J.11 - Example Recruitment Plan Template.pdf

Attachment J.11 – - Solicitation # 75D301-20-R-67869

S37.Part D Recruitment, Screening, and Retention

26feb2018

TBTC Study 37/ TBESC Part D Site Implementation Plan: Recruitment, Screening, and Retention

INSTRUCTIONS

Please read section #10 on the ‘Study Start-Up and Implementation Requirements:

Submission Process’

Please answer the following questions for your site. Indicate if and when procedures will differ between recruitment locations, and provide detailed descriptions of any location-specific differences. Use the following file name to save the document (please update site number, name and date):

TBTC Sites: S37.Part D Recruitment Plan TBTC Site ## Site Name

TBESC Sites: S37.Part D Recruitment Plan TBESC Site ## Site Name

TBTC/TBESC Sites: S37.Part D Recruitment Plan TBTC.TBESC Site ## Site Name

MRC Sites: S37.Part D Recruitment Plan MRC Site ## Site Name

Submit to tbtcstudy37@cdc.gov with the following EMAIL SUBJECT:

TBTC Sites: Recruitment, Screening and Retention Plan TBTC Site ## Site Name

TBESC Sites: Recruitment, Screening and Retention Plan TBESC Site # Site Name

TBTC/TBESC Sites: Recruitment, Screening and Retention Plan TBTC/TBESC Site ##

Site Name

MRC Sites: Recruitment, Screening, and Retention Plan MRC Site # Site Name

Obtain email approval from the TBTC/TBESC Data and Coordinating Center

1 SITE INFORMATION

Site Number

Site Name

Site Address

Recruitment Location(s) mailto:tbtcstudy37@cdc.gov

26feb2018

2 RECRUITMENT

a. How will buy-in be developed and orientation be done among site staff who will participate in Study 37/Part D?

b. How does the site staff identify potential participants [e.g., what criteria will be used to decide who to approach; how will study staff describe the study; what pre-enrollment activities will be conducted (such as review of clinic appointment lists the day before, etc.)]?

c. Name the top 3-5 countries from which your site anticipates recruiting potential participants under “recent (within 2 years prior to enrollment) immigration to the US or

UK” eligibility criteria categories

d. How will participants learn about Study 37/ PART D?

26feb2018

e. Does the site plan to enroll participants who are <18 years old? If not, why?

3 RECRUITMENT POPULATION

Describe the populations that will be recruited at each study location

Name of location(s) where recruitment will occur

Location of setting in relation to main study site

Enrollment Estimates (n)

Monthly Total

Household and other close contacts (> 4 hours of exposure a week) within 2 years prior to enrollment, of persons with culture-confirmed infectious TB

Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment

HIV infection

≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for active or latent TB

Recent (within 2 years prior to enrollment) immigration to the US or UK, with an abnormal chest X-ray obtained in the U.S.

Recent (within 2 years prior to enrollment) immigration to the US or UK from a country with estimated incidence rate of TB > 150 per 100K

An increased risk of TB due to medical conditions

4 PRIVACY

For each recruitment location describe how privacy and confidentiality of study participants will be maintained, including the following:

26feb2018

a. During encounters with participants done in person, via telephone, via video

b. Storage of study-related documents, including participants’ records

c. Communicating information to other staff members at a different recruitment location

d. Sharing information with outside institutions (labs, data center, etc.)

e. Data entry

26feb2018

5 INFORMED CONSENT

a. Please describe the site-specific informed consent process.

b. How does the site ensure that the participant understands the informed consent?

c. Please describe how completed informed consent forms are reviewed for their completeness at the site.

d. Does the site use the short form? If so, please describe the details of how informed consent is administered with a short form (including the languages used).

26feb2018

6 SCREENING

a. Please describe the site’s overall screening process.

b. Are potential participants screened for other studies besides Study 37/ Part D? If yes, please describe the types of other studies and how informed consent is handled when screening for multiple studies (for example, is there a 2-part consent process where all persons screened are generally consented and then again for study-specific consent)?

c. Please describe how site staff will provide general education about contraceptive methods to women of childbearing potential. If condoms are available free of charge at the health department or other local facility, please note it in your response.

7 COMPENSATION AND INCENTIVES

a. Do participants receive any forms of compensation/reimbursements (e.g., travel expenses (bus tickets, road/bridge tolls, gas mileage, etc.))? If yes, please describe.

26feb2018

b. Do participants receive any forms of incentives (e.g. cash/gift cards for visits/completion of treatment or follow-up, etc.). If yes, please describe in details (include interval of how often they receive incentives, amounts, any conditions that have to be met).

c. How are the disbursements documented?

8 RETENTION, ONGOING STUDY ACTIVITIES, AND LTBI TREATMENT

Provide a detailed explanation of how the following activities will be performed at each study recruitment location:

a. Provide foreign language interpretation services

b. Schedule phone evaluations, treatment and follow-up appointments

c. Adhere to the participants’ study schedule

26feb2018

d. Conduct follow-up interviews at 6, 9, 12, 18 & 24 months.

e. What types of communication will be used to maintain contact with participants?

f. What if a participant seeks care outside of the trial site? How will the participant be educated to inform an outside provider of his or her participation in the clinical trial? (A participant wallet card with study information is available from the TBTC/TBESC DCC.)

g. How will the site obtain and evaluate medical records of participants who develop TB disease (for completing the Suspected Development of TB Form).

26feb2018

h. How will the site maintain contact and conduct evaluations for TB, if a participant moves away during follow-up?

i. Please describe how state TB data will be made available to your site for registry matching (e.g., previous agreements with the TB program, shared database, etc.).

9 RECRUITMENT, SCREENING, AND ENROLLMENT FLOW DIAGRAM/SCHEMATIC

Please provide a detailed step-by-step flow diagram of the recruitment, screening, and enrollment process at the site, with associated timelines. Please include all steps from where potential participants are identified through enrollment of the participant. Be sure to include details such as the following:

• Where potential participants are identified

• Timing of informed consent (please remember that study-specific tests CANNOT occur before informed consent)

• What happens when a participant does not meet eligibility criteria (e.g. where/if will they be referred for treatment elsewhere)

• Timing and flow of evaluations for eligibility

• Timing and flow of laboratory involvement

• Names of labs, clinics, and other study-related locations

26feb2018

• Complete non-enrollment form

• What happens to patient?

PASS

PASS

PASS

Conduct Informed

Consent with Participant

Example of Recruitment, Screening, and Enrollment Process Template (Note: The following is an example from an ongoing trial of treatment of active TB. Please develop flow diagram for your site-specific process for this LTBI trial.)

New Symptomatic Respiratory

Patient in the Health Center

Pre-Screening Process to evaluate the possible candidates with a quick interview

Screening visit

Screening Sputum sample for

Smear, Xpert, MTBDRplus and Cultures

RIF Sensitive [Smear (+)] OR [Xpert (+) Medium/High and RIF-S]

Will your site use additional assays to determine resistance? _____ If yes, please include tests: ____________

If patient has drug-susceptible TB, meets all other eligibility creiteria, and there is sufficient drug supply

Baseline Visit

Day(s):

Day(s):

Day(s):

Day(s):

____ Sputum sample for

Smear, Cultures and

Phenotypic DST testing

FAIL

FAIL

FAIL

Randomized

26feb2018

Additional Site Specific Information

10 APPROVALS

TBTC/TBESC Site Specific Recruitment, Screening, and Retention Plan for Study 37/Part D Approved by

Principal Investigator

Signature__________________________________________________Date ____________

TBTC/TBESC Site Specific Recruitment, Screening, and Retention Plan for Study 37/Part D Approved by

Study Coordinator

Signature__________________________________________________Date ____________