VS_092008AA_Section B-6 12 09

Evaluation of health communication messages for

Infertility Prevention Campaign

Supporting Statement

Part B

Project Officer

Allison Friedman, MS

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Division of Sexually Transmitted Disease Prevention

OD

Centers for Disease Control and Prevention

1600 Clifton Road NE, Mailstop E-44

Atlanta, GA 30333.

Voice: (404-639-8537)

Fax: (404-639-8622)

Email: alf8@cdc.gov

7/13/2009

Evaluation of health communication messages for

Infertility Prevention Campaign

Section

B. Collections of Information Employing Statistical Methods

1. Respondent Universe and Sampling Methods
Respondents for this research to increase screening and prevention of chlamydial infections are female adolescents and young women, ages 15-25 years. Convenience sampling will be used for this research.

Study Population

The study population will include four segments of females ages 15–25. CDC is targeting young women (15–25 year olds) because these individuals have the highest incidence of chlamydia. The four segments of participants are as follows:

• Females aged 15–17 who attend school (with parental consent)

• Females aged 15–17 who do not attend school (with parental consent)

• Females aged 18–25 who attend school

• Females aged 18–25 who are employed

Participant Inclusion Criteria

The target population will represent four segments of young women ages 15–25, reflecting a mix of socioeconomic (SES) levels. Participants will be screened to ensure they meet the following inclusion criteria:

Segment 1: 15–17 year-olds attending school

• Must be female ages 15–17

• Must currently be enrolled in school or be home-schooled

• Must identify themselves as Caucasian, African American, or Hispanic

• Must have sought reproductive health services (i.e. birth control or pelvic exam/Pap test) or had sexual intercourse

• Must be fluent in English and able to read at 7^th grade level

Segment 2: 15–17 year-olds not in school

• Must be female ages 15–17

• Must not be in school (if school is in session) or must not be intending to attend school in the upcoming school year (if summer). Can be working towards GED.

• Must identify themselves as Caucasian, African American, or Hispanic

• Must have sought reproductive health services or had sexual intercourse

• Must be fluent in English and able to read at 7^th grade level

Note: Participants in Segments 1 and 2 (15–17 year olds) will be recruited through a two-step process since they are minors. Parents/guardians will first be asked whether they give permission and verbal consent for their daughter to participate in the study. [Parental permission has been waived by IRB for mall intercepts and online surveys].

Segment 3: 18–25 year-olds who work

• Must be female ages 18–25

• Must work either full or part-time

• Must not be in school

• Must identify themselves as Caucasian, African American, or Hispanic

• Must have sought reproductive health services or had sexual intercourse

• Must be fluent in English and able to read at 7^th grade level

Segment 4: 18–25 year-olds who attend school

• Must be female ages 18–25

• Must be attending school either full or part-time

• Must identify themselves as Caucasian, African American, or Hispanic

• Must have sought reproductive health services or had sexual intercourse

• Must be fluent in English and able to read at 7^th grade level

Participant Exclusion Criteria

In order to be eligible to participate in the study, individuals in all audience segments) must satisfy the following, in addition to meeting the inclusion criteria outlined above:

• Must not have participated in a market research study in the past 6 months related to STDs or sexual/reproductive health.

• Must not work, volunteer, or study in field of sexual or reproductive health.

Note: CDC will not exclude nor actively target pregnant women if they qualify for participation.

2. Procedures for the Collection of Information

Eight hundred and eighty women will participate in this project. Over-recruitment, a standard industry practice for market research, will occur to account for potential no-shows and last-minute cancellations, however, no more than 880 females will be interviewed.

Focus Groups:

CDC will recruit subjects for focus groups using a professional recruitment company. The vendor will use its existing database to call two categories of adults from a range of SES levels/zip codes: adults with daughters (or guardians caring for female minors) in the targeted age range, and women in the adult target population (18–25 year-olds).

If the individual contacted is the parent or caregiver of a female minor in the appropriate age range (15–17) they will be screened using the Focus Group Screener for Parents of Minors (see Attachment 3C: Focus Group Screener for Parents of Minors) to see if the minor fits the criteria. If the minor fits the criteria, the parent will be asked to provide verbal consent for the daughter to be interviewed or participate in a focus group (see Attachment 4B: Parent/Guardian Informed verbal Consent).

Should the parent request specific information on the content of the screening or the interview, the recruiter will respond that “CDC is exploring ways to communicate with young women about measures they can take now to protect their health and prevent infertility in the future, including STD prevention and testing. The purpose of this study is to help CDC understand how to communicate with young women about these measures.”

If the parent requests to know actual elements of the screener, the recruiter will tell the parent the following: “For this study we are recruiting a mix of young women between the ages of 15 through 25 with different backgrounds and a range of experience. As is standard practice in research, we must protect their confidentiality, so we will not be sharing why they were or were not selected, nor will we be sharing what they tell us.”

If the parent gives consent, the minor will then be screened (see Attachment 3D: Focus Group Screener for Minors). If the minor is not immediately available to be screened, the recruiter will have the parent/guardian suggest a time or phone number for the daughter to be called back. If the daughter qualifies for the study, information will be provided about the date, time, and place for the focus group. The minor will be asked to give verbal assent before the scheduling of the interview (see Attachment 4A: Minor Informed Verbal Assent). During the verbal assent process, the minor will be told that the focus group session will be audio recorded, and observers may listen to the interview. Additionally, the minor will be advised that she will only use her first name during the focus group session, or she may choose to use a pseudonym. The requirement for written consent/assent for minor participants and their parents/guardians has been waived by IRB.

Adult participants will be screened by the recruitment company (see Attachment 3E: Focus Group Screener for Adult Women). If a candidate qualifies, information will be provided on date, time, and location of the focus group. The requirement for written consent for adult participants has been waived by IRB. Verbal consent will be confirmed (see Attachment 4C: Adult Informed Verbal Consent).

The recruitment company may leave messages for potential adult participants and for the potential minor participants who have received consent from their parent/caregiver. A message detailing the study will be left and a toll-free callback number will be provided. When individuals call the number, a recruiter will answer the telephone and the above recruitment procedures will be followed.

Intercept Surveys:

Respondents for intercept surveys will be recruited from four nationally diverse locations. Locations will be selected to facilitate recruitment of African American, Caucasian and Hispanic respondents, as well as a diversity of socio-economic status. (See Attachment 3B. Mall Intercept Screener & Moderator Guide: Female Adult & Minor (15-25 yr old)). A total of 100 female adolescents 15 to 17 years of age and 100 young women 18 to 25 years of age will be recruited. While random sampling will not be used, recruitment will take place at different times and locations within malls to facilitate greater representation.

Online Surveys:

Respondents to the online survey will be recruited from a nationally representative panel maintained by a vendor specializing in research for adolescents and young adults. As seen in Exhibit B.2.A, the panel provides an adequate sample size from which to recruit 100 adolescents between the ages of 15 and 17 and 400 young women 18 to 25 years.

Exhibit B.2.A. Sample Sizes of Nationally Representative Panel for Age Groups

Age Group	Approximate Number of Female Panel Participants
15-17 years	44,892
18-25 years	113,136

Recruitment will be from a panel rather than a random sample of all Internet users. However, randomization within the panel will be used in which every nth person meeting the criteria for race/ethnicity and school/working status will be recruited to participate in the survey, where n is a number between 5 and 100 chosen at random. For 15 to 17 year olds, a sample size of 100 at a 95% confidence level will allow a confidence interval of +/- 10 in the panel. Among young women 18 to 25 years in the panel, a sample size of 384, or approximately 400 respondents, at a 95 percent confidence level will guarantee a confidence interval +/- 5 in estimating a population proportion.

Since the response rate is estimated to be no lower than 40%, a total of 250 adolescents 15 to 17 years will be contacted for an expected sample size of 100, and a total of 1000 women 18 to 25 years will be contacted for an expected response of 400.

The screener and survey for the online survey is attached as 3F (Online Screener and Survey: Female Adult & Minors (15-25 yr old)).

3. Methods to Maximize Response Rates and Deal with Nonresponse

Exhibit B.3.A. displays the sample sizes for different research activities. Our focus groups, totaling 180 people, will be selected by professional recruiters using convenience samples. Two hundred young women will also be recruited by convenience samples to review print materials in mall intercepts. For Web sites, banners, or other online materials, a sample size of 500 young women will be recruited for surveys completed online.

Exhibit B.3.A: Sample Sizes by Research Activity

Audience Segment	Focus Group Participants	Mall Intercepts	Online Surveys	Total
15–17 yr old minors attending school	27	100	100	254
15–17 yr old minors not in school	27
18–25 yr old women who work	63	100	400	626
18–25 yr old women who attend school	63
Totals	180	200	500	880

The following procedures will be used to maximize cooperation and to achieve the desired participation rates:

• Recruitment through professional focus group facility recruitment firms.

• Reminder calls placed 1-2 days prior to the scheduled group.

• Payment of incentives to thank participants for their participating in the study.

• Over-recruiting will be done online however only 500 surveys will be accepted and analyzed.

4. Test of Procedures or Methods to be Undertaken

There are no new procedures or methods that will be included in this project.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Bonny Bloodgood, MA

Research and Health Communication Specialist Academy for Educational Development

(202) 884-8176

bbloodgood@aed.org

Derek Inokuchi, MHS

Research and Health Communication Specialist Academy for Educational Development

(202) 884-8652

dinokuchi@aed.org

Elyse Levine, PhD, MS

Senior Research and Health Communication Officer Academy for Educational Development

(202) 884-8913

elevine@aed.org

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