Frequently Asked Questions

Can you tell me more about the study/what are the study goals or objectives?

This clinical research study is being conducted at multiple sites in the UK and Germany, with follow-up sites in Mexico and Guatemala.

The goal is to see if the patch containing the research material, called the investigational patch, is better at reducing the symptoms of Travelers' Diarrhea than a patch not containing the research material, called the placebo patch.

Fifty-percent of all participating volunteers will receive the investigational patch, and fifty-percent will receive the placebo patch. The placebo patch looks like the investigational patch, but does not contain the medical research material. The investigational patch will be placed on the upper arm for six hours, once at the start of the study, at your first study visit and again 14 days later, at your second study visit. After waiting at least seven days from the last patch application, participants may depart from their country of origin in the UK or Germany for their destination country.

Participants are required to check-in at their destination-country's study clinic within 1-2 days of arrival. Following check-in, they may continue vacation travel, staying within 3 hours travel distance to a study site until a follow-up clinic visit seven days after the check-in visit. After the destination-country check-in visit, and depending on their travel plans, travelers will be taking part in the surveillance or observation period for at least seven and up to 17 days.

Are the patches and study-related procedures free?

Yes. Should you qualify and enroll in the study, you will receive the investigational patch and study related procedures at no charge.

If we find that you may be a good candidate for this research study, you will be asked to visit a study doctor for the first of your two clinic visits in your country of origin. Additional details about study procedures will be provided to you at this time.

Will I get paid to participate in the research study?

After we receive confirmation that you have qualified at your first visit, and you have been contacted by our travel agent to confirm your travel plans, you will be sent a debit/cash card that will be reloaded as you complete study requirements.

There are two options for a reimbursement plan. The first option is called a Fixed Itinerary Compensation Plan (available to UK residents only). You will receive scheduled, automatic payments to your debit card as you complete study requirements. If all visits are completed you will receive £139. In addition you will receive compensation for your airfare and accommodations up to a maximum of £1300 pounds.

Upon arrival in Mexico, transportation from the airport and to your first clinic visit in country will be provided on behalf of the study. In Guatemala transportation will also be provided from the airport to your first clinic visit in Guatemala City or Antigua. Any additional travel will be the subjects' responsibility.

Once you qualify for this study at the clinic site our travel specialists may arrange your travel plans to ensure your participation in the study.

The second option is called the Independent Traveler Compensation plan.

This plan requires you to pay for your air and hotel accommodations prior to traveling and you will be reimbursed throughout the study.

You must also provide proof of passport, flight receipt and hotel itinerary and complete all vaccination procedures.

If all visits are completed you will receive £1,439 or 1,584 Euros in compensation.

Once you qualify for this study at the clinic site our travel specialists may arrange your travel plans to ensure your participation in the study.

As you complete a visit, you will be reimbursed on a debit/gift card. Each time a visit is completed, money will be placed on the card as outlined in the informed consent form. This card can be used in your country of origin or in your destination country. The cards can be used anywhere Mastercard is accepted.

These plans will be explained in further detail by a call center representative.

Can you provide me with further details about study participation?

You will have 2 clinic visits prior to traveling. At your first clinic visit, the study staff will review the details of the study, answer any questions and review your responsibilities for participation as outlined in a document called the Informed Consent Form.

If you qualify and agree to participate, you can expect to:

have a small amount of blood drawn
take a pregnancy test if female of child bearing potential
have a brief physical inspection
receive a study diary that will need to be updated daily
receive your first vaccination patch applied to your upper arm to be worn for six hours
and will be scheduled for your second vaccination appointment to occur two weeks later

Following this first visit, travel must take place within 21-44 days

You will be contacted by a TREK travel consultant to review and/or book your travel accommodations and schedule your first visit in Mexico or Guatemala. Please remember you must remain in country for at least 7 days but are welcome to stay longer.

Your second study visit will take place 14 days after your first study visit. You will receive your second vaccination patch on the other arm, have a brief physical inspection and review your diary.

72 hours following both your first and second vaccination clinic visits, you will receive a call from a study clinician

Following this second visit, travel must take place within 7-30 days

Upon arrival in your destination city you will need to attend a clinic visit within 24 hours for some additional lab work and to review your diary

At this visit you will be given a backpack with travel goodies and stool collection kits that you should keep with you in case of diarrheal episodes. The backpack with travel goodies are yours to keep as our appreciation for participating in this study.

Your next appointment will be scheduled at this visit. If transportation is needed there is an in country transportation company who you should contact to coordinate your travel. Please be prepared to tell them the date and time of this visit

Your second study in-country visit at one of the study clinics occurs seven days after your first in-country visit

One more visit will be scheduled 17 days after your in-country arrival date. This visit can be completed in Mexico or Guatemala or back in your country of origin

Participants must stay within 3 hours traveling distance to one of our medical study sites while they are in-country.

You will be contacted to complete a final clinic visit six months after your day 17 visit in your originating country.

How will my travel be booked?

A TREK study travel consultant will contact you to review and/or book your travel, accommodations and transportation needs, or you may make your own travel arrangements.

How long do I have to stay in Mexico or Guatemala?

You must remain in-country for at least 7 days, but are free to stay longer if you should choose to do so. Please note that the Day 180 Visit (6 month follow up) must occur at the site in the Origination Country.

How many study visits are there and what do they include?

There are a total of up to four study visits and two study phone calls in your country of origin and up to three study visits to be completed in your destination country. Your first two appointments in your country of origin are vaccination appointments. Your second study visit will take place 14 days following your first study visit. This visit will include the application of the second vaccination patch, review of your study diary, and another brief physical inspection.

Travel to Mexico or Guatemala must take place 21-44 days after your first vaccination visit and 7-30 days after your second vaccination visit. You must attend a study visit at one of the designated medical sites in Mexico or Guatemala within 24 hours after arrival. At this visit you will need to bring your study diary with you for submission, have blood drawn and another brief physical inspection, receive a second diary for the remainder of your study participation, and receive stool collection kits to utilize in the event of any diarrheal episodes.

A second study visit is required in your destination country seven days after your first visit, and will be scheduled at your first visit. You will also need to attend a final study visit 17 days after your first in-country visit. This can happen in your country of origin or in Mexico or Guatemala. You will be contacted to complete a final clinic visit in your country of origin six months after your day 17 visit.

What is considered a developing country?

A developing country is one having an economy that is largely farm-products based and having a low per-person average annual income. Some examples of developing countries include:

Mexico
Guatemala
Most countries in Africa

What is the research patch? What is the research patch made of?

The investigational skin patch is an adhesive, similar to a circular Band-aid or bandage and about 50mm in size. The medical research material is located at the patch center in an area about 25mm. The placebo patch looks like the investigational patch, but does not contain the medical research material. The patch has been tested in more than 25 clinical research studies.

Who is paying for this research study?

Participating study clinicians are paid by the sponsor to perform this research study.

What hotel accommodations are available?

Hotel accommodations include exclusive lodging located near local attractions and points of interest with upgraded amenities. Once you qualify for this study at the clinic site, our travel specialists may arrange your travel plans to ensure your participation in the study.

Where are some of the places I might go in Mexico or Guatemala during this research study?

Participants should travel no further than 3 hours away by surface transportation such as car, bus or taxi from the nearest study clinic. The Mexican clinics are in Mexico City, Guadalajara, Oaxaca, Cuernavaca, and San Miguel de Allende. The Guatemalan study clinics are in Antigua, Guatemala City, Quetzaltenango, and Panajachel.

How long will my research study participation take?

Approximately 6.5 months is needed to complete the entire study. The majority of the study is completed within the first 40 days, with a final clinic visit occurring 6 months after your Day 17 visit.

What is Travellers’ Diarrhoea?

Travellers’ Diarrhoea is a disorder affecting up to 50% of people who travel throughout the developing world. It is typically caused by ingestion of contaminated food or drink. Dehydration is one of the most serious and potentially life-threatening consequences of severe or prolonged travelers’ diarrhoea.

Travellers’ Diarrhoea is commonly recognized by symptoms such as:

increased frequency or urgency of passing soft or watery stools;
stomach or intestinal cramping;
and nausea with or without vomiting.

Untreated, Travellers’ Diarrhoea usually lasts 3-5 days, but can last longer and may require treatment by medically trained personnel.

What are the risks of being in this research study?

If we find that you may be a good candidate for this research study the possible risks and benefits from participation will be explained in complete detail by site personnel during your first clinic visit.

When will I know if I’m eligible?

All final decisions confirming your eligibility will be made at the study site in your area. If we find that you may be a good candidate for this research study, you will be asked to go to a participating clinic for your first visit. A final screening will be completed during your first clinic visit.

How is my personal information kept confidential? What is your Privacy Policy?

If you contact us by telephone or through this website, you may be asked to provide personal information including name, age, gender, geographic location, phone number and email address.

We take all reasonable precautions to keep any personal information you provide private and secure. The information you provide will be transferred to the central study administration in the United States, Inclinix Incorporated, and will be accessible only by other involved study personnel at your vaccination clinic in the UK or Germany, the clinic at your travel destination of choice (Mexico or Guatemala) and the study administration in Europe-A+ Science.

Your information will not be sold to outside companies, nor will it be stored or collected without your direct consent. For a detailed Privacy Policy Statement of the central study administration in the United States click the "Privacy Policy" button on the website www.inclinix.com. The Privacy Policy Overview on this website also provides privacy policy related information for the study administration in Europe: A+ Science.

When will medical screening begin for the TREK research study?

The TREK research study began screening volunteers in October 2009. After screening, we will provide you with information to keep you updated prior to your travel to Mexico or Guatemala.

What if study enrollment is delayed or stopped before I can get the vaccine patch?

Joining this study is your choice. You may refuse to be in the study or stop participating at any time without loss of benefits to which you are otherwise entitled. While the study doctor or sponsor may stop your participation at any time for any reason without your consent, every reasonable effort will be made to notify you as soon as possible of any changes in study enrollment activities such as enrollment delay or stoppage due to study supplies availability, curtailment of enrollment, etc.

Will I have to eat or drink the local food or water to be in the study?

This study does not require you to eat or drink food or water that you do not choose for yourself. Your home-country clinic, where the research vaccine patch is applied, will give participant traveller's information and instructions on how to avoid Travellers' Diarrhoea.

Will I be given insurance to cover my travel in this research study?

The sponsor of this trial is providing travel insurance to cover other aspects of risk, including other illness associated with the travel/ presence in Latin America. An insurance assistance card will also be provided to each subject. The insurance provided is for health related coverage. The insurance does not cover items such as lost luggage or canceled flights. You are free to obtain this type of travel insurance, but you will be responsible for payment.

Will I need a credit card when I travel?

It is best to have a credit card instead of carrying large amounts of cash. In addition, a credit card will be needed if you present to a hospital with a medical emergency.

How many vaccinations will I receive?

You will receive a total of 2 vaccinations. You will receive the first vaccination on one arm, and 14 days later receive the second vaccination.

What is the timing for my vaccinations and my travel?

You will receive 2 vaccinations, 14 days apart. Then you must travel between 7-30 days after you received your second vaccination. It is very important to maintain the timing of your vaccinations in order to keep your preferred travel dates. If you must reschedule or cancel an appointment, please notify the TREK study team or the clinic where you were assigned. If you are unable to reschedule the appointment in a very specific time frame, there is a chance that either your travel dates will need to be changed or you will no longer qualify to travel. Please keep this in mind when selecting your travel dates, as well as making your appointments.

What is my risk of contracting the Swine Flu?

Swine flu (H1N1) is a new influenza virus that has never been seen in humans. The virus has now been reported worldwide. The majority of people who contract the H1N1 virus experience the milder form and recover without any antiviral treatment or medical care. A minority of individuals develop illness that can be severe, and in rare cases, fatal, even with medical intervention. Many of the individuals who developed the severe illness had underlying health conditions or weak immune systems. Pregnant women are also at an increased risk; therefore, you should not become pregnant while participating in this study.

The World Health Organization (WHO) states that travelers can protect themselves and others by following simple prevention practices that apply while traveling and in daily life:

Clean hands thoroughly with soap and water, or cleanse hands with an alcohol-based hand rub on a regular basis
Avoid touching your mouth and nose
Avoid close contact with people who might be ill

During the travel phase of this study, should you feel like you are becoming ill, or have flu-like symptoms, contact your clinic in your destination country at the first sign of symptoms (within 24-48 hours). Symptoms of H1N1 influenza include fever, cough, headache, muscle and joint pain, sore throat, runny nose, and sometimes vomiting and diarrhea. You should contact your doctor once you return to your country of origin if you still feel ill.

Should the doctor in your destination country feel that you need treatment for H1N1, you may be able to receive anti-viral medication from the clinic. Any additional treatment that you may require will be covered by the travel insurance provided to you.

For relevant travel restriction information, please consult your national health authority and/or the World Health Organization (WHO).