Form 1 Survey

HIGHLY IMPACTED POPULATION SURVEY

Attachment C: Screeners and Survey Questionnaire

Please note: This instrument begins with screeners, with questions tailored to each of the following populations/modes.

• CATI - Listed General Population

• CATI - Listed African Americans and Hispanic/Latinos

• CATI - Unlisted Eligible Households Returning Card

• Online Survey

• Incoming CATI Interviews

The screeners are followed by the survey questionnaire, with questions asked of all eligible respondents identified by the screeners.

NHVREI Highly Impacted Population (HIP) Survey

Public reporting burden for this collection of information is estimated to average 20 minutes per response. This time includes the length of time allotted for the survey questions. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN; PRA (0925-XXXX). Do not return the completed form to this address.

HIP SCREENER

– CATI-Listed General Population Sample ONLY–

Introduction
Hello. My name is _______. I am calling about the National Institutes of Health study we recently sent you information about. This is a health survey. We are not selling anything or asking for donations.
RANDOM SELECTION/GENDER QUOTA
S1.	record gender of adult informant (note: recording of adult informant gender is for possible later use to ensure proper gender balance if it becomes necessary.)
		male 1 female 2
S2.	So that all types of people will be represented in our survey, I need to know how many adults live here. How many persons age 18 or older currently live in this household, including yourself? (if necessary, explain that selection is done quickly and does not involve getting names and other personal info)
		one 1  go to S3 two 2  go to S4a/b three or more 3  go to S5a/b no adults in household 4  terminate refused ref  if another adult available, ask for them, repeat intro and go to S2; otherwise, thank and terminate
	if S2 = 1, ask:
	S3.	Is that you?
		yes, speaking with adult 1  go to S6 not speaking with adult 2  ask to speak to adult, then return to intro no, not available now 3  get and record first/name initials and arrange call back; get alternative phone number as needed refused ref  terminate
	if S2 = 2 and cati randomly selects respondent, ask:
	S4a.	We would like to continue the interview with you.
		yes, continue 1  go to S6 arrange callback 2  get and record first/name initials and arrange call back; get alternative phone number as needed refused ref  terminate
	if S2 = 2 and cati randomly selects other adult, ask:
	S4b.	We would like to speak to the other adult who lives in your household. May I please speak with that person?
		yes, and comes to phone 1  go to S6 no, not available now 2  get and record first/name initials and arrange call back; get alternative phone number as needed no, refused ref  terminate
	if S2 = 3 or more and cati randomly selects respondent, ask:
	S5a.	We would like to continue the interview with you.
		continue 1  go to S6 not available now 2  get and record first/name initials and arrange call back; get alternative phone number as needed refused ref  terminate
	if S2 = 3 or more and cati does not select respondent, say:
	S5b.	In order to randomly select one of the other adults for the survey, please think of the adult besides yourself who has had the most recent birthday. May I please speak with that person?
		yes, and comes to phone 1  go to S6 no, not available now 2  get and record first/name initials and arrange call back; get alternative phone number as needed no, refused ref  terminate
RANDOM SELECTION/GENDER QUOTA
S6.	Just to confirm…you are over 18 and live in the household. Is that correct?
		yes 1  continue to informed consent no 2  terminate refused ref  terminate

HIP SCREENER

• CATI-Listed –

• African-American, Black and Hispanic/Latino Sample ONLY –

Introduction
Hello. My name is _______. I am calling about the National Institutes of Health study we recently sent you information about. This is a health survey. We are not selling anything or asking for donations.
Getting an Adult Informant
S1.	May I please speak with someone 18 or older who lives in the household?
		resp. is 18 or older 1  continue to S2 resp. will get someone who is 2 confirm age, repeat intro, go to S2 no one 18+ available now 3 schedule call back no one 18+ living here 4 terminate and code hh as age-ineligible
RANDOM SELECTION/GENDER QUOTA
S2.	record gender of adult informant (note: recording of adult informant gender is for possible later use to ensure proper gender balance if it becomes necessary.)
		male 1 female 2
S3.	S }continue o that all types of people will be represented in our survey, I need to know how many adults live here. How many persons age 18 or older currently live in this household, including yourself? (if necessary, explain that selection is done quickly and does not involve getting names and other personal info)
		one 1 two 2 three or more 3 refused ref  if another adult available, ask for them, repeat intro and go to S2; otherwise, thank and terminate
S4.	And how many of these have an African American, Black, Latino, or Hispanic background? (if necessary, say:) In order to make sure we get the opinions of all kinds of people living in the United States, it is important for this survey that we speak to African American, Black and Hispanic/Latino adults.
		one 1  go to S5 two 2  go to S6a/b three or more 3  go to S7a/b no african american, black or Hispanic/Latino adults in hh 4  terminate refused ref  if another adult available, ask for them, repeat intro and go to S2; otherwise, thank and terminate
	if S4 = 1, ask:
	S5.	Is that you?
		yes, speaking with the adult 1  go to S8 not speaking with the adult 2  ask to speak to adult, then return to intro no, not available now 3  get and record first/name initials and arrange call back; get alternative phone number as needed refused ref  terminate
	if S4 = 2 and cati randomly selects respondent, ask:
	S6a.	We would like to continue the interview with you.
		yes, continue 1  go to S8 arrange callback 2  get and record first/name initials and arrange call back; get alternative phone number as needed refused ref  terminate
	if S4 = 2 and cati randomly selects other adult, ask:
	S6b.	We would like to speak to that other adult who lives in your household. May I please speak with that person? (if necessary, say:) I would like to speak to the other African American, Black, Hispanic or Latino adult who lives here.
		yes, and comes to phone 1  go to S8 no, not available now 2  get and record first/name initials and arrange call back; get alternative phone number as needed no, refused ref  terminate
	if S4 = 3 or more and cati randomly selects respondent, ask:
	S7a.	We would like to continue the interview with you.
		continue 1  go to S8 not available now 2  get and record first/name initials and arrange call back; get alternative phone number as needed refused ref  terminate
	if S4 = 3 or more and cati does not select respondent, say:
	S7b.	In order to randomly select one of the other adults for the survey, please think of the other African American, Black and Hispanic/Latino adults in your household, besides yourself. May I please speak with the African American, Black, or Hispanic/Latino adult who has had the most recent birthday?
		yes, and comes to phone 1  go to S8 no, not available now 2  get and record first/name initials and arrange call back; get alternative phone number as needed no, refused ref  terminate
CONFIRMATION OF ELIGIBILITY
S8.	Just to confirm…you are over 18 and live in the household. Is that correct?
		yes 1  continue no 2  terminate refused ref  terminate
S9.	What is your Ethnicity?
		hispanic or latino 1  continue to informed consent not hispanic or latino 2  continue refused ref  terminate
S10.	What is your Race? (answer may be a multiple)
		american indian or alaska native 1 terminate asian 2 terminate black or african american 3 continue to informed consent native hawaiian or other pacific islander 4 terminate white 5 terminate

HIP SCREENER

• CATI-Unlisted Households ONLY: –

• General Population, African-American and Hispanic/Latino Subsamples –

CONTACTING WHO RETURNED THE CARD

S1.

Hello. May I please speak with (insert first name from sample record)?

card returner is on phone 1  go to intro

card returner is coming to phone 2  wait, then go to intro

card returner not available 3  schedule call back

Introduction

Hello. My name is _______. I am calling about the National Institutes of Health study that you expressed interest in participating in. As you know, this is a health survey. We are not selling anything or asking for donations.

CONFIRMATION OF ELIGIBILITY

S2.

Are you over 18?

18 or over 1continue S9 under 18 2  terminate refused ref  terminate

HIP SCREENER

– Online ONLY–

Introduction
Welcome to the National Institutes of Health survey! This is a health survey. We are not selling anything or asking for donations. We appreciate your interest in the study.
ACCESS CODE
S1.	Before we get started, please enter the access code you got in the mail: ____________. (code will reveal which sample they are from)
S2.	Do you currently reside at the same address where you got the mailing about this study?
		yes, i do 1  continue to S3 no, I moved 2  terminate
S3.	Are you over 18?
		resp. is 18 or older 1  continue to S4 resp. is under 18 2  terminate
S4.	What is your gender?
		male 1 female 2
S5.	What is your ethnicity?
		hispanic or latino 1 not hispanic or latino 2
S6.	What is your race? (answer may be a multiple)
		american indian or alaska native 1 asian 2 black or african american 3 native hawaiian or other pacific islander 4 white 5
if Hispanic/Latinosample and S5 = no, thank & terminate. if african american sample and S5 = no and S6 ≠ black or african american, thank & terminate.

HIP SCREENER

– Incoming CATI Interview ONLY–

Introduction
Hello. Welcome to the National Institutes of Health survey. As you know, this is a health survey. We are not selling anything or asking for donations. We appreciate your interest in the study.
ACCESS CODE
S1.	Before we get started, please tell me the number from the card you got in the mail: ____________. (code will reveal which sample they are from)
S2.	Do you currently reside at the same address where you got the mailing about this study?
		yes, i do 1  continue to S3 no, I moved 2  terminate
S3.	Are you over 18?
		resp. is 18 or older 1  continue to S4 resp. is under 18 2  terminate
S4.	What is your gender?
		male 1 female 2
S5.	What is your ethnicity?
		hispanic or latino 1 not hispanic or latino 2
S6.	What is your race? (answer may be a multiple)
		american indian or alaska native 1 asian 2 black or african american 3 native hawaiian or other pacific islander 4 white 5
if Hispanic/Latinosample and S5 = no, thank & terminate. if african american sample and S5 = no and S6 ≠ black or african american, thank & terminate.

INFORMED CONSENT (For all completing the screener)

The National Institutes of Health (NIH) is conducting a national study. This study is on attitudes about research to prevent the spread of Human Immunodeficiency Virus (HIV). HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Your participation in this study will help NIH develop related educational programs. We will provide you with $20 upon completion of the survey.

Completing the survey should take about 20 – 30 minutes. We want your opinion, so there are no right or wrong answers to the questions. There are two questions about HIV status and sexual orientation. Some people might consider these questions to be personal. Your honest answers to these and all survey questions are greatly appreciated.

• Your identity will be protected. Your answers will be assigned a confidential ID number so that your name will not be directly linked to them

• Your name will be stored separate from your answers and only a few people directly involved in the study will have access to it. Data files will be stored securely so that outsiders cannot see them. After the study is complete your name and contact information will be destroyed.

• Your answers will be put together with the responses of other participants and analyzed as a group. No one will be identified in reports or publications from this study.

Do you have any questions?

Your participation is voluntary. You can choose to not answer questions and stop your participation at any time. We believe that your participation in the survey has very low risk of harm to you.

If you have questions about this study or your participation, please contact _____________ by email at ___________ or by phone at _____________.

MONITORING

For quality assurance purposes, this call may be monitored by my supervisor.

1. What is your year of birth? __ __ __ __

Researchers are now working to develop three new methods for preventing HIV. They will be made available once they have been proven to be safe and effective.

One new method is an HIV Vaccine.

An HIV Vaccine would trigger the body’s defenses to fight HIV infection.

2. Have you ever read or heard anything about a vaccine to prevent HIV?

	No
	Yes
	[IF YES], About how long ago?
		More than 12 months ago.
		Less than 12 months ago.

The second method, Microbicides, could come in different forms such as gels, foams, creams, or sponges. They would be put into the vagina or rectum to prevent HIV infection.

3. Have you ever read or heard anything about Microbicides?

	No
	Yes
	[IF YES], About how long ago?
		More than 12 months ago.
		Less than 12 months ago.

The third method is Pre-exposure prophylaxis, or PrEP. Prophylaxis means “prevention.” PrEP would involve people who do not have HIV taking anti-viral medicines to protect against getting HIV. Now, these anti-viral medicines are usually used to treat people already infected with HIV.

4. Have you ever read or heard anything about PrEP?

	No
	Yes
	[IF YES], About how long ago?
		More than 12 months ago.
		Less than 12 months ago.

5. How concerned are you about getting HIV? Are you…

   Not at All Concerned?	Only A Little Bit Concerned?	Somewhat Concerted?	Very Concerned?	Don’t Know	Not Applicable

6. Thinking about the people who are closest to you, how concerned are you about their getting HIV? Are you…

   Not at All Concerned?	Only A Little Bit Concerned?	Somewhat Concerned?	Very Concerned?	Don’t Know

7. What is your overall level of concern about people getting HIV in any of the communities to which you belong? Are you…?

   Not at All Concerned?	Only A Little Bit Concerned?	Somewhat Concerned?	Very Concerned?	Don’t Know

8. I’m going to read two statements, and I’d like you to tell me whether you Strongly Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat Agree, or Strongly Agree with the statements.

	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
New methods to prevent HIV infection are needed. Do you…
Currently, many people have little control over protecting themselves from HIV. Do you…

Developing new methods to prevent HIV infections requires clinical trials. Clinical trials are research studies that test medicines with human volunteers to find out if the medicines are safe and work well, before they are made available to the public.

9. How willing would you be to engage in the following activities in the next year? Would you be Not At All Willing, Only A Little Bit Willing, Somewhat Willing, or Very Willing to….?

   	Not at All Willing?	Only A Little Bit Willing?	Somewhat Willing?	Very Willing?	Don’t Know
   Seek out information about new HIV prevention methods? Are you…
   Would you consider participating in a clinical trial to test a new HIV prevention method (assuming it was nearby and you were eligible)? Are you…
   Would you start up a conversation with people about the importance of HIV prevention trials? Are you…

10. How likely would you be to talk positively about HIV prevention clinical trials to others?

Would It be likely that you would talk positively about…

	Not At All Likely?	Only A Little Bit Likely?	Somewhat Likely?	Very Likely?	Don’t Know
HIV Vaccine Trial Vaccines would trigger the body’s defenses to fight HIV. Would you be…
Microbicide Trial These would be put into the vagina or rectum to prevent HIV infection. Would you be…
PrEP Trial PrEP is anti-viral medicines that would be taken to prevent HIV infection. Would you be…

11. Do you have concerns about participating in clinical trials for new methods of preventing HIV? If yes, what are your concerns?

         

12. Please tell me whether you Strongly Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat Agree, or Strongly Agree with the following statements about clinical trials for HIV prevention.

    	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
    Clinical trial participants are well protected by research procedures. Do you…
    I am very concerned that people might get sick from serious side effects if they participate in a clinical trial. Do you…
    I might consider participating in an HIV prevention clinical trial if I had more information. Do you…
    Only people who are at high risk for HIV are needed for prevention clinical trials. Do you…
    People are encouraged to have unprotected sex as part of clinical trials for new HIV prevention methods. Do you…
    Drug companies have delayed vaccine research because they make money from people with HIV. Do you…

13. How much do you agree or disagree with each of the following statements about VACCINES to prevent HIV infection?

Vaccines would trigger the body’s defenses to fight HIV.

	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
It seems likely that scientists will develop a vaccine to prevent HIV in my lifetime. Do you…
An HIV vaccine exists but is being withheld because of discrimination against certain groups. Do you…
Vaccines are safe for the public to use once they have been approved by the U.S. Food and Drug Administration (FDA). Do you…
If people were protected against HIV infection by a vaccine, casual sex and illegal drug use would increase. Do you…
People may contract HIV from a vaccine being tested in a clinical trial. Do you…

14. How much do you agree or disagree with each of the following statements about MICROBICIDES?

Remember that microbicides would be put into the vagina or rectum to prevent HIV infection.

	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
Microbicides are a promising method for preventing HIV. Do you…
People may get HIV as a result of using a microbicide in a clinical trial. Do you…
I would need more information about microbicides before considering participating in a clinical trial. Do you…

15. How much do you agree or disagree with each of the following statements about PrEP?

Remember that PrEP would involve taking anti-viral medicines to prevent HIV infection.

	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
a. Using anti-viral medicines for PrEP may lead to the virus becoming drug resistant. Do you…
b. PrEP is appropriate for people who are at low risk of HIV infection. Do you…
c. It would be great if people could take anti-viral medicines to protect themselves from HIV. Do you…
d. I would need more information about PrEP before considering participating in a clinical trial. Do you…

16. How much do you agree or disagree with the following statements.

	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
Preventing HIV doesn’t concern me personally. Do you…
[IF AGREE OR STRONGLY AGREE ONLY]
i. How much does this keep you from talking positively about prevention clinical trials?		Not at all	Only A Little Bit	Somewhat	A Lot	Don’t Know

	Strongly Disagree?	Somewhat Disagree?	Neither Agree Nor Disagree?	Somewhat Agree?	Strongly Agree?	Don’t Know
b. Drug companies make money at the expense of volunteers in clinical trials. Do you …
[IF AGREE OR STRONGLY AGREE ONLY]
i. How much does this keep you from talking talking positively about prevention clinical trials?		Not at all	Only A Little Bit	Somewhat	A Lot	Don’t Know

	Strongly Disagree	Somewhat Disagree	Neither Agree Nor Disagree	Somewhat Agree		Strongly Agree			Don’t Know
c. People who participate in clinical trials for new HIV prevention methods might be considered gay, HIV positive, or to have many sexual partners. Do you…
IF AGREE OR STRONGLY AGREE ONLY]
i. How much does this keep you from talking positively about prevention clinical trials?		Not at all	Only A Little Bit	Somewhat	A Lot		Don’t Know

	Strongly Disagree	Somewhat Disagree	Neither Agree Nor Disagree	Somewhat Agree	Strongly Agree			Don’t Know
d. For many people, participating in a clinical trial is difficult because it takes too much time and travel costs too much. Do you…
[IF AGREE OR STRONGLY AGREE ONLY
i. How much does this keep you from talking positively about prevention clinical trials?		Not at all	Only A Little Bit	Somewhat	A Lot	Don’t Know

17. If proven safe and effective, how likely would you be to use any of the following methods for preventing HIV? Would you be Not at All Likely, Only A Little Bit Likely, Somewhat Likely, or Very Likely…You can also answer “don’t know” if that is how you feel.

    	Not at All Likely?	Only A Little Bit Likely	Somewhat Likely?	Very Likely?	Don’t Know
    To use an HIV Vaccine: Vaccines would trigger the body’s defenses to fight HIV. Would you be…
    To use Microbicides: Microbicides would be put in the vagina or rectum to prevent HIV infection. Would you be…
    To use PrEP: Anti-viral medicine that would be taken by people to protect against getting HIV. Would you be…

18. Have you ever had an HIV test? [PROMPT FOR SPECIFIC ANSWER IF YES: “Would you be willing to share the results with me?”]

    	Don’t know
    	No, I didn’t get tested
    	Yes, I was tested
    	[IF YES], Would you be willing to share the result?
    	I would rather not share the results.
    	I tested negative
    	I tested positive
    	I don’t know the result

19. Has someone close to you been infected with HIV/AIDS?

	No
	Yes

Demographics

20. [IF NOT ASKED PREVIOUSLY] How many individuals over the age of 18 are there in your household?

	One
	Two
	Three or More

21. [IF NOT ASKED PREVIOUSLY] What is your ethnicity?

    	Hispanic or Latino
    	Not Hispanic or Latino

22. [IF NOT ASKED PREVIOUSLY] What is your race? Is it…? [CHECK ALL THAT APPLY].

    	American Indian or Alaska Native
    	Asian
    	Black or African American
    	Native Hawaiian or other Pacific Islander
    	White

23. Which of the following categories best describes the highest educational level you attained? Is it…? [CHECK ONLY ONE].

    	Less than a high school diploma
    	High school diploma or GED
    	Some college/technical school/associates degree
    	College degree
    	Some graduate school or more
    	Other (specify):     

24. This past year, what was your total household income before taxes? Was it…?

    	Less than $15K
    	Between $15K-25K
    	Between $25K-50K
    	Between $50K-75K
    	Between $75K-100K
    	$100K or more
    	Don’t Know

25. Are you male, female or transgendered?

	MALE
	FEMALE
	[IF TRANSGENDERED] Are you… Male to female Female to male

26. [IF MALE] In the last five years, have you had sexual contact with a man?

	YES
	NO
	REFUSED

27. [IF MALE] Do you consider yourself to be…?

    		Heterosexual or straight
    		Gay or bisexual
    I have just one more question left but want to give you some information before I ask it. The information is from the National Institutes of Health (NIH). This is what NIH wants you to know about new prevention methods. HIV vaccines, microbicides, and PrEP are not available now outside of clinical trials. They will be made available once they have been proven to be safe and effective. Thousands of healthy people without HIV will be needed in the next several years to help test new methods to prevent HIV infection. Participants’ safety and well-being is carefully monitored and safeguarded. New prevention methods are thoroughly tested for safety before they are studied in clinical trials. You do not need to be exposed to or at risk for HIV to participate in a clinical trial. Participants in HIV prevention clinical trials are counseled to minimize HIV risk, and many clinical trials specifically seek out low-risk participants. Even when new prevention methods are proven to be effective, people will be counseled to avoid exposing themselves to HIV. You cannot get infected with HIV from an HIV vaccine. HIV vaccines do not contain killed or weakened HIV. For more information about HIV prevention methods, go to www.######.org.

28. Now that you know a little more about HIV vaccines, microbicides, and PrEP, how likely are you to talk positively about HIV prevention clinical trials?

How likely would it be that you would talk positively about…?

	Not At All Likely	Only A Little Bit Likely	Somewhat Likely	Very Likely	Don’t Know
a. HIV Vaccine Trial: To develop a vaccine that would trigger the body’s own defenses to fight HIV. Would you be…					
b. Microbicide Trial: To develop gels, foams, or sponges that would be put in the vagina or rectum to prevent HIV infection. Would you be…					
c. PrEP Trial: Anti-viral drugs that would be taken to protect against getting HIV. Would you be…					

29. Are there any comments that you would like to share with NIH regarding the prevention of HIV infections?

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________

What is your full name and address? This is information I need in order to send you $20 for participating in our survey.

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

ScreenerGeneral Population 0