Clinical trial NCT02029872
Conditions: MRSA
Keywords: MRSA colonization decolonization
Sponsor: Johns Hopkins University
Start date: 2014-01-01; Completion date: 2017-03-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to learn more about an approach to remove Methicillin resistant Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient settings and among their household members and sexual partners.

MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make people very sick. The bacteria have been seen in a high number of persons in the Baltimore area and in hospitals throughout the country. MRSA can be spread from person to person, particularly in homes and among family members and sexual partners.

There are three things the investigators hope to learn from this research study:

First, the investigators want to find a way to prevent MRSA infections in outpatient settings. By asking questions, the investigators want to look at the things that may increase the risk of having this type of bacteria in you and your family members.

Second, the investigators have soaps and oral rinses (Chlorhexidine) and medications (antibiotics; Mupirocin ointment) that have been shown to be effective at removing MRSA. The investigators want to determine if these antibiotics and soaps are best used for everyone in the household or only the individual with known MRSA.

Third, as the investigators, we want to learn more about the bacteria by looking at it on the inside. The investigators will do laboratory tests on samples we collect, to learn how MRSA bacteria grow, reproduce and how it develops to behave differently than other types of MRSA bacteria.

Detailed description:
Methicillin resistant Staphylococcus aureus (MRSA) kills more patients in the United States (U.S.) than Acquired Immunodeficiency Syndrome (AIDS). Further, persons living with Human Immunodeficiency Virus (HIV) experience MRSA infection at significantly higher rates than the general population (12.3/ 1000 person years compared to 1 to 2/1000 person years) and MRSA remains a substantial reason for hospital admission among this patient population. Colonization with Staphylococcus aureus is a major risk factor for infection in persons living with HIV and AIDS (PLWHA) and eradication of MRSA colonization reduces the occurrence of subsequent infection in patients. Household contacts with MRSA colonization increase failure rates of decolonization. The clinical practice guidelines for MRSA management from the Infectious Diseases Society of America (IDSA) recommend providing decolonization to persons with repeated skin and soft tissue infections as well as their household contacts; however, the guidelines report that evidence is limited in support of this recommendation. Additionally, these recommendations do not include sexual partners outside the home and there is mounting evidence of MRSA transmission between sexual partners and sexual networks. Strategies that reduce the spread of MRSA among people living with HIV/AIDS (PLWHA) are vitally needed to reduce this disparity.

To assess colonization prevalence among PLWHA, investigators conducted an epidemiologic evaluation of MRSA among persons within the Johns Hopkins University AIDS Service (JHUAS). The study included 500 subjects (65.8 % male) along with the sexual partners of 35 subjects. The MRSA colonization prevalence was 16.8% among subjects and 37% (17/35) in their sexual partners (unpublished data). These findings demonstrate an exceptional difference in colonization prevalence in PLWHA compared to the US population and supports the need for further research to understand decolonization regimens that evaluate outcomes for individual decolonization only compared to the inclusion household and/or sexual partner interventions. We propose a randomized controlled trial (RCT) among 100 PLWHA (50 per arm) within the JHUAS to evaluate an individual versus household/sexual partner decolonization intervention.

The specific aims of the proposed RCT are:

1. To compare a MRSA decolonization protocol for the colonized individual (index) versus the index plus their household member and/or routine sexual partner(s).

   H0: Index plus household/sexual partner(s) decolonization will be associated with a lower occurrence of MRSA colonization at 6 months after completion of decolonization protocol.
2. To estimate the intervention effect size and develop an intervention fidelity assessment plan to scale the intervention into a larger multi-city R01 application.
3. To determine the molecular characteristics and antimicrobial susceptibilities of both the clinical and colonizing isolates among index patient as well as household members.

Arms: arm 1: Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days. arm 2: Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Interventions: intervention 1: Chlorhexidine gluconate soap intervention 2: Chlorhexidine gluconate oral rinse intervention 3: Mupirocin calcium 2 % ointment
Intervention descriptions: intervention 1: 4% chlorhexidine gluconate (soap) intervention 2: chlorhexidine gluconate oral rinse 0.12% intervention 3: nasal mupirocin calcium 2% ointment

Protocol documents:
Prot_SAP_001.pdf: 
 
 
Protocol with Statistical Plan Cover Page 
 
Title: Stop Community MRSA Colonization Among Patients (SUSTAIN) 
Protocol Date: 6/10/2013 
NCT: NCT02029872 
 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
 
1. Abstract 
Methicillin resistant Staphylococcus aureus (MRSA) kills more patients in the United States (U.S.) than 
Acquired Immunodeficiency Syndrome (AIDS)1.  Further, persons living with Human Immunodeficiency Virus 
(HIV) experience MRSA infection at significantly higher rates than the general population (12.3/ 1000 person 
years compared to 1 to 2/1000 person years)2 and MRSA remains a substantial reason for hospital admission 
among this patient population3.  Colonization with Staphylococcus aureus is a major risk factor for infection in 
persons living with HIV and AIDS (PLWHA)4 and eradication of MRSA colonization reduces the occurrence 
of subsequent infection in patients5. Household contacts with MRSA colonization increase failure rates of 
decolonization6.  The clinical practice guidelines for MRSA management from the Infectious Diseases Society 
of America (IDSA) recommend providing decolonization to persons with repeated skin and soft tissue 
infections as well as their household contacts; however, the guidelines report that evidence is limited in support 
of this recommendation7.  Additionally, these recommendations do not include sexual partners outside the home 
and there is mounting evidence of MRSA transmission between sexual partners and sexual networks8. 
Strategies that reduce the spread of MRSA among people living with HIV/AIDS (PLWHA) are vitally needed9 
to reduce this disparity.   
To assess colonization prevalence among PLWHA, we conducted an epidemiologic evaluation of 
MRSA among persons within the Johns Hopkins University AIDS Service (JHUAS). The study included 500 
subjects (65.8 % male) along with the sexual partners of 35 subjects.  The MRSA colonization prevalence was 
16.8% among subjects and 37% (17/35) in their sexual partners (unpublished data).  These findings demonstrate 
an exceptional difference in colonization prevalence in PLWHA compared to the US population10 and supports 
the need for further research to understand decolonization regimens that evaluate outcomes for individual 
decolonization only compared to the inclusion household and/or sexual partner interventions. We propose a 
randomized controlled trial (RCT) among 100 PLWHA (50 per arm) within the JHUAS to evaluate an 
individual versus household/sexual partner decolonization intervention.  
  
2. Objectives/Aims  
The specific aims of the proposed RCT are:    
 
1. To compare a MRSA decolonization protocol for the colonized individual (index) versus the index plus 
their household member and/or routine sexual partner(s).  
H0: Index plus household/sexual partner(s) decolonization will be associated with a lower 
occurrence of MRSA colonization at 6 months after completion of decolonization protocol.  
2. To estimate the intervention effect size and develop an intervention fidelity assessment plan to scale the 
intervention into a larger multi-city R01 application.   
3. To determine the molecular characteristics and antimicrobial susceptibilities of both the clinical and 
colonizing isolates among index patient as well as household members. 
 
3. Background 
Community-associated methicillin resistant Staphylococcus aureus (CA-MRSA) greatly impacts health 
outcomes among PLWHA.  Outbreaks of CA-MRSA skin and soft tissue infections have occurred in 
metropolitan areas throughout the country including San Fransisco11, Boston12 and Dallas13.  These outbreaks 
have identified key risk differences for CA-MRSA colonization and/or infection among this population 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
including substance abuse 14;15; high risk sexual practices including men who have sex with men and 
heterosexual persons with multiple sexual partners16 as well as a sexual partner with a known skin infection16.  
Risk for MRSA infection also includes lower CD4 counts12;13;16; high viral load12;17; recent hospital admission18; 
β-lactam antibiotics11; routine hands on contact with customers at work16; lack of cotrimoxazole 
prophylaxis13;17; and known MRSA infection in the last 12 months11.  Due to routine interaction with the 
healthcare system, PLWHA who are colonized with MRSA may serve as a reservoir for fueling healthcare 
associated transmission. The identification of high risk community groups harboring MRSA is integral to the 
prevention of transmission within vulnerable populations.   
A recent open-label randomized controlled trial among 183 HIV negative pediatric patients with 
community-onset Staphylococcus aureus skin infections compared decolonizing the entire household versus the 
index child with skin infection alone.   The researchers found the intervention to be successful at prevention of 
skin infection, but it did not lead to greater S. aureus eradication in the colonized children.  The team 
hypothesized this finding to be a result of MRSA contacts outside the home19.   
In this proposed research, we plan to test whether a decolonization intervention has greater impact if 
applied to all members of an index patient’s household and/or sexual partner network as compared to only the 
individual patient. In a prior HIV/MRSA prevalence study, we conducted whole body surveillance for MRSA.  
Through that study, we have identified high and low yield body sites and have reduced the total number of body 
sites that will be evaluated in this study.   We have also modified the risk factor questionnaire previously 
approved in prior studies, to simplify the document and update it with the most recent MRSA and HIV 
literature.   
 
4. Study Procedures  
The applicant proposes a prospective, randomized controlled open-label trial known as SUSTAIN, or 
Stop Community MRSA Colonization among Patients.  The SUSTAIN trial will evaluate MRSA 
decolonization and determine differences in the prevalence of MRSA colonization (main outcome) at 6 months. 
Patients with a known history of MRSA colonization will be recruited from the (JHUAS).  After consent and 
baseline MRSA screening, index subjects (50 per arm), described below, will be randomized to a standardized 
decolonization protocol directed at both the individual and their household and/or sexual partner(s) or a 
decolonization for the individual alone.   Each index (i.e. person living with HIV within the Johns Hopkins 
Moore Clinic) will be approached for enrollment in the study.  Information flyers, study rotating digital kiosk 
and provider referral will be used for recruitment.  We will also search the Johns Hopkins Hospital 
Epidemiology and Infection Control (HEIC) database for known MRSA colonized individuals and contact 
former study participants.    
 
SUSTAIN Standardized Decolonization Regimen (intervention):  
According to the IDSA clinical practice guideline7, the standardized decolonization regimen for the nose 
and groin will include a 5-day course of nasal mupirocin calcium 2% cream applied inside the nose twice daily, 
plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 10 days20,19. For individuals 
colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit 
fashion twice daily for 7 days.  A standardized educational session on use and accompanying CDC instructional 
frequently asked questions handout and an instructional medication sheet will be provided.   For children < 7 
years of age, we will provide decolonization using 4% chlorhexidine gluconate (soap) used in the shower/bath 
every day for 10 days.  No antimicrobial cream or gargle will be utilized.  If an adult household member or 
sexual partner is colonized at a single site, he or she will receive the soap, rinse and Mupiricin cream.  If he/she 
is not colonized at any body site, no decolonization regimen will be provided.     


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
ENROLLMENT:  
Patient Population/Setting:  
The Johns Hopkins Hospital is located in Baltimore, Maryland, an urban area with a high incidence of 
HIV infection.  Greater than 50% of our clients reside in East Baltimore; > 75% reside within the city limits.  In 
2010 we provided HIV primary and specialty services across all clinics to approximately 3200 patients.  On 
average, 971 individual patients are seen monthly for HIV care alone.  The Moore Clinic site is an outpatient 
clinic located in East Baltimore.  The demographics of the patient population at this clinic parallels the HIV 
epidemic in Maryland: 37% women; 81% African American; mean age of 39 years; and self reported risk group 
of the following:  18% men who have sex with men (MSM); 4% MSM and intravenous drug user (IDU); 38% 
IDU; 33% heterosexual transmission; and 7% other/unknown.    Dr. Farley’s prior work in this clinic identified 
a 15.2% prevalence of MRSA colonization among 500 subjects in this clinic.   
 
Eligibility: See inclusion/exclusion criteria below.  
 
Adult Index Subject Consent: Subjects will be approached after they have been identified through one the 
methods described above in Study Procedures.  The consent process will be completed in a private area of the 
Moore Clinic or CRU.  The consent form will be read aloud to any participant that has difficulty with reading.  
The consent has been developed on a 5th grade reading level.   
 
Adult Household and Sexual Partner Consent: Household members may be consented as individuals or as a 
group with a research assistant reviewing the protocol with the individual or household/family at their chosen 
location (i.e. at home or at the CRU).   Each adult member of the household, 18 years of age and older, will be 
provided with a copy of the consent form and asked to read and sign.  Sexual partners who may be outside the 
home will be consented separately at the location of his/her choosing.   The consent has been developed on a 5th 
grade reading level.   
 
Adolescent Consent: For eligible subjects 14-17 years old we will follow these procedures:  
1. Adult consent, at a 5th grade reading level, will be used and we will follow the same pattern as the adults. 
For our purposes, the adolescent will be asked to identify a parent or legal guardian from whom permission 
for enrollment can be obtained.     
2. After review of the trial (i.e. review the key elements of informed consent), if the adolescent remains 
interested in participation we will encourage the adolescent to discuss the study and decide together with 
their parent or legal guardian about enrollment.  
3. Adolescent will sign the form with the parent or legal guardian signing as a witness. 
 
Parental Permission/Pediatric Assent: For subjects 7 to 13 years old we will follow these procedures:  
1. The study will be discussed with the child including a demonstration of the cotton swab procedure as well as 
the intervention procedures, as applicable. 
2. The child will be provided a Research Assent Form for Children and will be included in the discussion with 
the parent/guardian or legally authorized representative (LAR). 
3. The child will sign the Research Assent Form.  
4. Parent or LAR will provide permission/consent for the child’s participation.   
Parental Permission: For eligible subjects less than 7 years of age we will follow the following procedures:  
1. We are requesting a consent waiver for all children up to 7 years of age.   
2. Parent or LAR will provide permission/consent for the child’s participation. 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
 
Assessment of Adult/Adolescent Protocol Comprehension Prior to Signing Consent: After the consent form 
is read, the RA will evaluate comprehension with three protocol specific questions: 1) what is the name of the 
bacteria or germ that we are trying to get rid of?; 2) How does this study plan to get rid of this bacteria or 
germ?; how will you be assigned to the different options in this study?  We will deem the subject to have an 
acceptable level of comprehension based on their ability to answer those questions.    
 
ALLOCATION: 
Randomization: This study has taken into consideration the guidelines for reporting of clinical trials as 
recommended by the CONSORT report21 to inform the study design (Figure 1).  After recruitment and informed 
consent, patients will undergo pre-randomization screening.  Patients who screen negative for MRSA at this 
point will have completed the protocol.  Patients screening MRSA positive will then be randomized to the two 
possible open-label treatment arms.  Arm 1 will include randomization to standardized decolonization protocol 
of the individual plus household and/or sexual partner(s).  Arm 2 will include randomization to standardized 
decolonization protocol for the individual patient alone.  Randomization will occur through computerized 
random number generation in Stata, version 11.   A simple parallel randomization design will be utilized.  Once 
developed, this randomization scheme will be placed in an individually concealed enveloped.  The RA will not 
be aware of the randomization scheme of the individual envelopes until opened in front of the patient on the day 
of randomization.   
 
Figure 1: SUSTAIN Study Design Overview 
 
 
Data Collection Measures:  
The risk factor questionnaire used in the proposed study has been thoroughly evaluated with over 1000 
subjects (50% with HIV).  Questions have been added or removed as applicable to this patient population.  The 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
questions in the protocol can easily be administered by a study team member in 20 minutes.  The questionnaire 
has been thoroughly evaluated by experts in the field of hospital epidemiology and infection control for content 
validity.  In addition to the subject questionnaire, each instrument contains an additional section for the research 
team to interrogate the patient’s medical record to verify specific pieces of the medical history such as CD4 
count, medication history, viral load, etc.  Adolescents will complete the questionnaire, but for children younger 
than 13, we will have the parent complete the risk factor questionnaire.  Each document ends with a 
microbiology results page for the principle investigator (PI) to complete.     
 
MRSA Screening Procedures:  
Index patients will either 1) self refer by contacting the research assistant after seeing flyers or posted 
signs on the Moore Clinic revolving kiosk screen; 2) be referred from their HIV provider in clinic; or 3) be 
contacted by the research assistant (RA) based on known history of MRSA status from either prior participation 
in MRSA research studies directed by Dr. Farley or through the MRSA screening flag placed in the electronic 
patient record by hospital epidemiology and infection control.   Screening will take place after the index patient 
has contacted our research team to schedule a time for an appointment within the Clinical Research Unit (CRU) 
or at their home based on individual preference. The PI and/or RA will provide information regarding the study, 
answer any questions and obtain informed consent. The PI will be available in person or via telephone to 
answer any questions when an RA is present for the consent. Once enrolled, the RA will assign a study 
identification number (SIN) to the subject.  This will be the primary mode of identification throughout the 
study.  The SIN will appear on the consent form, the questionnaire, as well as all MRSA cultures.  As part of the 
informed consent document, the subject will receive information on how to contact the investigators to discuss 
culture results or any noted treatments that may be related to S. aureus. 
 
During the study visit, the RA will provide the clinician with the necessary swabs for MRSA screening 
and will complete or assist with collection as needed. All patients presenting to the outpatient HIV clinic who 
are willing to undergo testing will be screened by obtaining a swab from the following anatomical sites: anterior 
nares, the throat, the groin/perineum, the vagina (for women) and rectum. The standardized check-list for 
obtaining and processing swabs has been outlined and is available for review in Appendix A.  
 
All swabs will receive a study number pre-printed on a label. The SIN will not identify the patient’s 
name, medical record number or other identifying information. The SIN will be used for data analysis purposes 
and will be recorded on the informed consent documents, the risk factor questionnaire and the surveillance 
swabs. Before sending the swabs, the RA will take a brief “time-out” to reassess that all paperwork is 
completed, swabs appropriately labeled with SIN and medical record #, as appropriate, and that all informed 
consent, questionnaire and swabs all contain the same SIN. 
  
Screening of Adult Household Contacts and Sexual Partners:  
All household contacts in both arms of the study will be offered MRSA screening.  We will complete 
the same procedures for adult household contacts and sexual partners described above.  Contacts will receive 
swabs of the same body sites with each swab labeled with the same study ID # as the index case, but with the 
addition of HC # and SP # to identify household contact and sexual partners respectively.  This will assist us 
with identification and linkage during the molecular epidemiologic evaluation of the isolates.   
 
Screening of Children/Adolescent Household Contacts:  
For children/adolescents under 18, we would screen nares, throat and rectum only. All screening of the 
child up to 12 years of age would be conducted with the parent present.  Adolescents will be asked whether or 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
not they wish for their parent to be present during the rectal swab. All swabs will be conducted in the presence 
of two adults (either RA and parent or two RAs).  Adolescents between 18 years of age and 21 years of age will 
receive the adult screening protocol sites.    
 
Study initiation after screening:  
 
After results for the index subject are obtained, a member of Dr. Farley’s team will contact the subject to 
review the results and randomize the MRSA positive subject into the intervention or control arms.  Subjects in 
the individual arm, will initiate after learning results at the clinic follow-up visit.   For individuals assigned to 
the intervention group, we will schedule a time for a home visit to screen household members or a time in the 
CRU for evaluation.  This screening visit will occur within 14 days of obtaining the original culture results.  All 
household members will then initiate the intervention at the same time.  
 
Microbiological Measures:  
We will utilize the following microbiologic procedures:  Following the current gold standard, each swab 
will be streaked onto CHROMagar-MRSA (BD Diagnostics, Inc.) a selective MRSA medium, and then placed 
in Trypticase soy broth (TSB) with 6.5% NaCl22 to enhance Staphylococcal identification.  CHROMagar-
MRSA plates are incubated at 35˚C and reviewed at 24 hours. Mauve colored colonies on CHROM-MRSA will 
be confirmed as S. aureus (SA) by Gram stain and latex agglutination (Staphaurex Plus [Remel, Lenexa, KS]).  
All MRSA isolates will then undergo molecular characterization using pulse-field gel electrophoresis (PFGE), a 
molecular epidemiologic approach that facilitates identification of patterns in the genetic structure of bacteria to 
determine if transmission has occurred.   Our team has extensive experience with this molecular typing 
mechanism.   
 
FOLLOW-UP: 
Patient Evaluation Time Points: After informed consent, each subject will undergo pre-randomization MRSA 
screening followed by completion of a risk factor screening questionnaire as part of the baseline visit.  Results 
of these tests will be available in 24 hours.  After culture results are available, the study team will randomize the 
subject and provide the required decolonization materials and schedule a start date.  For individuals randomized 
to the arm including their household members/sexual partner, a date will be scheduled to visit the home or 
CRU.   Once the decolonization protocol is complete, a follow-up MRSA screening assessment and adherence 
evaluation will occur (Visit #1).  All subjects will be provided personal hygiene and household cleaning 
instructions. Based on this date, the research assistant will determine the date of the 3 (Visit #2) and 6 (Visit #3) 
month follow-up for subsequent risk factor and microbiologic evaluation.  Study visits and variables collected at 
each visit are summarized in table 1.  
 
 
 
 
Table 1: Timeline for Study Data Collection and Assessments for all participants  
 
Baseline 
Visit 1 
Phone 
Visit 2 
Phone Visit 3 
Data to be collected 
Pre-
Post-
 
3 
 
6 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
Screening 
and 
Consent 
decolonization 
MRSA 
Screening 
check-
in 
month 
check-
in 
month 
Full ACASI Risk Factor 
Questionnaire 
X 
 
 
 
 
 
Abbreviated ACASI Risk 
Factor Questionnaire 
 
 
 
X 
 
X 
MRSA Screening 
X 
X 
 
X 
 
X 
Molecular Evaluation 
X 
 
 
 
 
X 
Telephone contact for 
appointment reminder  
 
 
X 
 
X 
 
 
5. Inclusion/Exclusion Criteria  
 
Eligibility Criteria:  
 
Individuals, 21 years of age and older, of all racial and ethnic groups, receiving care within the JHUAS 
who have a prior history of MRSA colonization are eligible to participate as the index HIV positive subject.  
This person should have at least two members in the household and/or a sexual partner.  A post-consent pre-
randomization screening phase will be completed to ensure subjects are MRSA colonized. In addition to these 
criteria subjects must be willing to be randomized to either arm of the study, including randomization to 
household and/or sexual partner evaluation. Sexual partners and/or household members will also be required to 
provide informed consent.  Subjects and their contacts must have no documented or reported allergies to any 
agent used in the standardized decolonization regimen.  Parental assent will be required for household members 
less than 7 years of age. Exclusion criteria include: allergy to any component of decolonization protocol; 
individuals who live alone and have no active sexual partners; individuals who are unable to provide written 
informed consent.  
 
Recruitment Strategy:  
Study team members will speak with JHUAS providers to discuss the study and seek patient referrals 
(i.e. index patient). A HIPAA waiver will be sought in order to obtain a list of patients with a known history of 
MRSA colonization from Johns Hopkins Hospital Epidemiology and Infection Control Department. In the 
HIPAA waiver, we are asking to contact the patient’s provider in the Moore Clinic to inform of the patient’s 
eligibility for the study prior to the subject seeing his or her provider in clinic.  The provider could then inform 
the patient of their eligibility and ask if we can contact them about the study.  Dr. Farley’s previous work has 
already identified over 70 JHUAS patients with a known history of MRSA colonization. The patients in this 
prior study have agreed to be contacted for future studies when they signed informed consent.  We have 
included details for a HIPPA waiver to evaluate this information in this IRB application.  We have also 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
completed a HIPPA form 3 to document that we have permission to contact the index patient again for future 
studies on MRSA in this patient population.  These index HIV positive patients will be approached for study 
screening during a clinic visit or via telephone to schedule a study visit.  Index HIV positive patients will 
receive a $25.00 gift card on completion of the protocol.  We will offer household members a single gift card of 
$50.00 regardless of the number of participants.    
   
Recruitment of Household Members/Sexual Contacts:  
To avoid disclosure of personal health information (PHI), the index patient will be given the option for a 
home visit by the research team or they and their household members and sexual contacts can be screened at the 
Clinical Research Unit (CRU).  We will work closely with the IRB/DSMB to protect subject’s PHI.  
Recruitment of the primary sexual partner and or family members will occur by referral from the enrolled 
subject.  During the risk factor evaluation, the subject will be asked, “In the last 6 months have you had sex?”   
We then ask several follow-up questions on sexual activity. The enrolled subject will be asked to refer his/her 
primary sexual partner, the person the subject most frequently engages in anal, vaginal or oral sex with, to the 
study.  At no time will study data of either the primary subject or the subject’s sex partner be shared by the 
research team to the other participant regardless of their awareness of the other partner’s status.  Neither the 
screening process, nor the questionnaire reveals any information about HIV status.     
 
6. Drugs/Substances/Devices  
According to the IDSA clinical practice guideline7, the standardized decolonization regimen for the 
adult colonized in either the nose or groin will include a 5-day course of nasal mupirocin calcium 2% applied 
inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower every second day for 
10 days20. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% 
used in a gargle and spit fashion twice daily for 7 days.  A standardized educational session on use and 
accompanying instructional handout will be provided.   Children under 6 months will not be included in the 
study. For children over 6 months and <7 years of age 4% chlorhexidine gluconate (soap) used daily for 10 
days.  For children over the age of 7, we will follow the same protocol as adults.   
 
7. Study Statistics  
 
ANALYSIS:  
Dependent Variable (DV): The DV is a group of mutually exclusive, non-ordered outcomes which include: 
negative for S. aureus, positive for methicillin susceptible S. aureus, positive for methicillin resistant S. aureus.  
 
Independent Variables: A thorough search of the available literature has been completed to develop the risk 
factor questionnaire designed for this study23.   The questionnaire includes: demographic data, medical history, 
sexual history, substance abuse history, as well as healthcare associated and community-based MRSA risk 
factors.   
 
Sample Size: Based on prior studies, it appears that the probability of MRSA colonization at 6 months after 
decolonization ranges from 60% to 80%.  Although an exact effect size is not known for individuals with 
household/sexual partner decolonization, we have considered both feasibility and public health importance. We 
believe the intervention will achieve a 50% reduction in colonization at 6 months (i.e. 30% colonization [0.30] 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
in the arm with individual and household/sexual partner decolonization compared to 60% [0.60] colonization in 
individual alone arm).  Based on these figures and an alpha of 0.05, the total sample size required to 
achieve approximately 80% power is 41 per arm.  We anticipate 20% attrition and will oversample by 9 
subjects per arm, bringing total sample size to 50 per arm.   
 
Statistical Analysis Plan: Demographic variables will be evaluated using chi-square and Fisher’s exact testing 
as appropriate.  Fisher’s exact will also be utilized to compare proportion of persons colonized at 6 months. 
Multinomial logistic regression will be used to determine the odds of subsequent MRSA colonization in the two 
arms and to determine the magnitude of the effect size between the arms.    
 
LIMITATIONS AND PLAN TO ADDRESS:  
 
As with any clinical trial, this study has possible limitations: 
 
1. Confidentiality.  In any study that includes recruitment of individuals with a specific disease process; 
careful discussion of these risks will be required within the informed consent process.  At no time will 
the HIV status of the index patient be disclosed to the household member and/or sexual partner.  
Although persons living with HIV serve as the index patient group, the study is specific to MRSA 
decolonization and subsequent prevention of infection.  The consent form does not mention HIV status 
to avoid disclosure of HIV status to potential family members.   
2. Willingness of participants to participate. This study will require participants to be willing to undergo 
bacterial culture of private anatomical areas.   In a prior JHUAS MRSA evaluation, Dr. Farley obtained 
these specimens in 100% of participants.  The study team will work with providers within the JHUAS to 
recruit subjects with a history of MRSA colonization and/or infection.   
3. Loss to follow-up.  To ensure retention, the researchers have provided the subject with several possible 
methods of communication that the subject may select to best suit his/her individual needs.  We will 
collect name, address and telephone number along with e-mail address as available for each subject. 
This communication will meet all necessary requirements for HIPAA to maintain confidentiality and 
privacy.  As an incentive to encourage follow-up and participation, each subject will be offered a $25.00 
a gift card, which they will receive upon completion of each follow-up visit.  We have also built into our 
sample size calculation a 20% oversampling in case these methods fail.   Research assistants will contact 
the patient daily during the decolonization phase of treatment to ensure fidelity with the prescribed 
treatment regimen and to monitor for adverse drug reactions associated with this treatment regimen.  
4. Access to all community contacts.  We will be unable to test and/or evaluate all possible contacts.  This 
may present a potential for selection bias into the study for individuals who are less sexually active or 
persons whose sexual partner is within the household.  We will encourage all participants to provide 
contact details of all known consistent sexual partners, but will not seek casual sex partners.   
 
Study Timeline:  
The following 3-year study timeline provides an overview of the study preparation period, enrollment and 
follow-up (Table 2).    
 
Table 2: Timeline  
Year  
First 6 
months 
Second 6 
months 
Year 2 
Year 3 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
Task 
Preparation 
Enrollment 
Enrollmen
t 
Follow-
Up 
IRB Process 
 
 
 
 
Identify/Train Research and Lab 
Assistants 
 
 
 
 
Recruitment/Informed 
Consent/Screening 
 
 
 
 
Decolonization and Study Visits  
 
 
 
 
Surveillance for Clinical Infection  
 
 
 
 
Microbiologic Evaluations 
 
 
 
 
Data Entry and Statistical Analysis 
 
 
 
 
Present at Meetings and Publish Data 
 
 
 
 
Preparation of application for R01 
 
 
 
 
 
8. Risks 
Potential Risks:  
The risks for this study are minimal.  There is a very small risk of bleeding associated with swabbing 
mucosal membranes; however, our institution has a long standing history of obtaining nares surveillance 
cultures for MRSA without any reported adverse events.  Standard precautions will be applied for protection of 
the RA and/or clinician during specimen collection.  All swabs will be collected in a private exam room.  A 
clinic gown will be provided for the patient to protect modesty and privacy during collection.   A female 
chaperone will be present at all times when specimens are being obtained from a female patient by a male 
clinician as is standard in our clinic during gynecologic evaluations.    
Allergic reactions to mupiricin and/or chlorhexidine are rare.  Patients with known allergy will be 
excluded from the study.  All agents are FDA approved for the purposes used in this study.  
 
Mupiricin Cream Possible Adverse Effects:  
Local adverse effects may be associated with mupirocin application. Mupirocin ointment or cream may 
commonly cause itching, pain, stinging, and burning. Local effects from the nasal formulation have included 
epistaxis, rhinitis, taste perversion, pharyngitis, burning, and cough.  Gastrointestinal side effects have included 
nausea (1.1%), abdominal pain (<1%), and diarrhea (<1%). Dry mouth has been reported with mupirocin nasal 
(<1%). Nervous system side effects associated with intranasal mupirocin have included headache (9%). 
Dizziness has been reported with mupirocin ointment (<1%). Ocular side effects associated with mupirocin 
nasal ointment have included blepharitis (<1%). 
 
 
Chlorhexidine gluconate Oral Rinse Possible Adverse Effects:  
Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects 
associated with use of Chlorhexidine gluconate rinse. The following oral mucosal side effects were reported 
during placebo-controlled adult clinical trails: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, 
erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each 
occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral 
mucosal symptoms associated with Chlorhexidine gluconate oral rinse are stomatitis, gingivits, glossitis, ulcer, 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the 
oral mucosa have been noted in patients using Chlorhexidine gluconate oral rinse.  There have been cases of 
parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using 
Chlorhexidine gluconate oral rinse. 
 
Chlorhexidine gluconate Topical Soap:  
 
The soap may cause burning and dryness of the skin.   It may cause burning of the eyes. Skin erythema 
and roughness, dryness, sensitization, allergic reactions are possible, but rare. 
  
Protection against Risks:  
The study team recognizes that subjects may seek advice about issues beyond the scope of this study and 
will refer all non-study related health issues to the patient treating clinician.  Any acute, previously 
undiagnosed, infection or any infection that appears to be worsening by a study team member will follow the 
standard procedure of evaluation by either referring the patient to the Johns Hopkins Adult emergency room or 
the Moore Clinic’s acute evaluation clinic after the study team member has contacted the PI and the PI has 
notified the subject’s primary HIV/AIDS clinician about this referral.  For skin and soft tissue infections, the 
RA will accompany the patient to the site of clinical evaluation (i.e. Adult emergency room) in an effort to 
obtain wound cultures from the site.  All other specimens will be obtained through consultation with 
microbiology upon their receipt of the subject’s clinical specimen.   
To protect against breaches of confidentiality regarding the patient’s HIV status we will hold all sexual 
partner evaluations in the CRU in a location outside but adjacent to the Moore Clinic.  Each study team member 
is explicitly aware that we will not disclose HIV status of the referring subject at anytime. Further, we have 
worded the questionnaire in a manner that does not lead on or disclose HIV status in the document.    
Adverse drug reactions will be recorded for each patient and any ADR that results in breach of study 
protocol will be reported to the IRB within 7 days of the event.  None of the agents used in this protocol are 
experimental and each has proven efficacy for use consistent with the intended use in this protocol.   
 
Home Visit Safety Measures for Study Team:  
All home-based study visits will occur with two research assistants.  These RA’s will carry a cell phone 
at all times.  The RA will communicate with the PI before completing a home visit through a home visit 
screening log maintained separately from study materials. This log will identify the subject name and address 
and the time expected to arrive and depart the home.  The RAs will send a text message on arrival and departure 
from the home to the PI or his designee.  Any witnessed child or elder abuse in the home will be reported to 
appropriate authorities once the RA is in a safe place to do so.  
Data Management and Security:  
Study data will be collected and managed using REDCap (http://www.project-redcap.org) which is a 
secure, web-based application designed exclusively to support data capture for research. The Johns Hopkins 
University is a member of the REDCap consortium and this application is freely available to consortium 
members. REDCap provides: 1) an intuitive interface for data entry (with data validation); 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads 
to common statistical packages (SPSS, SAS, Stata, R); 4) procedures for importing data from external sources; 
and 5) advanced features, such as branching logic and calculated fields. To maximize quality control, staff will 
be trained by the PI in all data collection and entry procedures. The PI will have access to all data upon entry 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
into REDCap. The research coordinator will monitor data collection by checking completed questionnaires for 
completeness.  Study team members will have the access codes to enter and retrieve these data based on pre-
determined job requirements.  
 
Development of Data Safety Monitoring Board:  
 
Although not required by the funding agency, the PI and his study team have developed a DSMB to 
monitor the conduct and safety of participants within the trial.   The goals of this DSMB will be review of 
research protocol and study activities, review of data quality and completeness, fidelity to study protocol, 
review of participant recruitment and retention, adverse events.  The board will make recommendations to the 
IRB and the investigative team concerning trial continuation, modification or conclusion. The DSMB will 
consist of the following members:  
• Jackie Campbell, PhD, RN, FAAN: Dr. Campbell is a Professor within the JHU Schools of 
Nursing/Medicine/Public Health, a researcher and clinician in women’s health.  She is the co-director of 
the Johns Hopkins Center for AIDS Research (CFAR) Development Corp.  
• Sarah Szanton, PhD, CRNP: Dr. Szanton is an Associate Professor within the JHU School of Nursing, a 
researcher and clinician in the geriatric population.  She served on the JHU School of Medicine IRB for 
3 years.  
• Jennifer Stewart, PhD, RN: Dr. Stewart is an Assistant Professor within the JHU School of Nursing and 
a researcher whose work focuses on HIV prevention in the African American community.   
 
Plan for Persons Testing Positive for MRSA:  
Upon enrollment, all subjects will be provided a brief structured orientation and education session 
regarding S. aureus and MRSA by the RA.  All patient questions will be answered and educational handouts 
developed by the Centers for Disease Control and Prevention (CDC) will be provided to the patient for 
additional information (available on-line at: http://www.cdc.gov/mrsa/pdf/SHEA-mrsa_tagged.pdf).    
 
Each subject will be given information on how to obtain the results of their cultures.  To avoid 
disclosure of results, the study team will not contact subjects directly to provide MRSA results.  The subject 
will call, e-mail or schedule an appointment with either the RA or PI to receive the results.  Information about 
what a positive test result means will be explained to the patient at that time or the patient may choose to 
discuss in greater detail at the next study visit.   
 
 
9. Benefits  
Potential Benefit of the Proposed Research to the Subject and Others: There may be no direct benefit to 
the subjects in this study; however, information obtained in this research may lead to a better understanding of 
risk associated with MRSA colonization and infection among persons with HIV and HIV/AIDS.  Given the 
intensive monitoring of subjects, it is possible that a subject may benefit from more timely treatment of an 
infection.   
 
10. Payment and Remuneration  
Index HIV positive patients will receive a $25.00 gift card on completion of the protocol.  We will offer 
household members a single gift card of $50.00 regardless of the number of participants.    
 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
11. Costs 
There are no direct costs to the patient in this study.  All subjects will be provided mupiricin, the 
chlorhexidine soap and oral rinse, as applicable.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reference List 
 
 1.  Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, 
Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK, Active Bacterial 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus 
infections in the United States. JAMA 2007;298:1763-71. 
 2.  Crum-Cianflone N, Weekes J, Bavaro M. Recurrent community-associated methicillin-resistant 
Staphylococcus aureus infections among HIV-infected persons: incidence and risk factors. AIDS Patient 
Care STDS 2009;23:499-502. 
 3.  Crum-Cianflone NF, Grandits G, Echols S, Ganesan A, Landrum M, Weintrob A, Barthel R, Agan B. 
Trends and causes of hospitalizations among HIV-infected persons during the late HAART era: what is 
the impact of CD4 counts and HAART use? J Acquir Immune Defic Syndr 2010;54:248-57. 
 4.  Shet A, Mathema B, Mediavilla JR, Kishii K, Mehandru S, Jeane-Pierre P, Laroche M, Willey BM, 
Kreiswirth N, Markowitz M, Kreiswirth BN. Colonization and subsequent skin and soft tissue infection 
due to methicillin-resistant Staphylococcus aureus in a cohort of otherwise healthy adults infected with 
HIV type 1. J Infect Dis 2009;200:88-93. 
 5.  Buehlmann M, Frei R, Fenner L, Dangel M, Fluckiger U, Widmer AF. Highly effective regimen for 
decolonization of methicillin-resistant Staphylococcus aureus carriers. Infect Control Hosp Epidemiol 
2008;29:510-516. 
 6.  Ammerlaan HS, Kluytmans JA, Berkhout H, Buiting A, de Brauwer EI, van den Broek PJ, van Gelderen 
P, Leenders SA, Ott A, Richter C, Spanjaard L, Spijkerman IJ, van Tiel FH, Voorn GP, Wulf MW, van 
Zeijl J, Troelstra A, Bonten MJ. Eradication of carriage with methicillin-resistant Staphylococcus aureus: 
determinants of treatment failure. J Antimicrob Chemother 2011;66:2418-24. 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
 7.  Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, 
Murray BE, Rybak J, Talan DA, Chambers HF. Clinical practice guidelines by the infectious diseases 
society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and 
children. Clin Infect Dis 2011;52:e18-e55. 
 8.  Crum-Cianflone NF, Shadyab AH, Weintrob A, Hospenthal DR, Lalani T, Collins G, Mask A, Mende K, 
Brodine SK, Agan BK. Association of methicillin-resistant Staphylococcus aureus (MRSA) colonization 
with high-risk sexual behaviors in persons infected with human immunodeficiency virus (HIV). Medicine 
(Baltimore) 2011;90:379-89. 
 9.  Shadyab A, Crum-Cianflone N. Methicillin-resistant Staphylococcus aureus (MRSA) infections among 
HIV-infected persons in the era of highly active antiretroviral therapy: a review of the literature. HIV Med 
2012. 
 10.  Graham PL, III, Lin SX, Larson EL. A U.S. population-based survey of Staphylococcus aureus 
colonization. Ann Intern Med 2006;144:318-25. 
 11.  Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, Chen JH, Lin F, Lin J, Phan TH, 
Carleton HA, McDougal LK, Tenover FC, Cohen DE, Mayer KH, Sensabaugh GF, Perdreau-Remington 
F. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus 
clone USA300 in men who have sex with men. Ann Intern Med 2008;148:249-57. 
 12.  Crum-Cianflone NF, Burgi AA, Hale BR. Increasing rates of community-acquired methicillin-resistant 
Staphylococcus aureus infections among HIV-infected persons. Int J STD AIDS 2007;18:521-26. 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
 13.  Skiest DJ, Brown K, Cooper TW, Hoffman-Roberts H, Mussa HR, Elliott AC. Prospective comparison of 
methicillin-susceptible and methicillin-resistant community-associated Staphylococcus aureus infections 
in hospitalized patients. J Infect 2007;54:427-34. 
 14.  Al Rawahi GN, Schreader AG, Porter SD, Roscoe DL, Gustafson R, Bryce EA. Methicillin-resistant 
Staphylococcus aureus nasal carriage among injection drug users: six years later. J Clin Microbiol 
2008;46:477-79. 
 15.  Huang H, Cohen SH, King JH, Monchaud C, Nguyen H, Flynn NM. Injecting drug use and community-
associated methicillin-resistant Staphylococcus aureus infection. Diagn Microbiol Infect Dis 2008;60:347-
50. 
 16.  Lee NE, Taylor MM, Bancroft E, Ruane PJ, Morgan M, McCoy L, Simon PA. Risk factors for 
community-associated methicillin-resistant Staphylococcus aureus skin infections among HIV-positive 
men who have sex with men. Clin Infect Dis 2005;40:1529-34. 
 17.  Mathews WC, Caperna JC, Barber RE, Torriani FJ, Miller LG, May S, McCutchan JA. Incidence of and 
risk factors for clinically significant methicillin-resistant Staphylococcus aureus infection in a cohort of 
HIV-infected adults. J Acquir Immune Defic Syndr 2005;40:155-60. 
 18.  Drapeau CM, Angeletti C, Festa A, Petrosillo N. Role of previous hospitalization in clinically-significant 
MRSA infection among HIV-infected inpatients: results of a case-control study. BMC Infect Dis 
2007;7:36. 


Date: 6/10/13  
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: NA_00079147 
 
 19.  Fritz SA, Hogan PG, Hayek G, Eisenstein KA, Rodriguez M, Epplin EK, Garbutt J, Fraser VJ. Household 
Versus Individual Approaches to Eradication of Community-Associated Staphylococcus aureus in 
Children: A Randomized Trial. Clin Infect Dis 2011. 
 20.  Ammerlaan HS, Kluytmans JA, Berkhout H, Buiting A, de Brauwer EI, van den Broek PJ, van Gelderen 
P, Leenders SA, Ott A, Richter C, Spanjaard L, Spijkerman IJ, van Tiel FH, Voorn GP, Wulf MW, van 
Zeijl J, Troelstra A, Bonten MJ. Eradication of carriage with methicillin-resistant Staphylococcus aureus: 
effectiveness of a national guideline. J Antimicrob Chemother 2011;66:2409-17. 
 21.  Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel 
group randomised trials. Int J Surg 2011;9:672-77. 
 22.  Farley JE, Stamper PD, Ross T, Cai M, Speser S, Carroll KC. Comparison of the BD GeneOhm 
methicillin-resistant Staphylococcus aureus (MRSA) PCR assay to culture by use of BBL CHROMagar 
MRSA for detection of MRSA in nasal surveillance cultures from an at-risk community population. J Clin 
Microbiol 2008;46:743-46. 
 23.  Farley JE, Ross T, Stamper P, Baucom S, Larson E, Carroll KC. Prevalence, risk factors, and molecular 
epidemiology of methicillin-resistant Staphylococcus aureus among newly arrested men in Baltimore, 
Maryland. Am J Infect Control 2008;36:644-50. 
 
 

ICF_000.pdf: 
 
 
Informed Consent Index Cover Page 
 
Title: Stop Community MRSA Colonization Among Patients (SUSTAIN) 
ICF Date: 8/5/2014 
NCT: NCT02029872 
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 1 of 10 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Protocol Title: Stop Community MRSA Colonization among Patients (SUSTAIN) 
 
 
 
Application No.:  NA_00079147 
 
Sponsor:  Robert Wood Johnson Foundation 
 
 
Principal Investigator: Jason E. Farley, PhD, MPH, NP 
525 N. Wolfe Street, Room 525 
Baltimore, MD 21205 
Office: 410-502-7563  
Fax: 443-873-5036 
  
1. 
What you should know about this study: 
 You are being asked to join a research study.  
 This consent form explains the research study and your part in the study.   
 Please read it carefully and take as much time as you need.  
 Ask your study doctor or the study team to explain any words or information in this informed 
consent that you do not understand. 
 You are a volunteer.  If you join the study, you can change your mind later. You can decide not to 
take part or you can quit at any time. There will be no penalty or loss of benefits if you decide to quit 
the study.   
 During the study, we will tell you if we learn any new information that might affect whether you 
wish to continue to be in the study. 
 Ask your study doctor or the study team to explain any words or information in this informed 
consent that you do not understand. 
 For clinical trials: A description of this clinical trial will be available at www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search the Web site at any time. 
 If you have clinical tests done as part of this research study, a statement will be added to your 
medical record that you are in this research study. Results from any clinical tests you have will be 
included in your medical record.  Doctors outside of Johns Hopkins may not have access to this 
information.  You can ask the research team to send this information to any of your doctors.  
 If children and adults can join this study, the word “you” in this consent form will refer to both you    
and your child. 
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
 
 
 
 
 
Patient I.D. plate 
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 2 of 10 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
 Biospecimens will be collected in this study.  Biospecimens may include any of the following: 
blood, tissue, saliva, urine, bone marrow, cells, etc.  Most biospecimens contain DNA, which is the 
genetic code for each person. 
 When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The 
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, 
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All 
Children’s Hospital. 
 
2. 
Why is this research being done? 
This research is being done to learn more about an approach to remove Methicillin resistant 
Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient settings and 
among their household members and sexual partners. 
 
MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make people very 
sick.  The bacteria have been seen in a high number of persons in the Baltimore area and in hospitals 
throughout the country.   MRSA can be spread from person to person, particularly in homes and among 
family members and sexual partners.   
 
There are three things we hope to learn from this research study:  
1) First, we want to find a way to prevent MRSA infections in outpatient settings.  By asking questions, 
we want to look at the things that may increase the risk of having this type of bacteria in you and 
your family members.   
2) Second, we have soaps and oral rinses (Chlorhexidine) and medications (antibiotics; Mupiricin 
ointment) that have been shown to be effective at removing MRSA.  We want to determine if these 
antibiotics and soaps are best used for everyone in the household or only the individual with known 
MRSA.   
3) Third, we want to learn more about the bacteria by looking at it on the inside.  We will do laboratory 
tests on samples we collect, to learn how MRSA bacteria grow, reproduce and how it develops to 
behave differently than other types of MRSA bacteria. 
 
People who carry the MRSA bacteria at any location on their body may join this study.  
 
How many people will be in this study? 
About 520 men, women and children could take part in this study in Baltimore City.  About 50 
participants will be assigned to the individual group and we anticipate screening about 4 members of the 
household/sex partner in this group.  About 50 people will be enrolled in the household/sex partner 
group and we anticipate screening and treating 4 members of the household in this group.  We believe 
500 individuals in total will be enrolled in this study.  Each person will be in this study for 
approximately 6 months.  
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things: 
 
1) Complete a brief survey.  This questionnaire will ask you for some demographic information and 
questions about your health history. 
2) Allow us to look at the electronic or paper medical chart, if part of the Johns Hopkins Medical 
Institutions.  This will include evaluating your medication, prior laboratory studies and past clinician 
visits.  
3) Allow us to collect:   


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 3 of 10 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
 If you are an adult over 18, a cotton swab of your nose, throat, groin (area between genitals and 
rectum), the rectum, and the vagina (for women).  A single new swab is placed in each location 
and rotated in a circle to pick up cells.   
 Male and female children, under the age of 18 will receive a swab of their nose, throat and 
rectum only.  
 All participants, regardless of age will receive a cotton swab of any open or draining skin bump 
or wound.  
 
Cotton swabs will be processed at the Johns Hopkins Hospital laboratory for the presence of the MRSA  
bacteria. 
 If a wound is cultured and determined to be infected by MRSA, you and your primary medical 
provider will be notified of the result.   
4) Discuss the study with your household member and sexual partners and inform them that the study 
team will be in contact with them. 
 
 If your samples are positive for MRSA you and your household members and sexual partner will 
qualify for study participation.  You will have completed the study if your MRSA result is 
negative.     
 If you have an infection caused by MRSA, the study team will notify you and/or your treatment 
team or your healthcare provider who will determine the need for treatment of the infection.  
 
If your MRSA result is positive you will then be assigned to one of two groups randomly (by chance, 
like “flipping a coin”).  The same exact study procedures are followed for both groups except for those 
who receive MRSA testing, soap and antibiotics.  These two groups are known as the individual group 
and the household group.   
 
 Individual group: Fifty participants will be assigned to this group. Household members may receive 
screening if they choose, but will not receive soap or medication if you are assigned to this group. 
Only you will receive soap and medication. We ask that you not share this with your family.  MRSA 
screening and use of the soap/antibiotic will focus only on you.  After completion of the final study 
visit your household members/sexual partner may receive treatment.  
 
 Household/sex partner group: Fifty participants will be assigned to this group.  Household members 
and your main sexual partner will be able to participate in this group.  We will set up a time that is 
convenient for you and your household members to participate.  You will have the option of 
scheduling an appointment at Johns Hopkins or two members of the study team will make a home 
visit.  It is your choice based on what best suits your needs.  Soap and medication will be provided 
for the entire household based on age appropriate treatment plan.   
 
After your group assignment:  
Once you have been assigned to your specific group and your household members and/or sexual partner 
has agreed to be contacted, the research assistant will work with you to schedule either a home visit or 
clinic visits for your household members and sexual partner.  This will need to be completed prior to 
receiving your study medications.  This should occur within 7 days of your signing consent for 
participation.   
 
You will be notified about your result before we screen anyone else in your household.  If you are 
MRSA negative, you and your household members and/or sexual partner do not qualify for the study.  
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 4 of 10 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
Once you are screened and we discuss your MRSA results with you by phone, we will want to discuss 
the study with your household members and/or sexual partner if you are MRSA positive.  As you 
and your household and/or sexual partner are assigned, as a group, to the intervention or control parts of 
this study, we will ask you to make contact with your household and/or sexual partner when we inform 
you of your results.  It is your choice if you would like to do that during our call to discuss your results 
or at another appropriate time.  Once permission to discuss the study is granted by your household 
members and/or sexual partner, the study team member would schedule a time in clinic or during a 
home visit to enroll your household members and/or sexual partner.  For your household members 
and/or sexual partner, we will notify each of these individuals separately of his/her MRSA result and 
will inform the adult participant about the status of children during the scheduled time after the 
screening/enrollment visit.  Once your family has been screened, it usually takes about 48 hours after the 
MRSA test result reaches the lab to have the result.   
 
If your family member has a wound, we will notify the person (or parent/legally authorized 
representative for a child).  If the family member does not have a primary medical provider, we will 
provide details about clinic locations that would offer treatment for this infection.   
 
Treatment regimen to remove MRSA colonization:  
Everyone will receive mupiricin ointment for the nose twice daily for 7 days.  Additionally, you will 
have chlorhexidine rinse for your throat twice daily for 7 days if you have MRSA in your throat.  
Everyone will be provided chlorhexidine soap to use in the bath/shower daily for 7 days.  All of these 
treatments are used during the same 7 day period.  You will be provided instruction sheets detailing how 
to use each of the treatment regimens. You will be rescreened for MRSA upon completion and, if 
positive, will receive an additional 7 days of MRSA treatment, followed by rescreening.   
 
Request to collect and store biospecimens for future research   
As part of this research study, we would like to ask you to let us store your biospecimens, the MRSA 
bacteria, if found, and health information for future MRSA research.  This may include, comparing the 
bacteria on your swab to bacteria from sexual partners or in patients from other local hospitals.  The 
same rules and procedures to protect your privacy discussed here will be taken for all future research. 
 
The study doctor can provide you with additional information if you have questions. Also, further 
information about our use of your biospecimens can be found in this consent document under the 
heading What happens to Data and Biospecimens that are collected in the study?. 
 
Will you allow us to store the biospecimens which are the swabs that we collect for this study for use 
in future research? 
YES    ________________________    
  
  
 
Signature of Participant  
  
  
  
  
 
 
NO     __________________   
  
  
 
Signature of Participant  
 
   
How long will you be in the study? 
You will be in this study for just over 6 months.  This will include your baseline screening visit, baseline 
follow-up, your treatment period of 7 days, visit 1 (post treatment) followed by a follow up period of 6 
months.   
 
 
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
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Approved Aug. 5, 2014 
Timeline for Study Data Collection and Assessments for all participants 
 
 
Baseline  
Screening 
 
Results 
Follow-up 
 
Treatment 
Initiation 
Visit 1 
Phone 
Visit 2 
Phone 
Visit 3 
Data to be collected 
Screening  
and  
Consent 
 
 
Post- 
Treatment 
MRSA 
Screening 
check-in 
3  
month 
check-in 
6  
month 
Full Risk Factor 
Questionnaire 
X 
 
 
 
 
 
 
 
Abbreviated  
Risk Factor 
Questionnaire 
 
 
 
 
 
X 
 
X 
MRSA Screening 
X 
 
 
X 
 
X 
 
X 
Molecular 
Evaluation 
X 
 
 
 
 
 
 
X 
Telephone contact 
X   
(with family) 
X  
(with family) 
 
 
X 
 
X 
 
Begin MRSA 
Soap/Antibiotics 
 
 
X 
 
 
 
 
 
 
4. 
What are the risks or discomforts of the study? 
The risks for this study are minimal; however, you do not require treatment for MRSA colonization.  If 
you do nothing, you and your family, may live the remainder of your lives without an MRSA infection.  
If you have a history of MRSA infection, this could reduce your chance of repeat infection, but that is 
not guaranteed.    
 
Risk of Obtaining the MRSA Swabs:  
There is a very small risk of bleeding associated with swabbing mucosal membranes; however, our 
institution has a long standing history of obtaining nares surveillance cultures for MRSA without any 
reported adverse events.  All swabs will be collected in a private exam room if at the hospital or in an 
appropriate area in the home.  A female chaperone will be present at all times when specimens are being 
obtained from a female patient by a male clinician as is the standard in our clinic during gynecologic 
evaluations.    
 
Risk with Study Medications and Soaps/Oral Rinse:  
Allergic reactions to mupiricin ointment and/or chlorhexidine soap or oral rinse are rare.  Patients with a 
known allergy will be excluded from the study.  All agents are FDA cleared for the purposes used in this 
study.  Below you will find a detailed listing of possible side effects.   
 
Mupiricin Ointment:  
Local adverse effects may be associated with mupirocin application in the nose. Mupirocin ointment or 
cream may commonly cause a sensation of itching, pain, stinging, and burning. Local effects from the 
nasal cream have included minor nose bleeding, runny nose, brief changes in taste, dry mouth, sore 
throat, burning, and cough.  Stomach side effects may include nausea, abdominal pain, and diarrhea. 
Nervous system side effects associated with intranasal mupirocin have included headache. Dizziness has 
been reported with mupirocin ointment. Ocular side effects associated with mupirocin nasal ointment 
have included a possible inflammation in the eye. 
 
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 6 of 10 
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Approved Aug. 5, 2014 
Chlorhexidine gluconate Oral Rinse Possible Adverse Effects:  
Oral irritation and local allergy-type symptoms have been reported as side effects associated with use of 
Chlorhexidine gluconate rinse. The following oral side effects were reported during adult clinical trails: 
painful ulcers, infection of the gums, trauma, redness, peeling of skin in your mouth, coated tongue, 
changes in tongue texture. Each occurred at a frequency of less than 1% (1 out of 100). Among post 
marketing reports, the most frequently reported oral mucosal symptoms associated with Chlorhexidine 
gluconate oral rinse are swelling and possible pain/inflammation in tongue and gums, ulcer, dry mouth, 
swelling of tongue, and numbness of mouth. Minor irritation and superficial peeling of skin of the oral 
mucosa have been noted in patients using Chlorhexidine gluconate oral rinse.   
 
Chlorhexidine gluconate (Hibiclens) Topical Soap Possible Adverse Effects:  
The soap may cause burning and dryness of the skin.   It may cause burning of the eyes. Skin erythema 
and roughness, dryness, sensitization, allergic reactions are possible, but rare. 
 
Interviews/Questionnaires:  
You may get tired or bored when we are asking you questions or when you are completing 
questionnaires. You do not have to answer any question you do not want to answer.  To protect the 
privacy of each individual family member, all interviews and questionnaires of the family will be 
conducted privately.   
 
Home Visit: 
If, as part of the study, we visit your home, Maryland law requires us to tell the local or state authorities 
if we suspect abuse or neglect of a child or dependent adult. If you tell us that you plan to harm 
someone, we are required to contact the police. We may also warn the person who is at risk. 
 
5. 
Are there risks related to pregnancy? 
Pregnant women are not eligible to participate in this study.  Please tell us if you are pregnant or believe 
you may be pregnant.  Please inform us if you become pregnant while participating in this study.  While 
it is not expected, this research may hurt an embryo or fetus in ways we do not currently know.  
 
6. 
Are there benefits to being in the study? 
There is no direct benefit to you from being in this study. If you take part in this study, you may help 
others in the future and will improve our understanding of how to prevent MRSA transmission in 
families. 
 
7. 
What are your options if you do not want to be in the study? 
If you decide not to join this study, other options are available.  You do not have to join this study to get 
treatment.  You can speak with your medical provider to discuss each of the options available to you in 
this study.   
 
You do not have to join this study.  If you do not join, your care at Johns Hopkins will not be affected. 
 
8. 
Will it cost you anything to be in this study?   
You will receive a separate Insurance and Research Participant Financial Responsibility Information 
Sheet.  
 
This Sheet will give you the following information: 
 The procedures, tests, drugs or devices that are part of this research and that will be paid for by 
the study (no cost to you).   
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 7 of 10 
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 The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  If 
you have health insurance, you will be responsible for any co-pays or deductibles not covered by 
your insurance.  
 
9. 
Will you be paid if you join this study? 
You will receive a $25.00 gift card completing the treatment course and a $25.00 gift card at the end of 
the study.  One gift card of $50 will be available for the household after completing treatment and 
$50.00 gift card at the completion of the study if you are assigned to the household/sex partner treatment 
group only.  If you are assigned to the individual group arm of the study, your household/sex partners 
will be offered free screening but they will not receive any payment for the study. 
 
You may be required to provide your Social Security number to be paid.  If your payment for study 
participation exceeds $600 per year, this information must be reported to the Internal Revenue Service. 
 
10. Can you leave the study early? 
 You can agree to be in the study now and change your mind later. 
 If you wish to stop, please tell us right away. 
 Leaving this study early will not stop you from getting regular medical care.  
 If you leave the study early, Johns Hopkins may use or give out your health information that it 
already has if the information is needed for this study or any follow-up activities. 
 
11. Why might we take you out of the study early?  
You may be taken out of the study if: 
 Staying in the study would be harmful. 
 You need treatment not allowed in the study. 
 You fail to follow instructions. 
 You become pregnant. 
 The study is cancelled. 
 There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
already has if the information is needed for this study or any follow-up activities. 
 
12. How will your privacy be protected? 
Johns Hopkins has rules to protect information about you.  Federal and state laws also protect your 
privacy.  By signing this form you provide your permission, called your “authorization,” for the use and 
disclosure of information protected by the Privacy Rule. 
 
The research team working on the study will collect information about you.  This includes things learned 
from the procedures described in this consent form.  They may also collect other information including 
your name, address, date of birth, and information from your medical records.  This could include 
information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health 
problems. 
 
The research team will know your identity and that you are in the research study.  Other people at Johns 
Hopkins, particularly your doctors, may see or give out your information.  We make this information 
available to your doctors for your safety. 
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 8 of 10 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
People outside of Johns Hopkins may need to see your information for this study.  Examples include 
government groups (such as the Food and Drug Administration), safety monitors, other sites in the study 
and companies that sponsor the study. 
 
We cannot do this study without your permission to use and give out your information.  You do not have 
to give us this permission.  If you do not, then you may not join this study. 
 
We will use and disclose your information only as described in this form and in our Notice of Privacy 
Practices; however, people outside Hopkins who receive your information may not be covered by this 
promise.  We try to make sure that everyone who needs to see your information keeps it confidential – 
but we cannot guarantee this. 
 
The use and disclosure of your information has no time limit. You may cancel your permission to use 
and disclose your information at any time by notifying the Principal Investigator of this study by phone 
or in writing.  If you contact the Principal Investigator by phone, you must follow-up with a written 
request that includes the study number and your contact information.  The Principal Investigator’s name, 
address, phone and fax information are on page one of this consent form.   
 
If you do cancel your permission to use and disclose your information, your part in this study will end 
and no further information about you will be collected. Your cancellation would not affect information 
already collected in the study. 
 
13. Will the study require any of your other health care providers to share your 
health information with the researchers of this study? 
As a part of this study, the researchers may ask to see your health care records from your other 
healthcare providers. You will be asked to give us a list of other health care providers that you used.   
 
14. What treatment costs will be paid if you are injured in this study?  
Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being 
in the study.  However, medical care at Johns Hopkins is open to you as it is to all sick or injured people.   
 
 If you have health insurance:  The costs for any treatment or hospital care you receive as the result of 
a study-related injury will be billed to your health insurer. Any costs that are not paid for by your 
health insurer will be billed to you.  
 
 If you do not have health insurance:  You will be billed for the costs of any treatment or hospital care 
you receive as the result of a study-related injury. 
 
By signing this form you will not give up any rights you have to seek compensation for injury.  
 
15. What other things should you know about this research study? 
 
a. What is the Institutional Review Board (IRB) and how does it protect you?  
The Johns Hopkins Medicine IRB is made up of: 
 Doctors 
 Nurses 
 Ethicists 
 Non-scientists 
 and people from the local community.  
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 9 of 10 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
The IRB reviews human research studies. It protects the rights and welfare of the people taking part 
in those studies.  You may contact the IRB if you have questions about your rights as a participant or 
if you think you have not been treated fairly.  The IRB office number is 410-955-3008. You may 
also call this number for other questions, concerns or complaints about the research.  
 
b. What do you do if you have questions about the study?    
Call the principal investigator, Dr. Jason Farley at 410-502-7563. If you wish, you may contact the 
principal investigator by letter or by fax.  The address and fax number are on page one of this 
consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the 
IRB office at 410-955-3008.   
 
c. What should you do if you are injured or ill as a result of being in this study?  
If you think you are injured or ill because of this study, call Dr. Jason Farley at 410-502-7563 (office 
line) or 443-326-5759 (clinic line) during regular office hours.  
 
If you have an urgent medical problem related to your taking part in this study, call Dr. Jason 
Farley at 443-326-5759 during regular office hours and at 410-258-4506 (cell phone) after hours and 
on weekends.  
  
d. What happens to Data and Biospecimens that are collected in the study?  
Johns Hopkins and our research partners work to understand and cure diseases. The biospecimens 
and/or data, tissue, blood and specimens collected from you during this study are important to both 
this study and to future research. 
 
If you join this study: 
 You will not own the data, or the tissue, blood, or other specimens given by you to the 
investigators for this research. 
 Both Johns Hopkins and any sponsor of this research may study your data and the tissue, blood 
or other specimens collected from you. 
 If data, tissue, blood, or other specimens are in a form that identifies you, Johns Hopkins may 
use them for future research only with your consent or IRB approval. 
 If data, tissue, blood or other specimens are in a form that we believe does not identify you, they 
may be shared with other academic medical centers, non-profit organizations, corporate sponsors 
and other commercial companies without your consent or IRB approval.  
 You will not own any product or idea created by the researchers working on this study. 
 You will not receive any financial benefit from the creation, use or sale of such a product or idea. 
 
16. Assent Statement 
This research study has been explained to my child in my presence in language my child can understand.  
He/she has been encouraged to ask questions about the study now and at any time in the future. 
 
 
 
 
 
 
 
 
 
 


 
 
Date: Aug. 05, 2014 
Principal Investigator:  Jason E. Farley PhD, MPH, CRNP 
Application No.:  NA_00079147 
 
Page 10 of 10 
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Approved Aug. 5, 2014 
17. What does your signature on this consent form mean? 
 
Your signature on this form means that: 
 you understand the information given to you in this form  
 you accept the provisions in the form 
 you agree to join the study  
 
You will not give up any legal rights by signing this consent form.  
 
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
__________________________________________________________________________________________________________________________ 
Signature of Participant                                                      (Print Name)                                                          Date/Time                                           
 
_________________________________________________________________________________________ 
Signature of Person Obtaining Consent                              (Print Name)                                                          Date/Time                               
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL 
INVESTIGATOR; A COPY MUST BE GIVEN TO THE PARTICIPANT; AND, IF YOU ARE NOT USING 
EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS NO 
MEDICAL RECORD EXISTS OR WILL BE CREATED).  
 
 
 
 
 


 
 
Informed Consent Family Cover Page 
 
Title: Stop Community MRSA Colonization Among Patients (SUSTAIN) 
ICF Date: 8/5/2014 
NCT: NCT02029872 
 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
Page 1 of 9 
Combined Informed Consent/Authorization October 2013 Version 14 
 
Approved Aug. 5, 2014 
 
 
 
 
 
 
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
FAMILY – HOUSEHOLD MEMBER – PARTNER CONSENT – TREATMENT ARM  
 
Protocol Title:  
 
Stop Community MRSA Colonization among Patients (SUSTAIN) 
 
Application No.: 
NA_00079147 
 
Sponsor: 
Robert Wood Johnson Foundation 
 
Principal Investigator: Jason E. Farley, PhD, MPH, NP, FAAN 
525 N. Wolfe Street, Room 525 
Baltimore, MD 21205 
Office: 410-502-7563  
Fax: 443-873-5036   
  
 
 
1. 
What you should know about this study: 
 You are being asked to join a research study. 
 This consent form explains the research study and your part in the study.   
 Please read it carefully and take as much time as you need.  
 Please ask questions at any time about anything you do not understand.   
 You are a volunteer.  If you join the study, you can change your mind later. You can decide not to 
take part or you can quit at any time. There will be no penalty or loss of benefits if you decide to quit 
the study.   
 During the study, we will tell you if we learn any new information that might affect whether you 
wish to continue to be in the study. 
 Ask your study doctor or the study team to explain any words or information in this informed 
consent that you do not understand. 
 For clinical trials: A description of this clinical trial will be available at www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search the Web site at any time. 
 If you have clinical tests done as part of this research study, a statement will be added to your 
medical record that you are in this research study. Results from any clinical tests you have will be 
included in your medical record.  Doctors outside of Johns Hopkins may not have access to this 
information.  You can ask the research team to send this information to any of your doctors.  
 If children and adults can join this study, the word “you” in this consent form will refer to both you    
and your child. 
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
 
 
 
 
 
Patient I.D. plate 
 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
Page 2 of 9 
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Approved Aug. 5, 2014 
 Biospecimens will be collected in this study.  Biospecimens may include any of the following: 
blood, tissue, saliva, urine, bone marrow, cells, etc.  Most biospecimens contain DNA, which is the 
genetic code for each person. 
 When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The 
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, 
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All 
Children’s Hospital. 
 
2. 
Why is this research being done? 
This research is being done to learn more about an approach to remove Methicillin resistant 
Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient settings and 
among their household members and sexual partners. 
 
MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make people very 
sick.  The bacteria have been seen in a high number of persons in the Baltimore area and in hospitals 
throughout the country.   MRSA can be spread from person to person, particularly in homes and among 
family members and sexual partners.   
 
There are three things we hope to learn from this research study:  
1) First, we want to find a way to prevent MRSA infections in outpatient settings.  By asking questions, 
we want to look at the things that may increase the risk of having this type of bacteria in you and 
your family members.   
2) Second, we have soaps and oral rinses (Chlorhexidine) and medications (antibiotics; Mupiricin 
ointment) that have been shown to be effective at removing MRSA.  We want to determine if these 
antibiotics and soaps are best used for everyone in the household or only the individual with known 
MRSA.   
3) Third, we want to learn more about the bacteria by looking at it on the inside.  We will do laboratory 
tests on samples we collect, to learn how MRSA bacteria grow, reproduce and how it develops to 
behave differently than other types of MRSA bacteria. 
 
How many people will be in this study? 
About 520 men, women and children could take part in this study in Baltimore City.  About 50 
participants will be assigned to the individual group and we anticipate screening about 4 members of the 
household/sex partner in this group.  About 50 people will be enrolled in the household/sex partner 
group and we anticipate screening and treating 4 members of the household in this group.  We believe 
500 individuals in total will be enrolled in this study.  Each person will be in this study for 
approximately 6 months. 
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things: 
 
1) Complete a brief survey.  This questionnaire will ask you for some demographic information and 
questions about your health history. 
2) Allow us to look at the electronic or paper medical chart, if part of the Johns Hopkins Medical 
Institutions.  This will include evaluating your medication, prior laboratory studies and past clinician 
visits.  
3) Allow us to collect:   
 If you are an adult over 18, a cotton swab of your nose, throat, groin (area between genitals and 
rectum), the rectum, and the vagina (for women).  A single new swab is placed in each location 
and rotated in a circle to pick up cells.   


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
Page 3 of 9 
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 Male and female children, under the age of 18 will receive a swab of their nose, throat and 
rectum only.  
 All participants, regardless of age will receive a cotton swab of any open or draining skin bump 
or wound. 
 
Cotton swabs will be processed at the Johns Hopkins Hospital laboratory for the presence of the 
MRSA bacteria. 
We will notify each member of your household individually and will inform the adult participant about 
the status of children during the scheduled phone call after the enrollment visit.  Once you have been 
screened, it usually takes about 48 hours after the MRSA test result reaches the lab to have the result.   
 
If a wound is cultured and determined to be infected by MRSA, you and your primary medical provider 
will be notified of the result.  If your family member has a wound, we will notify the person (or 
parent/legally authorized representative for a child).  If the family member does not have a primary 
medical provider, we will provide details about clinic locations that would offer treatment for this 
infection.   
 
 You have been assigned to the intervention part of this study.  This includes use of antibiotics for the 
nose, if needed, and special soap for everyone who agrees to participate in your home.   
 If you have an infection caused by MRSA, the study team will notify you and/or your treatment team 
or your healthcare provider who will determine the need for treatment of the infection.  
 
How long will you be in the study? 
You will be in this study for just over 6 months.  This will include your baseline screening visit, baseline 
follow-up, your treatment period of 7 days, visit 1 (post treatment) followed by a follow up period of 6 
months.   
 
       Timeline for Study Data Collection and Assessments for all participants  
 
 
Index 
Screening 
  Index 
Follow-
up 
Baseline  
Screening 
(Household) 
 
Results 
Follow-
up 
 
 
Treatment 
Initiation 
Visit  
1 
Phone 
Visit  
2 
Phone 
Visit  
3 
Data to be 
collected 
 
 
Screening  
and  
Consent 
 
 
Post-
Treatment 
MRSA 
Screening 
check-in 
3  
month 
 check-in 
6  
month 
Full  
Risk Factor 
Questionnaire 
 
 
X 
 
 
 
 
 
 
 
Abbreviated  
Risk Factor 
Questionnaire 
 
 
 
 
 
 
 
X 
 
X 
MRSA  
Screening 
 
 
X 
 
 
X 
 
X 
 
X 
Molecular 
Evaluation 
 
 
X 
 
 
 
 
 
 
X 
Telephone  
contact 
 
 
 
X 
 
 
X 
 
X 
 
Begin MRSA 
Soap/ 
Antibiotics 
 
 
 
 
 
X 
 
 
 
 
 
 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
Page 4 of 9 
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Approved Aug. 5, 2014 
Treatment regimen to remove MRSA colonization:  
Everyone will receive mupiricin ointment for the nose twice daily for 7 days.  Additionally, you will 
have chlorhexidine rinse for your throat twice daily for 7 days if you have MRSA in your throat.  
Everyone will be provided chlorhexidine soap to use in the bath/shower daily for 7 days.  All of these 
treatments are used during the same 7 day period.  You will be provided instruction sheets detailing how 
to use each of the treatment regimens. You will be rescreened for MRSA upon completion and, if 
positive, will receive an additional 7 days of MRSA treatment, followed by rescreening.   
 
Request to collect and store biospecimens for future research   
As part of this research study, we would like to ask you to let us store your biospecimens, the MRSA 
bacteria, if found, and health information for future MRSA research.  This may include, comparing the 
bacteria on your swab to bacteria from sexual partners or in patients from other local hospitals.  The 
same rules and procedures to protect your privacy discussed here will be taken for all future research. 
 
The study doctor can provide you with additional information if you have questions. Also, further 
information about our use of your biospecimens can be found in this consent document under the 
heading What happens to Data and Biospecimens that are collected in the study?. 
 
Will you allow us to store the biospecimens which are the swabs that we collect for this study for use 
in future research? 
YES    ________________________     
   
   
 
Signature of Participant      
   
   
   
 
 
NO     __________________   
  
  
 
Signature of Participant 
 
4. 
What are the risks or discomforts of the study? 
The risks for this study are minimal however, you do not require treatment for MRSA colonization.  If 
you do nothing, you and your family, may live the remainder of your lives without an MRSA infection.  
If you have a history of MRSA infection, this could reduce your chance of repeat infection, but that is 
not guaranteed.    
 
Risk of Obtaining the MRSA Swabs:  
There is a very small risk of bleeding associated with swabbing mucosal membranes however, our 
institution has a long standing history of obtaining nares surveillance cultures for MRSA without any 
reported adverse events.  All swabs will be collected in a private exam room if at the hospital or in an 
appropriate area in the home.  A female chaperone will be present at all times when specimens are being 
obtained from a female patient by a male clinician as is the standard in our clinic during gynecologic 
evaluations.    
 
Risk with Study Medications and Soaps/Oral Rinse:  
Allergic reactions to mupiricin ointment and/or chlorhexidine soap or oral rinse are rare.  Patients with 
known allergy will be excluded from the study.  All agents are FDA cleared for the purposes used in this 
study.  Below you will find a detailed listing of possible side effects.   
 
Mupiricin Ointment:  
ocal adverse effects may be associated with mupirocin application in the nose. Mupirocin ointment or 
cream may commonly cause a sensation of itching, pain, stinging, and burning. ocal effects from the 
nasal cream have included minor nose bleeding, runny nose, brief changes in taste, dry mouth, sore 
throat, burning, and cough.  Stomach side effects may include nausea, abdominal pain, and diarrhea. 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
Page 5 of 9 
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Approved Aug. 5, 2014 
Nervous system side effects associated with intranasal mupirocin have included headache. Dizziness has 
been reported with mupirocin ointment. Ocular side effects associated with mupirocin nasal ointment 
have included a possible inflammation in the eye. 
 
Chlorhexidine gluconate Oral Rinse Possible Adverse Effects:  
Oral irritation and local allergy-type symptoms have been reported as side effects associated with use of 
Chlorhexidine gluconate rinse. The following oral side effects were reported during adult clinical trails: 
painful ulcers, infection of the gums, trauma, redness, peeling of skin in your mouth, coated tongue, 
changes in tongue texture. Each occurred at a frequency of less than 1% (1 out of 100). Among post 
marketing reports, the most frequently reported oral mucosal symptoms associated with Chlorhexidine 
gluconate oral rinse are swelling and possible pain/inflammation in tongue and gums, ulcer, dry mouth, 
swelling of tongue, and numbness of mouth. Minor irritation and superficial peeling of skin of the oral 
mucosa have been noted in patients using Chlorhexidine gluconate oral rinse.   
 
Chlorhexidine gluconate (Hibiclens) Topical Soap Possible Adverse Effects:  
The soap may cause burning and dryness of the skin.   It may cause burning of the eyes. Skin erythema 
and roughness, dryness, sensitization, allergic reactions are possible, but rare. 
 
Interviews/Questionnaires:  
You may get tired or bored when we are asking you questions or when you are completing 
questionnaires. You do not have to answer any question you do not want to answer.  To protect the 
privacy of each individual family member, all interviews and questionnaires of the family will be 
conducted privately.   
 
Home Visit: 
If, as part of the study, we visit your home, Maryland law requires us to tell the local or state authorities 
if we suspect abuse or neglect of a child or dependent adult. If you tell us that you plan to harm 
someone, we are required to contact the police. We may also warn the person who is at risk. 
 
5. 
Are there risks related to pregnancy? 
Pregnant women are not eligible to participate in this study.  Please tell us if you are pregnant or believe 
you may be pregnant.  Please inform us if you become pregnant while participating in this study.  While 
it is not expected, this research may hurt an embryo or fetus in ways we do not currently know.  
 
6. 
Are there benefits to being in the study? 
There is no direct benefit to you from being in this study. If you take part in this study, you may help 
others in the future and will improve our understanding of how to prevent MRSA transmission in 
families. 
 
7. 
What are your options if you do not want to be in the study? 
If you decide not to join this study, other options are available.  You do not have to join this study to get 
treatment.  You can speak with your medical provider to discuss each of the options available to you in 
this study.   
 
You do not have to join this study.  If you do not join, your care at Johns Hopkins will not be affected. 
 
8. 
Will it cost you anything to be in this study?   
You will receive a separate Insurance and Research Participant Financial Responsibility Information 
Sheet. 
 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
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This Sheet will give you the following information: 
 
 The procedures, tests, drugs or devices that are part of this research and that will be paid for by 
the study (no cost to you).   
 
 The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  If 
you have health insurance, you will be responsible for any co-pays or deductibles not covered by 
your insurance.  
 
9. 
Will you be paid if you join this study? 
One gift card of $50.00 will be available for the household after completing the treatment and a $50.00 
gift card at the completion of the study if you are assigned to the household/sex partner treatment group. 
 
You may be required to provide your Social Security number to be paid.  If your payment for study 
participation exceeds $600 per year, this information must be reported to the Internal Revenue Service. 
 
10. 
Can you leave the study early? 
 You can agree to be in the study now and change your mind later. 
 If you wish to stop, please tell us right away. 
 Leaving this study early will not stop you from getting regular medical care.  
 If you leave the study early, Johns Hopkins may use or give out your health information that it 
already has if the information is needed for this study or any follow-up activities. 
 
11. 
Why might we take you out of the study early?  
You may be taken out of the study if: 
 Staying in the study would be harmful. 
 You need treatment not allowed in the study. 
 You fail to follow instructions. 
 You become pregnant. 
 The study is cancelled. 
 There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
already has if the information is needed for this study or any follow-up activities. 
 
12. 
How will your privacy be protected? 
Johns Hopkins has rules to protect information about you.  Federal and state laws also protect your 
privacy.  By signing this form you provide your permission, called your “authorization,” for the use and 
disclosure of information protected by the Privacy Rule. 
 
The research team working on the study will collect information about you.  This includes things learned 
from the procedures described in this consent form.  They may also collect other information including 
your name, address, date of birth, and information from your medical records.  This could include 
information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health 
problems. 
 
 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
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The research team will know your identity and that you are in the research study.  Other people at Johns 
Hopkins, particularly your doctors, may see or give out your information.    We make this information 
available to your doctors for your safety. 
 
People outside of Johns Hopkins may need to see your information for this study.  Examples include 
government groups (such as the Food and Drug Administration), safety monitors, other hospitals in the 
study and companies that sponsor the study. 
 
We cannot do this study without your permission to use and give out your information.  You do not have 
to give us this permission.  If you do not, then you may not join this study. 
 
We will use and disclose your information only as described in this form and in our Notice of Privacy 
Practices; however, people outside Hopkins who receive your information may not be covered by this 
promise.  We try to make sure that everyone who needs to see your information keeps it confidential – 
but we cannot guarantee this. 
 
The use and disclosure of your information has no time limit. You may cancel your permission to use 
and disclose your information at any time by notifying the Principal Investigator of this study by phone 
or in writing.  If you contact the Principal Investigator by phone, you must follow-up with a written 
request that includes the study number and your contact information.  The Principal Investigator’s name, 
address, phone and fax information are on page one of this consent form.   
 
If you do cancel your permission to use and disclose your information, your part in this study will end 
and no further information about you will be collected. Your cancellation would not affect information 
already collected in the study. 
 
13. 
Will the study require any of your other health care providers to share your health 
information with the researchers of this study? 
As a part of this study, the researchers may ask to see your health care records from your other 
healthcare providers. You will be asked to give us a list of other health care providers that you used.   
 
14. 
What treatment costs will be paid if you are injured in this study?  
Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being 
in the study.  However, medical care at Johns Hopkins is open to you as it is to all sick or injured people.   
 
 If you have health insurance:  The costs for any treatment or hospital care you receive as the result of 
a study-related injury will be billed to your health insurer. Any costs that are not paid for by your 
health insurer will be billed to you.  
 
 If you do not have health insurance:  You will be billed for the costs of any treatment or hospital care 
you receive as the result of a study-related injury. 
 
By signing this form you will not give up any rights you have to seek compensation for injury.  
 
15. 
What other things should you know about this research study? 
 
a. What is the Institutional Review Board (IRB) and how does it protect you?  
The Johns Hopkins Medicine IRB is made up of: 
 Doctors 
 Nurses 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
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 Ethicists 
 Non-scientists 
 and people from the local community.  
 
The IRB reviews human research studies. It protects the rights and welfare of the people taking part 
in those studies.  You may contact the IRB if you have questions about your rights as a participant or 
if you think you have not been treated fairly.  The IRB office number is 410-955-3008. You may 
also call this number for other questions, concerns or complaints about the research.  
 
b. What do you do if you have questions about the study?    
Call the principal investigator, Dr. Jason Farley at 410-502-7563. If you wish, you may contact the 
principal investigator by letter or by fax.  The address and fax number are on page one of this 
consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the 
IRB office at 410-955-3008.   
 
c. What should you do if you are injured or ill as a result of being in this study?  
If you think you are injured or ill because of this study, call Dr. Jason Farley at 410-502-7563 (office 
line) or 443-326-5759 (clinic line) during regular office hours.  
 
If you have an urgent medical problem related to your taking part in this study, call Dr. Jason 
Farley at 443-326-5759 during regular office hours and at 410-258-4506 (cell phone) after hours and 
on weekends.  
  
d. What happens to Data and Biospecimens that are collected in the study?  
Johns Hopkins our research partners work to cure diseases. The biospecimens and/or data collected 
from you during this study are important to both this study and to future research. 
 
If you join this study: 
 You will not own the data, or the tissue, blood, or other specimens given by you to the 
investigators for this research. 
 Both Johns Hopkins and any sponsor of this research may study your data and the tissue, blood 
or other specimens collected from you. 
 If data, tissue, blood, or other specimens are in a form that identifies you, Johns Hopkins may 
use them for future research only with your consent or IRB approval. 
 If data, tissue, blood or other specimens are in a form that we believe does not identify you, they 
may be shared with other academic medical centers, non-profit organizations, corporate sponsors 
and other commercial companies without your consent or IRB approval.  
 You will not own any product or idea created by the researchers working on this study. 
 You will not receive any financial benefit from the creation, use or sale of such a product or idea. 
 
16. 
Assent Statement 
This research study has been explained to my child in my presence in language my child can understand.  
He/she has been encouraged to ask questions about the study now and at any time in the future. 
 
 
 
 
 
 
 


 
Date: Aug. 05, 2014 
Principal Investigator: Jason E. Farley PhD, MPH, CRNP 
Application No.: NA_00079147 
 
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17. 
What does your signature on this consent form mean? 
 
Your signature on this form means that: 
 you understand the information given to you in this form  
 you accept the provisions in the form 
 you agree to join the study  
 
You will not give up any legal rights by signing this consent form.  
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
__________________________________________________________________________________________________________________________ 
Signature of Participant                                                          (Print Name)                                                       Date/Time 
                             
 
_________________________________________________________________________________________ 
Signature of Person Obtaining Consent                                     (Print Name)                                                     Date/Time 
                            
_________________________________________________________________________________________ 
Signature of Legally Authorized Representative (LAR) for ADULTS NOT                                                    
Date/Time    
CAPABLE of GIVING CONSENT (Persons from the following categories in order of 
priority may be a Legally Authorized Representative: Health Care Agent; Legal Guardian;  
Spouse; Adult child; Parent; Adult sibling; Friend or other relative)                                                                           
 
_____________________________________________________________________________________________________________ 
Relationship of LAR to Participant (indicate why the LAR is authorized                                                         
Date/Time 
 to act as a surrogate health care decision-maker under Maryland Law) 
 
_________________________________________________________________________________________ 
Signature of Parent                                                                                                                             
Date/Time 
 
__________________________________________________________________________________________________ 
Signature of Legally Authorized Representative (LAR) for CHILD RESEARCH PARTICIPANT               
Date/Time                         
 
___________________________________________________________________________________________________  
 
Description of LAR’s authority under Maryland Law to act as surrogate health care                                               Date/Time 
decision-maker for child research participant (for example, Legal Guardian, court-ordered representative) 
 
___________________________________________________________________________________________________ 
Signature of Parent #2 (required if DHHS 45 CFR 46.406 or   46.407/FDA 21 CFR 50.53 or 50.54 study)   
Date/Time 
 
__________________________________________________________________________________________ 
Signature of Child Participant (optional unless IRB required)                                                                         
 Date/Time 
 
__________________________________________________________________________________________ 
Signature of Witness to Consent Procedures (optional unless IRB or Sponsor required)                                 
 Date/Time 
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL 
INVESTIGATOR; A COPY MUST BE GIVEN TO THE PARTICIPANT;  
AND, IF YOU ARE NOT USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S 
MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED).   
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO 
OBTAIN THE CONSENT OF RESEARCH PARTICIPANTS.  IF THIS CONSENT FORM DOES NOT HAVE A 
JOHNS HOPKINS MEDICINE LOGO, DO NOT USE IT TO OBTAIN THE CONSENT OF RESEARCH 
PARTICIPANTS.