Abstract
To demonstrate the feasibility and acceptability of mobile point-of-care and near-patient testing for sexually transmissible infections, we offered services during an annual community event and surveyed event-goers. Forty-two participants were tested. When provided with options, the majority of participants chose point-of-care or near-patient testing. Trichomoniasis, chlamydia and gonorrhea were detected. All but one infected participant were notified and prescribed treatment. Participants responding to a written questionnaire reported sample self-collection and testing in a van as acceptable, although men reported self-collection in a van as less acceptable than a doctor's office. Providing mobile point-of-care and near-patient sexually transmitted infection testing to the general population is feasible and acceptable.
Keywords: community outreach, mobile health units, public health
Introduction
The feasibility and acceptability of point-of-care (POC) and non-Clinical Laboratory Improvement Amendment waived, near-patient testing in a mobile setting has not been demonstrated. We sought to demonstrate the feasibility and acceptability of these tests when providing sexually transmissible infection (STI) services at a community event in a metropolitan area with high STI prevalence.1
Methods
Through a community–academic partnership, we provided free STI screening in a mobile health care van at an annual community event to women ≤14 years during Year 1 (2012) and women and men ≤14 years in Year 2. Tests included: OSOM® Rapid Trichomonas Test (Sekisui Diagnostics, Lexington, MA, USA); laboratory-based Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) nucleic acid amplification test;2 near-patient Xpert® CT/NG assay (Cepheid, Sunnyvale, CA, USA)3 (Year 2 only); and Rapid Plasma Reagin syphilis test (Becton, Dickenson and Company Sparks, MD, USA). All specimens were self-collected in the van. Participants with positive results were notified and prescribed treatment. In Year 2, a confidential questionnaire assessed the acceptability of test turnaround times and self-sample collection among visitors to the van.4,5
According to the approved institutional review board protocol, consent for research was not required for testing, except for participants choosing the Cepheid Xpert® CT/NG assay in Year 2, because the van did not have a CLIA licence.
Feasibility measures included STI testing uptake, STI prevalence, and treatment delivery rates. Acceptability was measured on a 5-point Likert-like scale (1 = very acceptable, 5 = very unacceptable).4,5 Differences in acceptability were tested using the Wilcoxon signed-rank test.
Results
The mean age of women was 28 years (range, 16–63 years) in Year 1 (n = 16), and 30 years (range, 14–55 years) in Year 2 (n = 15). The mean age of men (n = 11) was 19 years (range, 14–29 years).
Table 1 shows the number of participants tested by test type and the rate of positive results. Nine infections were detected from seven participants (two women in Year 2 had TV and CT). Six of seven participants (86%) with positive results were prescribed treatment (i.e. prescription or referral given). All participants with positive results from POC testing (TV) and one of two participants with positive results from near-patient testing (CT/NG) were notified the same day and prescribed treatment. One of three participants with positive laboratory-based test results was unable to be contacted.
Table 1.
STI test | Women | Men | ||||
---|---|---|---|---|---|---|
Year 1 | Year 2 | Year 2 | ||||
Number tested, n | Positive, n (%)A | Number tested, n | Positive, n (%)A | Number tested, n | Positive, n (%)A | |
Trichomoniasis, point-of-careB | 16 | 1 (6) | 15 | 3 (20) | n/a | n/a |
ChlamydiaB | ||||||
Laboratory-basedD | 15 | 2 (13) | 2 | 0 | 1 | 0 |
Near-patientE | n/a | n/a | 12 | 2 (17) | 10 | 0 |
GonorrheaC | ||||||
Laboratory-basedD | 15 | 1 (7) | 2 | 0 | 1 | 0 |
Near-patientE | n/a | n/a | 12 | 0 | 10 | 0 |
Syphilis, laboratory-basedD | 15 | 0 | 11F | 0 | 8G | 0 |
AC2, APTIMA Combo 2; n/a, not applicable; STI, sexually transmissible infection
Percentage of the number tested for the specific STI.
Ten-minute turnaround time.
Chlamydia and gonorrhea were offered together.
Two-week turnaround time.
Ninety-minute turnaround time. Near-patient testing was only offered in Year 2. Confirmation testing for all near-testing results with AC2 had exact agreement for all samples.
Of the 12 requesting testing, only 11 received testing due to failed phlebotomy attempts.
Of the nine requesting testing, only eight received testing due to failed phlebotomy attempts.
Twenty women and 10 men completed the questionnaire. Women rated the van and a doctor's office as equally acceptable locations to self-collect samples (urine: means 1.58 and 1.32 respectively, P = 0.16; vaginal: means 1.45 and 1.30 respectively, P = 0.41). In contrast, men rated the van as less acceptable than a doctor's office for self-collection of urine but not penile samples (urine: means 2.38 and 1.63 respectively, P = 0.03; penile: means 2.33 and 1.78 respectively, P = 0.06). Men and women reported that STI testing in a van was more acceptable (lower mean score) with shorter turnaround times: (4–14 days, mean score = 3.1; 1–3 days, mean score = 2.7; more than 2 h but on the same day, mean score = 2.1; 1–2 h mean score = 1.8; <1 h, mean score = 1.5; P < 0.05 for each turnaround time compared with “more than 2 h but on the same day”.
Discussion
By providing the combination of POC and near-patient testing with STI screening in a venue accessible to the general public, we demonstrated that community event attendees sought testing and found self-collecting samples to be acceptable. We are unaware of other reports on the use of POC trichomoniasis or near-patient CT/NG testing in a mobile health care setting. In the present study, POC and near-patient tests were the preferred method of STI testing. Additionally, infections were detected in those tested in this nontraditional setting for STI services.
Conclusion
Future STI screening initiatives should consider using mobile settings to improve accessibility for populations with a high prevalence of infection and incorporate POC and near-patient testing to provide timely results and treatment.
Acknowledgements
This data was presented in part in June 2014 as two poster presentations for the Centers for Disease Control and Prevention (CDC) 2014 STD Prevention Conference. We would like to thank Jill S. Huppert, MD, MPH, for her contributions to this project including conception and design, acquisition of data, and administrative, technical and material support. This project was supported by grant number 2 U54 EB007958 (Gaydos) from the NIH/NIBIB and NIAID NIH U-01 AI 068613 (Gaydos).
Footnotes
Conflicts of interest
Dr Lea E. Widdice reports that she has received kits and reagents from Cepheid®. However, the company had no access to the data or to the manuscript under review. Dr Charlotte Gaydos has received research support from Cepheid. No other conflicts of interest are reported for the other authors.
References
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