Supporting Statement - Family and Cultural Impact

Family and Cultural Impact on STD and HIV Risk among Latino and African-American Youth

Generic Information Collection request under 0920-0840

Section A: Supporting Statement

June 16, 2010

CONTACT

Leigh A. Willis, PhD, MPH

Centers for Disease Control and Prevention

Division of HIV/AIDS Prevention

Epidemiology Branch

Phone: 404.639.8447

Fax: 404.639.6127

Lwillis@cdc.gov

Table of Contents

Section

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of the Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less frequently

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

9. Explanation of Any Payment or Gift to Respondents

10. Assurance of Confidentiality Provided to Respondents

11. Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

14. Annualized Cost to the Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

17. Reason(s) Display of OMB Expiration Date is Inappropriate

18. Exceptions to Certification for Paperwork Reduction Act Submissions

20. Exhibits

21. Exhibit 12.A Estimated Annualized Burden Hours

22. Exhibit 12.B Estimated Annualized Burden Costs

23. Exhibit 14.A Estimated Cost to the Government

24. Exhibit 16.A Project Time Schedule

LIST OF ATTACHMENTS

Attachment 1 Data Collection Forms

1a. Focus Group Screener

1b. Survey Screener

1c. Focus Group Guide

1d. ACASI Survey Parents

1e. ACASI Survey Youth

Attachment 2 Consent forms

2a. Focus Group Consent

2b. Adult Survey Consent

2c. Adolescent Survey Assent

Attachment 3 Human Subjects Approvals

3a. Project Determination – CDC

3b. Local IRB Determination – CSUDH

Attachment 4 Recruitment materials

4a. Focus Group Recruitment Flyer

4b. Focus Group Recruitment Script

4c. Survey Recruitment Flyer

4d. Survey Recruitment Script

Minority HIV/AIDS Research Initiative (MARI) Project:

Family and Cultural Impact on STD and HIV Risk among Latino and African-American Youth

Supporting Statement

A. JUSTIFICATION

A.1 Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention proposes to conduct a formative research study that will provide vital information about how Latino and African-American parents and children communicate about sex and sexual matters which will aid the development of HIV/AIDS parent-child communication interventions for African-American and Latino families to add to the CDC portfolio of effective interventions for at-risk minority populations. The proposed study will use parent focus groups as well as Audio Computer Assisted Self Interviews completed by parents and children to determine effective communication strategies between parents and children about sex. The findings of this study can be used by other researchers in several ways: 1) to develop new methodologies of measuring parent-child communication, 2) to better understand mental models of parent-child communication about sex and 3) to create new, culturally-specific parent-child communication interventions specifically for African-American and Hispanic youth and their families.

African-American and Hispanic youth and young adults are disproportionately affected by the HIV epidemic. Adolescents also make up the fastest growing group of new HIV cases. Although prior research has identified parent-adolescent communication as important in reducing STD/HIV risk for youth and young adults, little is known about the specific strategies that parents use to talk to their children about sex. Previous studies have noted mixed results for parent-adolescent communication as a protective factor for adolescent risk behavior (Miller et al., 1998). Specifically, there is little known about strategies that African-American and Latino parents can and do use to talk to their children about sex. This formative study seeks to understand and explain the relationships among culture, parent-adolescent communication and STD/HIV risk among African-American and Latino youth. Upon completion of the data collection, this project will have unique data and will provide insight about the way Latino and African-American parents and children communicate with each other about sex and how that communication influences the HIV/STD risk behaviors of the child. Specifically, the study will provide information about the intersection of race, gender and culture and how they influence patterns of parent-child communication about sex and HIV/STD risk behaviors among African-American and Latino families. There is a dearth of research addressing parent-child communication among African-Americans and Latinos in the Western part of the United States. Once the information is collected and analyzed it will fill key gaps in research and can be easily translated into new, culturally relevant HIV prevention interventions targeting African-American and Hispanic youth to enhance CDC’s current portfolio of HIV prevention interventions.

A.1.2 Privacy Impact Assessment

The grantee, California State University (CSU) Dominguez Hills, will collect information in identifiable form (IIF). IIF will be collected from participants using focus groups interviews and computer assisted self-interviews by local study staff. Research staff at California State University Dominguez Hills will collect phone numbers to contact participants to take part in the focus groups or survey, signatures on informed consent documents, voices and names on audio tapes, and transcripts of audio-tapes. Other IIF collected include age, ethnicity, gender, and educational level. The main purpose of collecting this information is to characterize the participants in the study. Knowledge of participant characteristics will assist with the development of future interventions. Respondents’ names will not be used in data collected. ID numbers will be used in place of names. This information will be kept in a locked file cabinet, password protected computers and will be accessible only by the local project staff. Data collected from the Audio Computer Assisted Self Interview (ACASI) surveys will be stored on a separate password-protected computer in a password-protected file. The collected data is the property of The University of California, Dominguez Hills. After data analysis is completed, the University of California, Dominguez Hills, will destroy all participant IIF and data. No IIF will be transmitted to CDC.

A.1.3 Overview of the data collection system

The proposed cross-sectional study will be conducted in two phases aimed at describing strategies used by African American and Latino parents to discuss issues of sex with their children and to examine the influence of the family and culture on these strategies. Phase 1 is a qualitative study using focus groups of African-American and Latina mothers or female caregivers. Phase 2 is a quantitative study in which African-American and Latina mothers/female caregivers and their adolescent children will complete a computerized questionnaire.

In Phase 1, focus groups will help identify strategies that African-American and Latino parents use to communicate with their children about sex, the usefulness of those strategies and barriers to communicating about sex to their children (Attachment 1c). Forty-eight parents (24 African-Americans and 24 Latinos) will take part in the focus groups. Parents will be recruited and screened for eligibility and focus groups will be held until the sample sizes for African-Americans and Latinos are reached from local family facilities (Attachment 1a, Attachment 4a-b).

Potential participants for Phase 2 will be recruited at local Boys and Girls Clubs who have agreed to participate using identical methods from phase 1. They will be screened by phone (Attachment 1b, Attachment 4c-d). An estimated 400 family dyads will be recruited (one mother/female caregiver and one child per family), for a total of 800 participants. The large number of participants is necessary to test the concepts among an equal number of participants in each segment; African-American Mothers with Male (100) and Female (100) Children; Latino Mothers with Male (100) and Female (100) Children; African-American Male (100) and Female (100) Children; Latino Male (100) and Female (100) Children. Approximately 200 family dyads will be African-American and 200 will be Latino. In Phase 2, African-American and Latino mothers/female caregivers and their adolescent children will complete a computerized questionnaire (ACASI program) (Attachment 1d and 1e). Separate analyses will be carried out for the parent and child samples. The focus of this project is to explore the relationship of culture and communication strategies among parents and children and also how these communication strategies influence HIV/STD risk of children in order to develop materials and interventions to promote parent-child communication and HIV/STD prevention among children.

If the participant is not able to complete the questionnaire on his or her own due to literacy or visual impairment, the questionnaire will be administered by a trained research assistant via face-to-face interview or over the phone.

A.1.4 Items of Information to be collected

The focus groups will be comprised of approximately 8 participants each. Focus groups will be conducted and are expected to last between 60 and 90 minutes to accommodate the participants. The focus groups will include questions about:

1. current strategies used to talk to their children about sex,

2. the utility of suggested strategies (from public service announcements) on talking with children about sex

3. barriers and enabling factors for talking with children about sex (See Attachment 1c).

Each parent and child participant will complete a computer-based questionnaire (ACASI program) with items to assess:

• Demographics

• Psychosocial factors (culture, ethnicity)

• Parent-adolescent communication

• STD/HIV risk among adolescents. The questionnaire will include items to assess content, context, barriers, and facilitators of parent-adolescent communication about sex (Attachment 1d and 1e).

A.1.5 Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age

This information collection does not involve websites or website content directed at children under 13 years of age.

A.2. Purpose and Use of Information Collection

The purpose of the “Minority HIV/AIDS Research Initiative (MARI) Research Project: Family and Cultural Impact on STD and HIV Risk among Latino and African-American Youth” project is to conduct formative research for developing new tools and methodologies regarding strategies African-American and Latino parents use to communicate with their children about sex. The information collected from this study will be used to develop innovative and culturally relevant intervention materials targeting STD and HIV risk reduction through parent-adolescent communication to add to CDC’s portfolio of HIV prevention materials. The types of data collection activities used are the following:

A.2.1 Qualitative interviewing for surveillance, research and intervention methods and material development

Qualitative interviewing will be used with volunteer respondents (African-American and Latino parents) to identify intervention content and delivery regarding key concepts and strategies they use when communicating about sex with their children. Results of the focus groups and qualitative interviews will be used to develop the most appropriate and successful research methods, interventions, data collection instruments, messages, products, and campaigns for current and future projects.

A.2.5 Field Testing of New methodologies and Materials

The purpose of this data collection is to conduct field tests of new methods and data collection instruments. The objective of such testing is to evaluate the feasibility of the “new” strategies in CDC-funded projects. Specifically, the ACASI method and the questionnaire the investigator has developed will be tested for the first time with African-American and Latino Families in California.

A.2.6 Testing of Communication Mental Models

The purpose of this data collection is to develop and test mental modeling methodologies. The information that will be collected in the focus groups and the ACASI interviews will be used to revise, augment or finalize communication campaign platforms and systems. Specifically, this data collection seeks to determine communication mental models that parents use to communicate with their child about sex. By understanding mental models, one can also take into account in message design decision points at-risk individuals (or groups) undergo when they move between internal-based reality (e.g., intra-personal attitudes, knowledge, values, perceived stigma, racism, discrimination, sexism, beliefs and skills) and external-based, actionable reality (e.g., outward behaviors, environmental constraints, health inequity).

A.3. Use of Improved Information Technology and Burden Reduction

In Phase 1, focus groups will be recorded on digital recorders. Each focus group will be transcribed professionally from the digital recording into a Microsoft Word file.

In Phase 2, data will be collected via audio-computer assisted self interview (ACASI). Survey questions will be answered via computer using the Questionnaire Development System (QDS; NOVA Research, Bethesda, Maryland) and downloaded onto memory stick (USB: encrypted) for transfer of completed interview data to CSU Dominguez Hills by the interview facilitator within 72 hours per protocol.

A.4. Efforts to Identify Duplication and Use of Similar Information

NCHHSTP has verified that there are no other federal collections that duplicate the data collection tools and methods included in this request.

A.5. Impact on Small Businesses and Other Small Entities

No small businesses will be involved in this data collection.

A.6. Consequences of Collecting the Information Less Frequently

The activities involve a one-time collection of data. There are no legal obstacles to reducing the burden.

A.7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agencies

A Federal Register Notice for the generic clearance 0920-0840 was published on March 11, 2009.

A.9. Explanation of Any Payment or Gift to Respondents

Project participants will be offered cash tokens of appreciation that will not exceed $40 per person per hour.

In Phase 1, each participant will be provided a $50 token of appreciation for taking part in the 90-minute focus group. This token will help recruit participants who are hard to reach.

In Phase 2, each family dyad will be given a $50 token of appreciation for completing the 90-minute ACASI survey; which will consist of $30 for the parent and $20 for the adolescent. Based on the subject matter experts’ experience, the token is needed to encourage participation. Maximizing the numbers of participants will enhance the study quality. The maximum token for parents who participate in both phases is $80 (for 3 hours total, including 90-minute focus group and 90-minute survey), and the maximum token for the adolescents is $20 (for 90 minute survey).

A.10. Assurance of Confidentiality Provided to Respondents

After the focus group or survey is completed, all contact information of the participants will be destroyed. After the audio tapes have been transcribed, they will be deleted from the computer and erased from the recorder. Each name on the audio tapes will be changed to a general name, such as participant #1, #2, etc… in the typed transcripts.

Survey data collected with the ACASI module are initially stored to the laptop computer. After each interview, data will be compiled with data that has already been collected. Compiled data will be backed up on a password-protected server. Compiled data will also be backed up on an encrypted USB memory stick. Data will be purged from the transportation memory sticks and the laptop computers on a monthly basis.

Respondents will be told that no information in identifiable form will be available to or shared with the CDC. Analysis of the dataset will take place at California State University Dominguez Hills. The information that will be collected in this project will be owned by the California State University Dominguez Hills (CSUDH). CSUDH will be the only entity with access to the IIF and information collected. If any data is shared with CDC, it will be de-identified and transferred securely to CDC via the Secure Data Network’s (SDN) file transfer service.

Prior to participating in any phase of the study, the parents and teens will be required to give informed consent and assent. Written consent and assent will be obtained when the participants arrive at the study site (California State University, Dominguez Hills). For Phase 2, the mother will sign the consent form first (Attachment 2b). The mother’s form will consent her and her child into the study. The consent form will be read aloud to the mother. After the mother has signed her consent form to take part in the study, the assent form for her child to take part in the study will be read aloud (Attachment 2c). After the consent and assent forms have been read, the mother and child will be allowed to ask as many questions as needed to ensure s/he understands what s/he will be asked to do as part of the study prior to signing the consent and assent forms, respectively. All consent and assent forms with participant names and signatures will be kept in a locked file cabinet in a locked room, separate from the data files. They will be taken to this location promptly after they have been collected. Adult and child participants will be provided with copies of their consent and assent forms.

A.11. Justification for Sensitive Questions

The study asks parent and adolescent participants questions of a sensitive nature. Questions concerning sexual behavior , substance use will be asked of adolescent participants. These questions are necessary to assess levels of these STD/HIV risk behaviors in order to identify intervention content and delivery regarding key concepts and strategies parents use when communicating about sex with their children. The questions used in this project are from the Youth Risk Behavior Surveillance System, which is conducted by the CDC every two years. Similar to data collected in the YRBSS, the questions refer to past behaviors rather than current behaviors so there are no questions which would mandate parents knowledge. Specifically, the questions regarding sexual activity are similar for standard questions asked at STI examinations, which according to California law do not require parental consent for minors 12 and over. The informed consent will inform parents that their children will be asked these questions and that the researcher does not plan to share this information with the parent. If this makes the parent uncomfortable, they have the option of refusing to participate in the study.

All participants are asked about their racial and ethnic identity in order to assess how these factors affect their communication about sex. The results will be used to develop interventions targeted toward African-American and Latino parents and youth.

Questions concerning acculturation, parental communication about sex, and family functioning are necessary to assess how these factors influence parent talking strategies and youth risk behaviors.

In no case will a participant’s social security number be obtained by agency staff.

A.12. Estimates of Annualized Burden Hours and Costs

A.12.A. Estimated Annualized Burden Hours

Two types of respondents will participate in the study. One type consists of African-American and Latina mothers or female caregivers, and the other consists of their adolescent children, aged 12-15 years old. In order to ensure 48 adult parents in Phase 1, we will administer a 7-minute screener to 58 parents. Forty-eight parents will participate in the 90-minute focus group. For Phase 2, 480 family dyads will be screened (7 minutes) to enroll 400 mother/child pairs. A total of 400 family dyads will complete the 90-minute survey.

Exhibit A.12.A Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	Number of Responses Per Respondent	Average Burden Per Response (in Hours)	Total Burden Hours
General Public-Parents	Focus Group Screener	58	1	7/60	7
General Public-Parents	Survey Screener	480	1	7/60	56
General Public-Parents	Focus Group Guide	48	1	1.5	72
General Public-Parents	ACASI Survey - Parents	400	1	1.5	600
General Public-Youth	ACASI Survey – Youth	400	1	1.5	600
Total					1335

A.12.B. Estimated Annualized Burden Costs

The annualized costs to the respondents are described in Exhibit A.12.B. The United States Department of Labor Statistics May, 2005. (http://www.bls.gov/oes/current/oes_nat.htm was used to estimate the hourly wage rate for the general public for the purpose of this generic request. The figure of $20.23 per hour was used as an estimate of average hourly wage for parents and the figure of $5.85 was used as an estimate of average hourly wage for teens across the country. Thus, the total anticipated annual cost to participants for collection of information in this project will be $18,379.

Exhibit A.12.B: Estimated Annualized Burden Costs

Type of Respondent (Form Name)	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
General Public-Parents (Focus Group Screener)	7	$20.23	$142
General Public-Parents (Survey Screener)	56	$20.23	$1,133
General Public-parents (Focus Group Guide)	72	$20.23	$1,456
General Public- Parents (ACASI Survey Parents)	600	$20.23	$12,138
General Public-Youth (ACASI Survey Youth)	600	$5.85	$3,510
Total	1335		$18,379

A.13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no costs to respondents or record keepers.

A.14. Annualized Cost to the Government

This activity will involve participation of one CDC project officer who will assist with project design, obtaining IRB and OMB approvals, and providing project oversight. A data manager is involved to provide support and maintenance for the ACASI QDS program that will be used during data collection and analysis. Travel expenses include two site visits.

Exhibit A.14: Estimates of Annualized Cost to the Government

Expense Type	Expense Explanation	Annual Costs (dollars)
Direct Costs to the Federal Government	CDC Project Officer (GS-13,0.25 FTE)	$22,087
	CDC Travel for Site Visits (2 trips)	$4,500
	Subtotal, Direct Costs	$26,587
Cooperative Agreement or Contract Costs	Cooperative Agreement to the University of California, Dominguez Hills	$259,301
	Contractor CDC Data Manager/QDS Support (GS-9/10 equivalent; 0.25 FTE)	$13,500
	Subtotal, Cooperative Agreement or Contract Costs	$272,801
	TOTAL COST TO THE GOVERNMENT	$299,388

A.15.Explanation for Program Changes or Adjustments

Not applicable – request is for a sub-collection under a generic approval.

A.16. Plans for Tabulation and Publication and Project Time Schedule

Data collection will be completed during the first year after OMB approval is granted. Phase 1 data collection will be completed by 5 months after approval. Phase 2 of data collection will be completed by 10 months after approval. Data analysis will be completed by 11 months after approval. Dissemination of results will begin 12 months after OMB approval.

Exhibit A.16: Project Time Schedule

Activity	Time Schedule
Recruit and enroll for focus groups	1-2 months after OMB approval
Conduct focus groups	2-5 months after OMB approval
Analyze focus groups	5-8 months after OMB approval
Recruit and enroll for surveys	9-10 months after OMB approval
Analysis of survey results	10-11 months after OMB approval
Share findings with all stakeholders	12 months after OMB approval

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate

OMB Expiration Date will be displayed.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

B. Collection of Information Employing Statistical Methods

This information collection request does not employ statistical methods. The following is a description of data collection procedures.

B.1. Respondent Universe and Sampling Methods

Families will be recruited from Boys and Girls Club in Long Beach, California. Criteria for inclusion in the both phases of the study include:

• African American or Latino.

• Female

• Biological or custodial care taker of a child ages of 12 - 15 years old who participates in a local family facility (Boys and Girls Clubs).

B.2. Procedures for the Collection of Information

B.2.1. Recruitment

The participants will be recruited through announcements and flyers sent home with youth at all 7 Boys and Girls Clubs in Long Beach, California (Attachments 4a and 5d). The research assistants will make announcements about the study and distribute the flyers within these group settings.

B.2.2. Screening and Scheduling Procedures

For each phase of the study the potential participants will be given a number to call to be screened for study participation (Attachments 4b, 4d) for the focus groups and ACASI surveys. Efforts will be made to enroll about half of participants with female children and half with male children for Phase 2. If potential participants are screened as eligible, they will be scheduled for the focus groups(Phase 1)or ACASI surveys(Phase 2) based on their schedules.

B.2.3. Data Collection Methods

a) Focus groups (Qualitative Interviewing)

• 48 female caregivers (24 Latina and 24 African-American women) will be selected to be asked to participate in the focus groups. Focus groups will be scheduled at times convenient to accommodate the maximum number of study participants. Study staff will work with Boys and Girls Club staff to co-ordinate dates, times and locations for each focus group. When respondents arrive, they will be greeted by project staff and directed to the focus group room. Prior to the start of the focus groups, facilitators will read the informed consent and ask potential participants to sign the form if she agrees to participate. Before beginning the recording, the moderator will ask if the participants agree to be recorded. Those that do not wish to be recorded will be excused from the group.

c) Surveys including CAPI/CASI, ACASI, web-based surveys

• In Phase 2, a total of 800 participants, 200 Latino and 200 African-American parent child dyads, will be surveyed separately by ACASI (Attachment 1d-e). The surveys will be conducted at the Boys and Girls Club or at the participant’s home. Care will be taken to ensure that the parents and children will not be able to view each others’ responses. The ACASI survey program will be audible by headphones and visible on the computer screen.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

The study staff will use multiple strategies to maximize response rates and to decrease nonresponse. In Phase 1, the study staff will schedule focus groups at days and times when a maximum number of respondents are available. When attempting to schedule focus groups respondents will be asked for two weekend dates when they will be available to participate in the groups. Once the groups are scheduled participants will receive reminder phone calls from study staff to remind them to attend. In Phase 2, identical methods will be used to maximize response and decrease non-response for the parent and child. Participants will have two potential dates for completing the ACASI surveys as well as having the option of completing them at the Boys and Girls Club or in the comfort of their own home.

B.4. Tests of Procedures or Methods to be Undertaken

This submission is a request for authorization to conduct tests of procedures and methodologies typical in methods and instrument development.

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

No other individuals were consulted on the statistical aspects or analysis of data from this sub-collection.

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