Background
Methods
Study design
Study population
Recruitment
Mobile application
Self-testing methods and quantitative data collection
Reference testing
Compensation
Data analysis
Results
Participant recruitment and study completion rates
Description of participants, risk factors for influenza, and symptoms
Characteristics N (%) | Overall (N = 739) | PCR+ (N = 43) | PCR- (N = 696) | p-value |
---|---|---|---|---|
Demographics | ||||
Age | ||||
18 to 24 | 86 (11.6) | 0 (0) | 86 (12.4) | 0.002 |
25 to 34 | 202 (27.3) | 12 (27.9) | 190 (27.3) | |
35 to 44 | 191 (25.8) | 19 (44.2) | 172 (24.7) | |
45 to 64 | 203 (27.5) | 12 (27.9) | 191 (27.4) | |
65 and older | 57 (7.7) | 0 (0) | 57 (8.2) | |
Sex (n = 736) | ||||
Female | 584 (79.0) | 35 (81.4) | 549 (78.9) | 0.865 |
Male | 150 (20.3) | 8 (18.6) | 142 (20.4) | |
Other | 2 (0.3) | 0 (0) | 2 (0.3) | |
Race (n = 730) | ||||
White | 539 (73.0) | 35 (81.4) | 504 (72.4) | 0.289 |
Black | 59 (8.0) | 1 (2.3) | 58 (8.3) | |
Asian | 62 (8.4) | 2 (4.7) | 60 (8.6) | |
Native (American Indian, Alaska Native, native Hawaiian) | 6 (0.8) | 0 (0) | 6 (0.9) | |
Other | 30 (4.1) | 4 (9.3) | 26 (3.7) | |
Mixed race | 34 (4.6) | 1 (2.3) | 33 (4.7) | |
Ethnicity (Hispanic or Latino) (n = 733) | ||||
No | 654 (88.5) | 38 (88.4) | 616 (88.5) | 1.0 |
Yes | 79 (10.7) | 4 (9.3) | 75 (10.8) | |
Exposure or Risk Factor | ||||
Health Insurance (n = 737) | ||||
Government | 252 (34.1) | 14 (32.6) | 238 (34.2) | 0.963 |
No Insurance | 58 (7.8) | 3 (6.9) | 55 (7.9) | |
Private | 427 (57.8) | 26 (60.5) | 401 (57.6) | |
Received flu shot in the last year (n = 715) | ||||
No | 359 (48.6) | 21 (48.8) | 338 (48.6) | 0.977 |
Yes | 356 (48.2) | 22 (51.2) | 334 (47.9) | |
Currently smokes tobacco (n = 734) | ||||
No | 600 (81.2) | 39 (90.7) | 561 (80.6) | 0.172 |
Yes | 134 (18.1) | 4 (9.3) | 130 (18.7) | |
Currently taking antibiotics or antivirals (n = 729) | ||||
No | 608 (82.3) | 32 (74.4) | 576 (82.5) | 0.149 |
Yes | 121 (16.4) | 11 (25.6) | 110 (15.8) | |
Contact with a person who seemed to have a cold in the past week (n = 734) | ||||
Don’t know | 184 (24.9) | 9 (20.9) | 175 (25.1) | |
No | 109 (14.7) | 8 (18.6) | 101 (14.5) | 0.735 |
Yes | 441 (59.7) | 26 (60.5) | 415 (59.6) | |
If yes to contact with a sick person did they have a cough or sneeze (n = 441) | ||||
Don’t know | 15 (3.4) | 1 (3.4) | 14 (3.4) | |
No | 14 (3.2) | 3 (11.5) | 11 (2.6) | 0.039 |
Yes | 406 (92.0) | 21 (80.8) | 385 (92.8) | |
Current illness interferes with daily activity (n = 737) | ||||
No | 230 (31.1) | 4 (9.3) | 226 (32.5) | 0.002 |
Yes | 507 (68.6) | 39 (90.7) | 468 (67.2) |
Symptoms N (%) | Overall (N = 739) | PCR + (N = 43) | PCR – (N = 696) | p-value |
---|---|---|---|---|
Fatigue | 686 (92.5) | 42 (97.7) | 644 (92.5) | 0.334 |
Cough | 671 (90.8) | 42 (97.7) | 629 (90.4) | 0.163 |
Runny Nose | 657 (88.9) | 39 (90.7) | 618 (88.8) | 0.892 |
Headache | 615 (83.2) | 35 (81.4) | 580 (83.4) | 0.904 |
Muscle or Body Aches | 581 (78.6) | 37 (86.1) | 544 (78.2) | 0.301 |
Sore throat | 570 (77.1) | 35 (81.0) | 535 (76.9) | 0.617 |
Chills or Sweat | 518 (70.1) | 41 (95.4) | 477 (68.5) | 0.0003 |
Fever | 440 (59.3) | 37 (86.1) | 403 (57.9) | 0.0004 |
Shortness of Breath | 333 (45.1) | 25 (58.1) | 308 (44.2) | 0.105 |
Timing of illness and completion of study procedures
N (%) | Overall (N = 739) | PCR+ (N = 43) | PCR- (N = 696) | p-value |
---|---|---|---|---|
Number of days between ordering a test kit, shipping/delivery, and beginning testing procedures at home | ||||
No data | 28 (3.8) | 2 (4.7) | 26 (3.7) | 0.191 |
0–1 day | 171 (23.1) | 10 (23.3) | 161 (23.2) | |
2 days | 303 (41.0) | 23 (53.4) | 280 (40.3) | |
3 days | 88 (11.9) | 4 (9.3) | 84 (11.9) | |
4 days | 55 (7.4) | 3 (6.9) | 52 (7.5) | |
5–40 days | 94 (12.7) | 1 (2.3) | 93 (13.4) | |
Number of days from starting test procedure at home to receipt of reference sample at the study laba | ||||
No data | 1 (0.1) | 0 | 1 (0.1) | 0.2183 |
0–1 days | 9 (1.2) | 1 (2.3) | 8 (1.1) | |
2 days | 96 (12.9) | 8 (18.6) | 88 (12.7) | |
3 days | 176 (23.8) | 7 (16.3) | 169 (24.2) | |
4 days | 168 (22.7) | 14 (32.6) | 154 (22.2) | |
5–28 days | 289 (39.1) | 13 (30.2) | 276 (39.7) |
Self-reported errors in test performance and errors in reference test return
Accuracy of self-test
True positive | False positive | True negative | False negative | Sensitivity (95%CI) | Specificity (95%CI) | PPV (95%CI) | NPV (95%CI) | |
---|---|---|---|---|---|---|---|---|
Participant interpretation of self-test | 6 | 68 | 603 | 37 | 0.14 (0.05, 0.28) | 0.90 (0.87, 0.92) | 0.08 (0.03, 0.17) | 0.94 (0.92, 0.96) |
Expert interpretation of image of self-test | 5 | 7 | 637 | 38 | 0.12 (0.04, 0.25) | 0.99 (0.98, 1.00) | 0.42 (0.15, 0.25) | 0.94 (0.92, 0.96) |
Discussion
Main findings
Comparison to existing literature
Lessons learned
Study Design Feature | Advantages | Disadvantages |
---|---|---|
Integrated study functions streamlined into a mobile application | • Reduced resources needed for recruitment • Efficiency in expanding geographic reach • Maintained protocol standardization between participants • Single interface which simplified study procedures and aided participant engagement (e.g. participant took the study questionnaire while they waited for the test results) | • Resources needed to develop app • No human interaction with risks to study fidelity: ➜ Unable to verify accuracy of self-reported responses ➜ Difficult to verify if participants conducted the swabbing correctly without marker of human DNA |
Recruitment using online marketing through social media | • Expanded geographic reach • Ability to target specific groups and regions • Improves generalizability (people in the community versus recruitment in a clinic seeking care) • Facilitates tailoring of recruitment materials compared to paper based recruitment materials | • Can be expensive • Financial incentives noted in online recruitment can attract participants only interested in financial reward • Avoid recruitment materials that advertise monetary incentive |
Determining eligibility through Self-reported symptoms | • Prevents exposure of study staff to ILI | • Unable to verify eligibility information provided by the participant • We accepted participants with ILI symptoms longer than 72 h |
Shipping of test kit to and from study lab | • Prevents exposure of ILI to study staff and potentially people at a health care clinic • Central distribution of study kits allowed for quality control | • Despite priority and overnight shipping, shipping and time to participants taking the test took too long to capture many participants early in their illness |
Return of reference sample | • Facilitated reference sampling, without need for study staff or clinic visits • Low error rate and participants reported that it was easy to collect | • Study design did not stress rapid return of the sample thus lead to longer times to return to study lab and spoiled UTM fluid • Time of the year/temperature may impact UTM fluid stability |