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 US, with follow-up sites in Mexico, and Guatemala. The goal is to see if the research patch is better at reducing the symptoms of Travelers’ Diarrhea than a patch not containing the research material, called a placebo.
Study subjects will have a 50:50 chance, like flipping a coin, to get the research patch or the placebo patch. The research patch is placed on the upper arm for 6 hours, once at the start of the study and again 14 days later. After waiting at least 7 days from the last patch application, participants may depart from the US for their destination-country.
Participants must check-in at a destination-country study clinic within 1-2 days of arrival in the destination-country. Following check-in, they may continue vacation travel until a follow-up clinic visit about one week later. After the follow-up visit, and depending on their travel plans, travelers will take part in the surveillance or observation period for at least 7 and up to 17 days while in the destination-country.
If we find this research study might be a good match for you, you will be asked to visit a study doctor for the first of your two US clinic visits and will be able to get any additional study details you need at that time.
Are the patches and study-related procedures free?
Yes. Should you qualify and enroll, you will receive the patches and study related procedures at no charge.
If we find this research study might be a good match for you, you will be asked to visit a study doctor for the first of your two US clinic visits and you will be able to get any additional details about study procedures at that time.
Will I get paid to participate in the research study?
If we determine that this research study might be a good match for you, you may join a pre-paid tour program or may make your own tour plans with your own travel and hotel reservations. Details on pre-paid or reimbursed travel and specific study related expenses will be provided by the research study travel
coordinator and may be up to $1,500 depending on the completion of study visits and procedures.
What is considered a developing country?
Some examples of developing countries include
- Central America (except Costa Rica)
- Mexico
- Caribbean Islands (except Puerto Rico)
- South America (excluding Chile, Uraguay, Argentina)
- Africa (All)
- Asia (All except Hong Kong, Singapore, and Bangkok area of Thailand)
- Middle East (All except Israel)
What are the components of the patch?
Providing a listing of all of the “ingredients” of the research patch is beyond the scope of this website, but we can say that the circular patch is made up of an adhesive, similar to that in a Band-aid, and the research material is located at the center of the patch in an area about the size of a US 25 cent coin, a “quarter.” The placebo patch looks like the research patch but does not contain the research material.
Who is paying for this research study?
Participating study clinicians are paid by the sponsor pharmaceutical company to perform this research study. If we determine that this research study might be a good match for you, your information will be sent to a participating doctor near you who can give you additional details about the sponsor.
What is the research patch?
The research patch is a circular piece of adhesive, like Band-aid adhesive, that contains material from the bacterium that commonly causes travelers diarrhea. The patch has been tested in more than 25 clinical research studies.
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 San Miguel de Allende, Guadalajara, Mexico City, Oaxaca, and Cuernavaca. The Guatemalan study clinics are in Antigua, Quetzaltenango, Guatemala City, and Panajachel.
How long will my research study participation take?
In addition to the vaccination period of at least 3 weeks in the US, the study-related travel in your destination-country may last from at least 7 and up to 17
days. A final questionnaire will be completed after your return to the US and about 6-months after your first vaccination.
What is Travelers’ Diarrhea?
Travelers’ Diarrhea 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’ diarrhea.
Travelers’ Diarrhea 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, Travelers’ Diarrhea 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 determine that this research study might be a good match for you, 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 determine that this research study might be a good match for you, you will be asked to visit 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?
Please be advised that if you contact us 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 your information private and secure. The information you provide will only be shared with those involved in the clinical program, if it is determined that you may be eligible to participate.
Your information will not be sold to outside companies, nor will it be stored or collected without your direct consent.
When will medical screening begin for the TREK research study?
The TREK research study will begin screening volunteers around January 2009. We will continue to provide you with updates on the study over the next few months until you travel to Mexico or Guatemala.
Will I be given insurance to cover my travel in this research study?
Intercell is providing travel insurance to cover other aspects of risk, including other illness associated with the travel/presence in Central America. An insurance assistance card will also be provided to each subject. |
