Focus Group Guide

Qualitative research to understand consumer opinions and preferences for emerging

HIV prevention products among MSM in Atlanta, Houston, and Miami

Attachment 2d: Focus Group Guide

Emerging Prevention Products for MSM

Focus Group Guide

• Completed Informed Consent

• Turned on Recorders

FOCUS GROUP TYPE:

___ PrEP Users

___ PrEP Non-users

FOCUS GROUP ID: ________

INDIVIDUAL GROUP MEMBER IDs: _____________________________________________

MODERATOR INITIALS: _______

DATE: _________

START TIME: __:__AM/PM

Form Approved

OMB No: XXXX-XXX

Exp. Date: MM/DD/YYYY

Privacy Act Statement:

This information is collected under the authority of the Public Health Service Act, Section 301, "Research and Investigation," (42 U.S.C. 241); and Sections 304, 306 and 308(d) which discuss authority to maintain data and provide privacy for health research and related activities (42 U.S.C. 242 b, k, and m(d)). This information is also being collected in conjunction with the provisions of the Government Paperwork Elimination Act and the Paperwork Reduction Act (PRA). This information will only be used by the Centers for Disease Control and Prevention (CDC) staff to advance understanding of consumer preferences about emerging biomedical products designed to prevent HIV transmission among men who have sex with men.

Public reporting burden of this collection of information is estimated to average 90 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333. Attn: OMB-PRA (0920-New)

INTRODUCTION AND FOCUS GROUP PURPOSE

Welcome and thank you for agreeing to participate in this study. My name is ________ and I am part of a research team working to understand different perspectives on potential future HIV prevention products similar to daily oral pre-exposure prophylaxis, or PrEP, which is currently available for use. During our discussion, we will be talking about sex, HIV, PrEP, and future prevention products currently in development. We want to hear about what you think about these things. There are no right or wrong answers to the questions I am going to ask. I want to hear, in your own words, your thoughts, experiences and opinions about the topics we will be discussing. Please remember that you can choose not to respond to a question at any time and that your participation in this study is voluntary.

First, I would like to cover the ground rules for this discussion:

• You have been asked here to offer your views and opinions.

• There are no right or wrong answers to the questions.

• We know that each of you might have different views about today's topic and it is ok to disagree with others. If you hear opinions that you do not agree with, we ask that you respectfully listen before you share your own opinion.

• Everyone’s input is important; I may call on you if you are being quiet.

• The study team will keep your answers and information secure and private, so feel free to speak your mind.

• We also ask that you not share comments you hear today with anyone outside of this room. You should know that there is the possibility that a participant may not honor this request.

• Please avoid side conversations.

• Let one person speak at a time.

• I may need to cut a discussion short to get through all of my questions.

• Please turn off your cell phones.

• We will be recording our conversation today so that we have an accurate record of what is said that we can use in writing our report.

Does anyone have any questions before we begin?

[ANSWER ANY QUESTIONS THAT ARISE]

If there are no more questions, I am going to start recording now.

[TURN ON AUDIO RECORDERS]

WARM UP

We will begin by finding out a little bit about each of you. Please write on your name card your nickname or the name you want to use today for our discussion. Then we will go around the table with each person introducing themselves by that name and telling us how long you have lived in the Atlanta area.

[GO AROUND THE TABLE UNTIL EVERYONE HAS INTRODUCED HIMSELF]

Thank you. Now we will get into the discussion.

SECTION 1: PREP USE, KNOWLEDGE, AND OPINIONS

1. When considering HIV prevention methods or products, what aspects are generally important to you? [ALLOW GROUP TO NAME ASPECTS. IF NEEDED, LIST THOSE THAT ARE MENTIONED]

1. Of what you mentioned, which do you think is most important?

2. Which do you think is the least important?

3. Is there anything else you think about when considering HIV prevention methods and products?

Now let’s talk about PrEP, the daily oral pill to help prevent HIV infection. It reduces a person’s chance of becoming infected by HIV by up to 92% when taken consistently.

2. a. [FOR PREP NON-USERS] What are some of the reasons why you are not currently taking daily oral PrEP?

b. [FOR PREP USERS] What are some of the reasons why you are currently taking daily oral PrEP?

PROBE: Has anyone used PrEP before but then stopped? [IF SO, TAKE A COUNT]

Why did you stop?

Did anyone start back up again? Why did you start again?

SECTION 2: EMERGING PREVENTION PRODUCTS

Now we are going to talk about a few HIV prevention products that are currently under development and may be available for you to use in the future. As you know, there is currently only a daily oral pill available for PrEP to reduce your risk of getting HIV infection. For the purposes of this discussion, we will assume all of these products are as effective as the current daily oral pill for PrEP.

I am going to show an example of each of these products and get your opinions about them.

3. The first example is a weekly oral pill that you would take once a week. You would have to take it around the same time of day every seven days, for example every Monday at 8 pm, for each dose to be effective. You would receive a 3-month supply (12 pills). [PRESENT PROTOTYPE AND PRODUCT GRAPHIC]

1. What do you like about this option?

2. What do you NOT like about this option?

3. What changes might you suggest that could make you more interested in taking this form of PrEP someday?

4. The next example is an intermittent or sexual event-specific oral pill. For this form of PrEP, you would take two pills 2 to 24 hours before having anal sex and then you would take one pill a day for 2 days after sex (24 hours after the first 2 pills, another pill 24 hours after the 3^rd pill). So, that is 4 pills in total, taken just before and after sex to be effective. You would receive a 3 month supply (16 pills per a month a total of 48 pills) [PRESENT PROTOTYPE AND PRODUCT GRAPHIC]

1. What do you like about this option?

2. What do you NOT like about this option?

3. What might you suggest that could make you more interested in taking this form of PrEP someday?

5. The next example is an anal suppository or solid dissolvable medication that would be inserted into the anus before having anal sex. Once inside the anus, it dissolves and spreads throughout the rectum. It would be inserted 1-24 hours before sex and be effective for up to 24 hours per dose and for multiple anal sex acts. [PRESENT PROTOTYPE AND PRODUCT GRAPHIC]

1. What do you like about this option?

2. What do you NOT like about this option?

3. What changes might you suggest that could make you more interested in taking this form of PrEP someday?

6. The next example is an anal douching product that is a powder-like substance you would mix with water (the amount you would usually use for douching) or a commercially available douching product. Then you would insert the mixed product into your anus or rectum and hold in for about four minutes before releasing. It would be used 30-60 minutes before sex and be effective for up to 24 hours per dose and for multiple anal sex acts. [PRESENT PROTOTYPE AND PRODUCT GRAPHIC]

1. What do you like about this option?

2. What do you NOT like about this option?

3. What changes might you suggest that could make you more interested in taking this form of PrEP someday?

7. The next example is an injection or a shot that would be injected into the muscle of the butt. Before the first injection, you would take an oral tablet daily for 5 weeks. If no side effects, then you would receive an injection. To be effective, the injection would be administered by a healthcare provider such as a nurse. The first two injections would be four weeks apart. After this the injections will be reduced to one injection, every eight weeks. [PRESENT PROTOTYPE AND PRODUCT GRAPHIC]

1. What do you like about this option?

2. What do you NOT like about this option?

3. What changes might you suggest that could make you more interested in taking this form of PrEP someday?

8. The final example is a skin implant product that a doctor or healthcare provider would inject or insert under the skin of the upper arm. First, they would anaesthetize the insertion area. Then, the implant will be inserted. It would be effective for up to six months. After it expires, the doctor or healthcare provider would remove the implant through a small incision or cut in the skin and then you could get a new implant. [PRESENT PROTOTYPE AND PRODUCT GRAPHIC]

1. What do you like about this option?

2. What do you NOT like about this option?

3. What changes might you suggest that could make you more interested in taking this form of PrEP someday?

9. Now that you have heard about all of these products, here are placards with the names and brief descriptions of prevention methods, including condoms, the daily PrEP pill that is already available, and all the other forms of PrEP that we have discussed. As a group, we will now rank order them based on their appeal to you and your preferences. [PRESENT SHOW CARDS]

• Condoms

• Daily PrEP (a pill that you take every day)

• Event-driven PrEP (two pills before sex and one pill for two days after sex)

• Weekly oral PrEP (take consistently every week)

• Injectable PrEP (a shot you receive every 3 months)

• Implant PrEP (an implant in your arm every 6-12 months)

• Anal suppository (a pill size dose you put in your anus or butt before sex)

• Rectal microbicide through anal douching that is used before sex (a fluid you put in your rectum)

1. [FOR PREP NON-USERS] Assuming that they are all effective, which product is least appealing/preferred? Why? Which product would be listed next?

[Continue ranking and probing for rationales for placement until products are in rank order from least to most appealing/preferred]

2. [FOR PREP USERS] Assuming that they are all effective, which product is least appealing/preferred? Why? Which product would be listed next?

[Continue ranking and probing for rationales for placement until products are in rank order from least to most appealing/preferred]

CLOSING

Thank you for your time and thoughtful responses. That is all the questions that I have. Is there anything more anyone would like to say about the future prevention products that are under development?

[PAUSE FOR RESPONSE]

Thank you again for talking with us about these topics today. I will turn off the recorders and give you your $60 now.

[TURN OFF RECORDERS]

END TIME: __:__AM/PM