in multiple years. The current paper describes the development and validation of a method to link RSR client-level records across multiple data years. Using seven RSR reporting years of data (2010 to 2016), we applied a Fellegi-Sunter (F-S) linkage model that used client demographic characteristics and their providers' geographic locations to calculate matching weights for each record pair based on estimated agreement and disagreement conditional probabilities across RSR years. To validate our methodology, we conducted an internal sample review and external validation to assess the level of accuracy of the linkage, and the extent to which the linked data set corresponds accurately to clinical records of individual clients. The linkage result yielded 70 to 80 percent year-to-year client carry-over rate over seven years of the RSR data; 96 percent linkage ratio from the internal sample review and 79.9 to 94.2 percent of provider network client carry- over rate per year from the external validation. This methodology addresses a gap in data analysis capabilities by allowing HRSA HAB to link RWHAP clients across reporting years. Despite weak identifying information and lack of continuity of service reporting, the longitudinal linkage improves HRSA HAB's ability to evaluate the patterns of viral suppression and monitor service utilization over time for individuals who receive services in multiple years. These analyses will support future analytic activities in understanding the impact and outcomes of the RWHAP, and will assist HRSA HAB in monitoring progress toward meeting National HIV/AIDS Strategy goals. For those looking for ways to assess health services data, the F-S unsupervised method combining weak identifying attributes and geographic proximity offers practical solutions to the problem of linking de-identified information about individuals across multiple years and improving longitudinal research.
Oncology patient navigators help individuals overcome barriers to increase access to cancer screening, diagnosis, and timely treatment. This study, part of a randomized intervention trial ...investigating the efficacy of patient navigation in increasing colonoscopy completion, examined navigators' activities to ameliorate barriers to colonoscopy screening in a medically disadvantaged population.
This study was conducted from 2012 through 2014 at Boston Medical Center. We analyzed navigator service delivery and survey data collected on 420 participants who were navigated for colonoscopy screening after randomization to this intervention. Key variables under investigation included barriers to colonoscopy, activities navigators undertook to reduce barriers, time navigators spent on each activity and per contact, and patient satisfaction with navigation services. Descriptive analysis assessed how navigators spent their time and examined what aspects of patient navigation were most valued by patients.
Navigators spent the most time assessing patient barriers/needs; facilitating appointment scheduling; reminding patients of appointments; educating patients about colorectal cancer, the importance of screening, and the colonoscopy preparation and procedures; and arranging transportation. Navigators spent an average of 44 minutes per patient. Patients valued the navigators, especially for providing emotional/peer support and explaining screening procedures and bowel preparation clearly.
Our findings help clarify the role of the navigator in colonoscopy screening within a medically disadvantaged community. These findings may help further refine the navigator role in cancer screening and treatment programs as facilities strive to effectively and efficiently integrate navigation into their services.
Nirmatrelvir/ritonavir (N/R) reduces severe outcomes from coronavirus disease 2019 (COVID-19); however, rebound after treatment has been reported. We compared symptom and viral dynamics in ...individuals with COVID-19 who completed N/R treatment and similar untreated individuals.
We identified symptomatic participants who tested severe acute respiratory syndrome coronavirus 2-positive and were N/R eligible from a COVID-19 household transmission study. Index cases from ambulatory settings and their households contacts were enrolled. We collected daily symptoms, medication use, and respiratory specimens for quantitative polymerase chain reaction for 10 days during March 2022-May 2023. Participants who completed N/R treatment (treated) were propensity score matched to untreated participants. We compared symptom rebound, viral load (VL) rebound, average daily symptoms, and average daily VL by treatment status measured after N/R treatment completion or 7 days after symptom onset if untreated.
Treated (n = 130) and untreated participants (n = 241) had similar baseline characteristics. After treatment completion, treated participants had greater occurrence of symptom rebound (32% vs 20%; P = .009) and VL rebound (27% vs 7%; P < .001). Average daily symptoms were lower among treated participants without symptom rebound (1.0 vs 1.6; P < .01) but not statistically lower with symptom rebound (3.0 vs 3.4; P = .5). Treated participants had lower average daily VLs without VL rebound (0.9 vs 2.6; P < .01) but not statistically lower with VL rebound (4.8 vs 5.1; P = .7).
Individuals who completed N/R treatment experienced fewer symptoms and lower VL but rebound occured more often compared with untreated individuals. Providers should prescribe N/R, when indicated, and communicate rebound risk to patients.
The aim of the study was to increase participation in cervical cancer screening of under-screened women living in the Mississippi Delta, a U.S. population at high risk for cervical cancer.
We ...conducted a door-to-door feasibility study of women living in the Mississippi Delta to increase participation in cervical cancer screening in 2009–10. Women (
n
=
119) aged 26–65
years who had not been screened in last 3
years or more, were not pregnant, and had a cervix were offered a cost-free choice: clinic-based Pap testing or home self-collection with HPV DNA testing.
Seventy-seven women (64.7%) chose self-collection with HPV testing, of which sixty-two (80.5%) returned their self-collected specimen. By comparison, 42 women (35.3%) chose Pap testing, of which 17 (40.5%) attended their clinic appointment. Thus there was an almost 4-fold greater participation of under-screened women in self-collection with HPV testing than in free Pap testing (78.4% vs. 21.5%).
We found that offering self-collection will increase participation in cervical cancer screening among under-screened populations living in the Mississippi Delta. Based on these preliminary results, we suggest that self-collection with HPV DNA testing might complement current Pap testing programs to reach under-screened populations of women, such as those living in the Mississippi Delta.
Colorectal cancer is the second leading cause of cancer mortality among those cancers affecting both men and women. Screening is known to reduce mortality by detecting cancer early and through ...colonoscopy, removing precancerous polyps. Only 58.6% of adults are currently up-to-date with colorectal cancer screening by any method. Patient navigation shows promise in increasing adherence to colorectal cancer screening and reducing health disparities; however, it is a complex intervention that is operationalized differently across institutions. This article describes 10 key considerations in designing a patient navigation intervention for colorectal cancer screening based on a literature review and environmental scan. Factors include (1) identifying a theoretical framework and setting program goals, (2) specifying community characteristics, (3) establishing the point(s) of intervention within the cancer continuum, (4) determining the setting in which navigation services are provided, (5) identifying the range of services offered and patient navigator responsibilities, (6) determining the background and qualifications of navigators, (7) selecting the method of communications between patients and navigators, (8) designing the navigator training, (9) defining oversight and supervision for the navigators, and (10) evaluating patient navigation. Public health practitioners can benefit from the practical perspective offered here for designing patient navigation programs.
Abstract
Background
Understanding the transmissibility of respiratory viruses by symptoms is important for public health.
Methods
Persons who tested positive for SARS-CoV-2 and their household ...contacts (HHC) were recruited from 7 US sentinel sites or by remote invitation nationwide during Sep. 2021—Mar. 2023. The household primary case was the person with the earliest symptom onset or positive test. Starting ≤6 days after primary case onset, primary cases and HHC completed symptom logs (daily, retrospective since onset and for 10 days post-enrollment) and collected nasal or saliva specimens (daily for 10 days) that were tested by RT-PCR. Infected individuals were counted as having developed fever, lower respiratory symptoms (LRS: wheezing, chest tightness/pain, shortness of breath, cough), other symptoms (fatigue, aches, abdominal pain, diarrhea, vomiting, change of taste/smell, headache, sore throat, runny nose, nasal congestion), or as being asymptomatic based on all logs. Risk of secondary infection (any PCR positivity) among eligible, tested HHC (Methods 1) by symptoms of primary cases was estimated using Poisson regression with generalized estimating equations. We estimated days from onset to last PCR positive in a survival model.
Methods upload 1. Enrolled and analytically included household members in case-ascertained studies of household transmission of SARS-CoV-2, United States, Sept 2021 - Mar 2023.
Results
This analysis included 842 households (839 primary cases, 836 infected HHC, and 615 uninfected HHC, median household size of 2). Most primary cases (99%) and infected HHC (81%) were symptomatic (Results 1). Primary cases had higher frequencies of fever or LRS than infected HHC (Results 2). HHC exposed to primary cases who developed fever or LRS were more likely to become infected than HHC exposed to primary cases who did not have fever or LRS (Results 3). Post-hoc comparisons by individual symptoms supported this for fever and all LRS but chest pain (fever: IRR 1.31 95% CI: 1.13-1.52; cough: IRR 1.54 95% CI 1.21 – 1.95; wheezing: IRR 1.20 95% CI 1.08 – 1.35; shortness of breath IRR 1.15, 95% CI 1.04 – 1.27). Primary cases with fever or LRS were PCR positive for a median of 14 days (95% CI: 14 – 15) post-onset, compared to 10 days (95% CI: 9 – 11) for cases who did not have fever or LRS.
Results upload 1. Characteristics of included household members in case-ascertained studies of household transmission of SARS-CoV-2, United States, Sep 2021 - Mar 2023.
Results upload 2. Proportion of primary cases and infected household contacts who experienced individual symptoms.
Results upload 3. Unadjusted and adjusted risk of household contacts becoming infected with SARS-CoV-2, by symptoms in the primary case.
Conclusion
Contacts of primary cases with fever or lower respiratory symptoms may have been more likely to become infected than contacts of primary cases without, suggesting higher transmissibility.
Disclosures
Joshua Petrie, PhD, CSL Seqirus: Grant/Research Support Yvonne A. Maldonado, MD, Pfizer: Grant/Research Support|Pfizer: Site Investigator, DSMB member Suchitra Rao, MBBS, MSCS, Sequiris: Advisor/Consultant Edward Belongia, MD, Seqirus: Grant/Research Support Huong McLean, PhD, MPH, Seqirus: Grant/Research Support Edwin J. Asturias, MD, Hillevax: Advisor/Consultant|Moderna: Advisor/Consultant|Pfizer: Grant/Research Support Carlos G. Grijalva, MD, MPH, AHRQ: Grant/Research Support|CDC: Grant/Research Support|FDA: Grant/Research Support|Merck: Advisor/Consultant|NIH: Grant/Research Support|Syneos Health: Grant/Research Support
Abstract
Background
Nirmatrelvir/ritonavir (N/R) protects against severe outcomes after SARS-CoV-2 (SCV2) infection, but patients and studies have described symptom and viral rebound after treatment. ...Our aim was to compare symptom and viral trajectories during acute illness among individuals with COVID-19 treated with N/R compared to similar individuals who did not receive any COVID-19 treatment.
Methods
This analysis included participants enrolled ≤ 6 days of index symptom onset in a US household transmission study who tested SCV2-positive, Mar. 2022–Mar. 2023. We followed participants for 10 days after enrollment, obtaining demographics, clinical history, daily symptoms (list of 15), medications, and specimens for SCV2 quantitative PCR. Symptomatic participants eligible for N/R were included (Fig. 1). We used propensity score matching to select untreated participants who were similar to N/R treated participants (Table 1). We assessed symptoms and viral load (when ≥ 2 nasal swab results were available) from N/R completion (N/R treated) or after seven days since symptom onset (untreated) to the end of follow up. We defined symptom rebound as an increase of ≥ 2 symptoms and viral load rebound as an increase of ≥ 0.5 log10(IU/mL) over a minimum of 5 log10(IU/mL). We used Wilcoxon Test to compare mean daily symptoms and viral loads and logistic regression to calculate odds of rebound.
Case-ascertained household transmission study participants were included in this analysis if they were enrolled in March 2022 (first report of nirmatrelvir/ritonavir) or after and tested positive for SARS-CoV-2 (n=2075). We included symptomatic N/R eligible participants who had non-missing data for propensity score model variables and daily specimens and symptoms (n=1224) and then excluded N/R treated participants who did not complete N/R in 5-6 days according to EUA (n=108). Propensity score matching was performed by calculating propensity score of nirmatrelvir/ritonavir use based on age, sex, race/ethnicity, prior COVID-19, recruitment method, participant type, medical care access, COVID-19 vaccination history, comorbidities, and predominant variant at the time of index onset. The best covariate balance was achieved using nearest propensity score matching method with a ratio of 2:1 no treatment to N/R treated. Those that did not match to a treated participant were excluded (n=768). The two recruitment sources collected different specimen types (sentinel sites collected nasal swabs and remote recruitment collected saliva) and used different viral load quantification standards. Because of this, viral load analysis was limited to only those that collected nasal swabs and had at least two viral load results after nirmatrelvir/ritonavir completion or, for the no treatment participants, after day 7 since symptom onset. N/R=nirmatrelvir/ritonavir; SCV2=SARS-CoV-2; EUA=Emergency Use Agreement
Results
N/R treated (n=116) and untreated (n=232) participants had similar baseline characteristics (Table 1). Median days from symptom onset to N/R initiation was 2 days (IQR=1-3). Symptom rebound occurred among 32% of N/R treated and 19% of untreated participants (OR=1.95; 95% CI=1.17, 3.24; Fig. 2). Mean daily symptoms were lower among N/R treated (1.6 vs 2.0; p=0.2) and significantly lower among N/R treated when rebound did not occur (0.8 vs 1.5; p=0.01). Viral load rebound occurred among 25% of N/R treated and 13% of untreated participants (OR=2.31; 95% CI=1.17, 4.55) and mean daily viral load was significantly lower among N/R treated overall (1.5 vs 2.7), without rebound (1.1 vs 2.5), and with rebound (4.8 vs 5.6, all p < 0.05, Fig. 3).
The following symptoms were elicited daily from participants: fever/feverish/chills, cough, sore throat, runny nose, nasal congestion, fatigue/feeling run down, wheezing, trouble breathing/shortness of breath, chest tightness/chest pain, loss of smell/loss of taste, headache, abdominal pain, diarrhea, vomiting, and muscle or body aches. Symptom rebound was defined as an increase of at least two symptoms after the completion of nirmatrelvir/ritonavir or, when no treatment was reported, after seven days since symptom onset. Daily symptoms after end of treatment were averaged from the day after the last day of nirmatrelvir/ritonavir or, if no treatment, day eight since symptom onset to the last available symptom diary follow up. N/R=nirmatrelvir/ritonavirFigure 3.Viral load trajectory during the first two weeks after symptom onset by nirmatrelvir/ritonavir treatment and viral load rebound visualized by (A) median viral load each day since symptom onset and proportion with viral load rebound and (B) average daily viral load after nirmatrelvir/ritonavir completion or seven days since symptom onset
Nasal swabs were tested for SARS-CoV-2 by PCR using the Panther Fusion Hologic system. Viral load as logIU/mL was determined using WHO standard. Negative results were set to zero and below limit of quantification (3 logIU/mL) results were set to 1.5 logIU/mL. Viral load rebound was defined as an increase of at least 0.5 logIU/mL (with a threshold of 5 logIU/mL) after the completion of nirmatrelvir/ritonavir or, if no treatment was reported, after seven days since symptom onset. Daily viral load after end of treatment was averaged from the day after the last day of nirmatrelvir/ritonavir or, if no treatment, day eight since symptom onset to the last available viral load result. N/R=nirmatrelvir/ritonavir; IU=international units
Conclusion
In outpatient settings, N/R treated individuals had fewer symptoms and lower viral loads, but greater odds of symptom and viral rebound compared to similar untreated individuals.
Disclosures
Joshua Petrie, PhD, CSL Seqirus: Grant/Research Support Suchitra Rao, MBBS, MSCS, Sequiris: Advisor/Consultant Edward Belongia, MD, Seqirus: Grant/Research Support Edwin J. Asturias, MD, Hillevax: Advisor/Consultant|Moderna: Advisor/Consultant|Pfizer: Grant/Research Support Huong McLean, PhD, MPH, Seqirus: Grant/Research Support Yvonne A. Maldonado, MD, Pfizer: Grant/Research Support|Pfizer: Site Investigator, DSMB member Carlos G. Grijalva, MD, MPH, AHRQ: Grant/Research Support|CDC: Grant/Research Support|FDA: Grant/Research Support|Merck: Advisor/Consultant|NIH: Grant/Research Support|Syneos Health: Grant/Research Support
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