Yaws II Survey Form for Health Personnel  
INFORMED CONSENT for study participation of Health Personnel

You are invited to participate in this study entitled: NATIONWIDE YAWS ACTIVE SURVEILLANCE AND CASE DETECTION
 IN SELECTED AREAS OF LUZON AND VISAYAS REGIONS IN THE PHILIPPINES

This study is commissioned by the Department of Health- Health Policy Development and Planning Bureau and and the Philippine Council for Health Research Development.  This part of the study aims to assess the presence of possible yaws cases in areas of the Philippines that had no reported cases of yaws since 1961.

Please answer this online form WHETHER OR NOT you have encountered any yaws case in the past.
These are the 3 steps you will take as a participant in this survey:

1. Prior to answering this survey form, please study the Yaws information material I emailed you or linked to this form.  
2. Accomplish this Google Form and submit it within 1 week of receiving the form.
3. Refer possible or confirmed yaws cases between the time you answer the survey form until the end of May 2020. Accomplish the Yaws Case Record Form that was emailed to you and send a teledermatology referral to me by email.

I would greatly appreciate your participation in this survey of a forgotten and Neglected Tropical Disease in the Philippines.  I will be following up your response within the next two weeks. Thank you!

Belen L Dofitas, MD FPDS
Principal Investigator
0917-6294329, yawsstudy@gmail.com

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Your Name *
                          Consent to participate in the study                                                          Background
Yaws is one of the WHO Neglected Tropical Diseases.  It is a chronic, contagious, nonvenereal, treponemal infection that manifests mainly in human skin as verrucous, raspberry-like nodules or plaques with moist, yellowish surfaces or may be ulcerated. Yaws mainly occurs in children younger than 15 years. Infection with Treponema pertenue, a subspecies of Treponema pallidum, causes the disease, which occurs primarily in warm, humid, tropical areas and among poor rural populations.  Serologic markers for syphilis are present among yaws cases, causing stigmatization and loss of opportunities for overseas jobs.  

Yaws has not been officially reported in the Philippines since the eradication program ended in the early ‘60s. However, community skin surveys in 1999 and serologic surveys in 2012 detected active and probable yaws cases especially among children in Maguindanao and Cotabato provinces. In 2017, active yaws cases were confirmed in Liguasan Marsh area of Mindanao and at least 5 municipalities were endemic.These surveys raise the possibility that yaws may also be present in other areas of the Philippines, either in active or latent forms, but these may have remained unrecognized or unreported. Further case detection and active surveillance of yaws are therefore necessary in our country.
Study Procedure
1.  You will be asked to study the accompanying information material about yaws and how to report and document suspected cases.

2.  You will be asked to accomplish an Online Questionnaire about your knowledge, opinions, or experiences with yaws cases that you may have encountered or documented in your catchment area.  This study is also for those who have never encountered yaws cases.

3.  You will be requested to answer and submit the questionnaire within one week from receiving it.  

4.  Active surveillance for yaws:  If you encounter a yaws suspect at anytime during the study period, you will be requested to accomplish and submit the Online Referral Form to the Investigators.  The referral should have accompanying clear photographs of the skin lesions. You will have to secure written informed consent for photographic documentation from patients or their guardians.

5. Laboratory tests:  Should you encounter yaws suspects during this 10-month study period, you will be asked to do the following tests to confirm the cases:

5.1 Serologic tests:  have non-treponemal and treponemal serologic tests performed (i.e. either SD Bioline, VDRL, RPR, TPHA, TPPA) if available in your health facility. Alternatively, I will send you serologic test kits via courier.  You will be asked to report the results of the serologic test/s to the Investigators.

5.2  Skin biopsy: You will be asked to have a skin biopsy done on a suspected yaws skin lesion at your health facility if this is feasible.  The skin biopsy specimens will be sent by courier to Dr. Belen Dofitas of the Section of Dermatology, Philippine General Hospital, Padre Faura St., Ermita, Manila.

6.  Key informant interview: You may be invited by the investigators to participate in further online or personal interviews regarding your experiences with yaws.

7.  You may also contact the investigators if you are willing to be interviewed further regarding your experiences with yaws.

Risks and Benefits
Benefits of participating in this study:  Your participation in this study will be of great assistance in confirming the presence or absence of yaws in the Philippines and in guiding future efforts of the Department of Health in addressing this neglected tropical disease.

Risks of participating in this study:  You will need to spend around 10 minutes to accomplish the questionnaire. You may spend 15 minutes to perform a skin biopsy and/or  blood extraction for the serologic test on suspected yaws patients.
Consent
Your participation in the study is voluntary and you may refuse participation anytime during the course of the study. You may refuse to answer any item in the questionnaire.  The information you share with the investigators will remain confidential and will be be used solely for purposes of the study and published reports. You will be duly acknowledged for photographs that may be used for the scientific report, publication, and dissemination of this study.  Questionnaires will be numerically coded. Respondent identifiers (i.e. your name) will not be included in the questionnaire or database. Questionnaires and data will be secured by the investigators (i.e. locked drawer or cabinet, password protected electronic data).

If you have any questions regarding this study, please contact Dr. Belen Lardizabal-Dofitas at 09176294329 or email yawsstudy@gmail.com.

For questions on patient’s rights and grievances, you may contact The  UP Manila Ethics Review Board which has approved this study, and may be reached through  the following contact information regarding rights of study participants, including grievances and complaints:
Ethics Review Committee:  UP Manila Research Ethics Board
Contact Person:  Jacinto Blas Mantaring,  
Contact number: +632 5264346
Email address: upmreb@post.edu.ph

Thank you for your participation!
Answering this questionnaire implies consent to participate. Proceed? *
Please confirm that you have studied the yaws information material provided by email. 1. Yaws Fact Sheet https://drive.google.com/open?id=1SrjpfKgyioz0EQ2ht_nee9lpZDSJzsnM 2. Yaws Recognition Booklet for Communities https://drive.google.com/open?id=1eJJ19iFkJ4zKX98e-iJ1ejdG1MiLfIbV 3. Yaws Clinical Photos Filipinos https://drive.google.com/open?id=1HnBnpn_eeLhX3IuL6_VA08mtpwzItyiA Once you have studied the yaws information material, you will be able to proceed to the survey questions. *
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