## Protocol Section
### Identification Module
**NCT ID:** NCT01197079

**Brief Title:** Utilization of Human Papillomavirus (HPV) Vaccine Among Young Men Who Have Sex With Men (MSM) and Parents of Boys (Aged 9 to 18 Years)

**Official Title:** Survey Study of the Awareness, Acceptance, and Barriers to Utilization of Human Papillomavirus (HPV) Vaccine Among Young Men Who Have Sex With Men (MSM) and Parents of Boys (Aged 9 to 18 Years)

#### Organization Study ID Info
**ID:** Merck IISP 37875
#### Organization
**Class:** OTHER
**Full Name:** Ann & Robert H Lurie Children's Hospital of Chicago
### Status Module
#### Completion Date
**Date:** 2011-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2011-07-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-07-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2011-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2010-08

**Status Verified Date:** 2011-07

#### Study First Post Date
**Date:** 2010-09-09
**Type:** ESTIMATED
**Study First Submit Date:** 2010-09-08
**Study First Submit QC Date:** 2010-09-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ann & Robert H Lurie Children's Hospital of Chicago

#### Responsible Party

**Old Name Title:** Tina Q. Tan, M.D.

**Old Organization:** Children's Memorial Hospital

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objectives of this study are:

1. to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged 9 to 18 years
2. to determine HPV vaccine acceptance and predictors of acceptance in a population of young MSM and in patients of boys ages 9 to 18 years
3. to develop strategies to overcome potential barriers to vaccination and improve vaccine access and utilization via development of targeted educational initiatives.

### Conditions Module

**Conditions:**

- Human Papillomavirus (HPV)

**Keywords:**

- HPV

- Vaccine

- Vaccine utilization

- Disease awareness

### Design Module

#### Design Info

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 800

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Young men (under 26 years of age) who have sex with men

**Intervention Names:**

- Other: Survey

**Label:** MSM

#### Arm Group 2

**Description:** Parents of Boys aged 9 to 18 years

**Intervention Names:**

- Other: Survey

**Label:** Parents

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MSM

- Parents

**Description:** Self administered anonymous survey

**Name:** Survey

**Type:** OTHER

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* MSM group - under age 26 years
* Parent group - parent of boy(s) ages 9 to 18 years

Exclusion Criteria:

* MSM group - previous receipt of HPV vaccine
* Parent group - previous receipt of HPV vaccine by male child

**Healthy Volunteers:** True

**Maximum Age:** 26 Years

**Minimum Age:** 9 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Young men who have sex with men (MSM) that obtain medical care from a Gay/Lesbian/Bisexual/Transgender community health clinic

Parents of boys aged 9 to 18 years who obtain their medical care from several public health clinics or who obtain their medical care from private pediatrician offices in Chicago

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ttan@northwestern.edu

**Name:** Tina Q Tan, MD

**Phone:** 773-880-4187

**Role:** CONTACT

**Contact 2:**

**Email:** mpgerbs@aol.com

**Name:** Melvin V Gerbie, MD

**Phone:** 312-951-0687

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Aleta Clark, MD

- **Phone:** 312-943-6964

- **Role:** CONTACT

***Contact 2:***

- **Name:** Aleta Clark, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Pediatric Private practice

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60610

**Location 2:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Marc Weissluth, MD

- **Phone:** 312-642-5515

- **Role:** CONTACT

***Contact 2:***

- **Name:** Marc Weissbluth, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Pediatric Private Practice

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60610

**Location 3:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Barbara Bayldon, MD

- **Phone:** 773-561-6649

- **Role:** CONTACT

***Contact 2:***

- **Name:** Barbara Bayldon, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Children's Memorial Hospital Uptown Clinic

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60640

**Location 4:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Bennett Kaye, MD

- **Phone:** 773-348-8300

- **Role:** CONTACT

***Contact 2:***

- **Name:** Bennett Kaye, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Pediatric Private Practice

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60657

**Location 5:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Kate Laslo, MD

- **Phone:** 312-666-5867

- **Role:** CONTACT

***Contact 2:***

- **Name:** Kate Laslo, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Erie Family Health Clinic

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Location 6:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** RGarofalo@childrensmemorial.org

- **Name:** Robert Garofalo, MD

- **Phone:** 773-388-8898

- **Role:** CONTACT

***Contact 2:***

- **Email:** jenniferl@howardbrown.org

- **Name:** Jennifer Leininger

- **Phone:** 773-388-8898

- **Role:** CONTACT

***Contact 3:***

- **Name:** Robert Garofalo, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Howard Brown Health Center

**State:** Illinois

**Status:** RECRUITING

**Location 7:**

**City:** Evanston

**Contacts:**

***Contact 1:***

- **Name:** Irwin Benuck, MD

- **Phone:** 847-869-4300

- **Role:** CONTACT

***Contact 2:***

- **Name:** Irwin Benuck, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Private pediatric practice

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60202

**Location 8:**

**City:** Evanston

**Contacts:**

***Contact 1:***

- **Name:** Ira Salafsky, MD

- **Phone:** 847-869-1070

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ira Salafsky, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Pediatric Private practice

**State:** Illinois

**Status:** NOT_YET_RECRUITING

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
