Supporting Statement B_1_4_17 CLEAN

Canine Leptospirosis Surveillance in Puerto Rico

Request for OMB Approval of an Existing Information Collection without an OMB Control Number

January 4, 2017

Supporting Statement B

Contact:

Lee Samuel

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E.

Atlanta, Georgia 30333

Phone: (404) 718-1616

Fax: (404) 639-3039

Email: [email protected]

TABLE OF CONTENTS

1. Respondent Universe and Sampling Methods 3

2. Procedures for the Collection of Information 4

3. Methods to Maximize Response Rates and Deal with Non-response 5

4. Test of Procedures or Methods to be Undertaken 6

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 6

Canine Leptospirosis Surveillance in Puerto Rico

Request for OMB Approval of Data Collection Instruments

PART B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

1. Respondent Universe and Sampling Methods

The respondent universe will consist of veterinarians and their support staff in participating clinics or shelters (sites) in Puerto Rico, and owners of enrolled dogs seen at a participating site. In consultation with the Puerto Rico Department of Health (PRDH), every effort was made to select and invite clinics and shelters that would give a good geographic representation of the island, and to include sites from areas where leptospirosis has been previously reported or areas with a high index of suspicion for leptospirosis. Only shelters with an on-site vet or that are serviced by a vet clinic will be invited to participate. Sites that agree to participate will be enrolled. At least 20 and no more than 26 sites will be enrolled in the study.

Dogs meeting the criteria for a suspect case based on the study case definition are eligible for enrollment at participating sites. In clinics, consent from the dog owner is required prior to enrollment. In shelters, consent is not needed as no owner exists. A sample size of at least 385 dogs will be enrolled in the study. There is little known regarding the prevalence of leptospirosis in dogs in Puerto Rico, and therefore this sample size was determined based on a population estimate of 150,000-300,000 dogs by the Humane Society of Puerto Rico (unpublished data), a 95% confidence level with a 5% margin of error, and a prevalence of 50% which is the estimated prevalence of leptospirosis in dogs giving the largest sample size.

Based on anecdotal information from veterinarians in Puerto Rico, we expect an approximate of 2 dogs tested per site per month, one of which may be positive upon confirmatory testing. Assuming those numbers are correct we can expect up to 240 positives (1 positive x 12 months x 20 sites) and 240 negatives. Comparing the proportion of risk factors among leptospirosis positive and negative dogs with those expected numbers will allow us to detect differences as small as 10% with at least 80% power. Any analysis of risk factors will consider the power to detect differences and will be reported in a final report.

Leptospirosis is endemic in Puerto Rico, however, there is very limited data on canine leptospirosis in the island. In 1980, Farrington and Sulzer¹ did a serosurvey of antibodies to Leptospira in 116 stray dogs at three shelters in the island. They found seropositivity in 63% of the dogs. In 1998, an unpublished serosurvey of Leptospira antibodies in stray and companion dogs found seropositivity in a third of dogs sampled.² Since then, no study has been done on leptospirosis in dogs.

The study associated with the collection of information addressed in this request aims to establish the first active surveillance for canine leptospirosis in Puerto Rico to determine the incidence and distribution of leptospirosis in dogs, assess risk factors for infection, characterize circulating Leptospira serovars and species, assess applicability of vaccines currently in use based on serovar determination, and assess potential rodent, livestock, and wildlife reservoirs based on infecting serovars found in dogs.

Collaboration with PRDH will help ensure that data collection activities are conducted in a culturally and linguistically appropriate manner, and enhance participation from the veterinary clinics and animal shelters in Puerto Rico.

Population of dogs in Puerto Rico	Confidence level	Margin of error	Power	Estimated prevalence of canine leptospirosis	Sample Size	Number of sites to enroll
150,000 – 300,000	95%	5%	80%	50%	385	20-26

2. Procedures for the Collection of Information

Three information collection tools – a one-time site questionnaire, a log sheet of enrolled dogs per site, and a case questionnaire for each enrolled dog – will be used in the study. Except for the log sheet which has the option of an electronic version, all information collection will be conducted using paper forms and provided in Spanish.

Site Information Collection

Each enrolled site is asked to complete a one-time site enrollment questionnaire. This paper form collects basic information about the site such as site capacity and available resources, an estimate number of dogs seen by the site, an estimate of suspect cases of leptospirosis, the method and communities from which dogs are acquired (shelters only), and dog vaccination practices. Examples of questions include whether the site has a computer and internet access; whether they vaccinate dogs for leptospirosis and if so, what Leptospira vaccine is used; how many dogs per week or month are being seen and how many of these have febrile illness of unknown cause; how many dogs are diagnosed or suspected to have leptospirosis; and specifically for shelters, how many dogs are acquired each week, what methods are used to acquire these dogs (i.e. picked up in communities or surrendered by owners), and which communities they come from. The completed site questionnaire is submitted to study coordinators by email or in-person during site training.

Case Information Collection

Participating sites will enroll dogs that meet the criteria for a suspect case based on the study case definition. In clinics, consent from the dog owner is required prior to enrollment.In shelters, consent is not needed as there is no owner. Consent is obtained through the Owner Consent Form. The veterinarian or a veterinary technical staff will explain to the owner the nature of the study and will ask the owner to sign a paper consent form prior to enrolling the dog in the study. After consent is obtained, information collection, specimen collection and testing is pursued.

Information about the enrolled dog is obtained through the Case Questionnaire. This paper form will be completed by the veterinarian or veterinary technical staff by interviewing the dog owner (clinics only), and reviewing administrative and medical records, as necessary. The case questionnaire includes questions about the dog’s signalment, risk factors and exposures, vaccination history, clinical signs and symptoms, laboratory test results for leptospirosis and routine lab work if available (i.e. hematology, urinalysis, chemistry), treatment given, and outcome. Completed forms can be sent to study coordinators by fax or email, or along with specimen shipments to CDC, depending on site preference.

Enrollment and Specimen Collection Tracking

Each site is asked to keep a log of all enrolled dogs using the Study Log Sheet. This form is used to keep track of all enrolled dogs and specimens collected in the study, and also serves as an itemized list of contents when shipping specimens to CDC. All information requested in the log sheet can be obtained from the case questionnaire and is limited to basic information needed to track enrolled dogs and collected specimens such as study ID, site ID, owner’s last name, dog’s name, gender, illness onset date, rapid test results and type of specimens collected. Completed log sheets are sent with the monthly specimen shipments to CDC.

Training of Participating Veterinarians and Veterinary Technical Staff

Participating veterinarians and their staff will be trained on the study protocol during a 1.5-hour training session. The training session will cover the procedures for obtaining consent, collecting data and specimen, and using the leptospirosis rapid test. Materials presented during the training session and additional materials such as a procedure flowchart and copies of data collection forms are compiled in a binder and provided to each site.

Interventions

Owners of dogs that are rapid-test positive for leptospirosis may be given an informational brochure on leptospirosis, and dogs will be treated with antibiotics based on normal veterinary clinic procedures. Overall findings from the canine leptospirosis surveillance study will be used to develop evidence-based, targeted interventions and recommendations for the prevention of canine leptospirosis which can also lead to reduced leptospirosis transmission in humans, help focus human surveillance efforts based on incidence and distribution data, and guide future investigations into leptospirosis in humans and animals in Puerto Rico.

3. Methods to Maximize Response Rates and Deal with Non-response

BSPB and PRDH will make every effort to provide participating sites with the necessary information, tools and technical support to conduct the information collection. BSPB and collaborators at PRDH may conduct periodic site visits or phone calls to get feedback from the sites, identify supplies they may need or will be needing soon, identify issues that may become a barrier to information collection, and generally, reach out to the sites for continued participation in the study. Finally, periodic reports may be prepared for the sites to show study progress with the hope that this can also encourage continued participation and response in the study.

Except for the log sheet which has the option for an electronic version, all information collection tools are in paper form. Veterinarians and their staff may find it easier to complete a paper copy of the data collection forms when abstracting information from administrative and medical records or while interviewing the owner for risk factors and symptoms. All forms are provided in Spanish.

B.4. Test of Procedures or Methods to be Undertaken

Before implementation of information collection tools, feedback from collaborators at PRDH was sought. Collaborators at PRDH have close ties with the local veterinarians and know well the conditions vet clinics and shelters work in Puerto Rico. The length of the instrument and the burden this would pose to veterinarians, the method of data collection that would be easiest for the sites, what and how to train the sites on, and the logistics on data collection and submission to study coordinators that would be most convenient to the sites were discussed. All information collection tools were translated to Spanish. Collaboration with PRDH will help ensure that data collection activities are conducted in a culturally and linguistically appropriate manner, and enhance participation from the veterinary clinics and animal shelters in Puerto Rico.

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

William Bower (404) 639-0376, [email protected]

Ilana J. Schafer (404) 718-4661, [email protected]

Aileen Artus (404) 639-3474, [email protected]

Dana Haberling (404) 639-2144, [email protected]

Kyle Ryff (787) 765-2929 ext. 3556, [email protected]

Brenda Rivera-Garcia (787) 399-9565, [email protected]

Krizia Santos (787) 765-2929 ext. 3556, [email protected]

Other members of the Bacterial Special Pathogens Branch and the Division of Epidemiologic Investigation at the Puerto Rico Department of Health may be involved in the management and analysis of information collected from surveillance activities.  All data collection is conducted by veterinary clinic and animal shelter staff in Puerto Rico as coordinated by the Division of Epidemiologic Investigation at the Puerto Rico Department of Health.

1 Farrington, N. P. and K. R. Sulzer (1982). "Canine leptospirosis in Puerto Rico." Int J Zoonoses 9(1): 45-50.



2 Torres, F.J. et. al. “Canine Leptospirosis in Puerto Rico.” Unpublished study, Tuskegee University College of Veterinary Medicine, Nursing, and Allied Health, 1998.