In-depth Interview Guide

Qualitative research to understand consumer opinions and preferences for emerging

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

Attachment 2c: In-Depth Interview Guide

Emerging Prevention Products for MSM

In-Depth Interview Guide

• Completed Informed Consent

• Turned on Recorders

IDI TYPE:

___ PrEP User

___ PrEP Non-user

RESPONDENT ID: ________

INTERVIEWER INITIALS: _______

DATE: _________

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 60 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)

START TIME: __:__AM/PM

INTRODUCTION AND 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.

Do you have any questions before we begin?

[PAUSE FOR REPONSE]

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

[TURN ON AUDIO RECORDERS]

Now that I have the recorders on, may I have your verbal permission to record our interview today?

SECTION 1: PREP USE, KNOWLEDGE, AND OPINIONS

1. Which HIV prevention methods or products have you personally used? Why?

1. What are some of the things you think about when considering choosing between HIV prevention methods or products?

2. PROBE: Anything else? Of what you mentioned, which do you think is most important?

3. Which do you think is least important?

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.

[If NOT taking PrEP] 2. Tell me about why you are not currently taking daily oral PrEP. Probes: Have you used PrEP before? Why did you stop? Have you attempted to take or access PrEP but you weren’t able to? What happened? What are your thoughts about taking oral daily PrEP in the future? Can you think of a different time in your life when you might start taking daily PrEP?”

[If taking PrEP] 2. Tell me about why you are currently taking daily oral PrEP. Probes: Have you used PrEP before and stopped? Why did you stop? Why did you start again? What are some of your thoughts about continuing to take oral daily PrEP in the future? Under what life circumstances might you stop taking oral daily PrEP?

SECTION 2: EMERGING PREVENTION PRODUCTS

Now we are going to talk about a few HIV prevention products that may be available for use in the future. As you know, as of now there is only a daily oral pill for PrEP currently available 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 you 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 would you suggest that would make you more interested in taking this form of PrEP someday?

PROBE: Have you ever taken a weekly pill before? How did that go?

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 3rd 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 changes would you suggest that would make you more interested in taking this form of PrEP someday?

4. Tell me how you feel about taking oral pills, in general?

PROBE: Tell me about any problems you may have had taking oral pills as prescribed.

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. Have you ever used anal suppositories?

PROBE: Tell me about any problems you may have had using them.

4. What changes would you suggest that would 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 in 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. Have you ever used an anal douching product?

PROBE: Tell me about any problems you may have had using them.

4. What changes would you suggest that would 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. How do you feel about injections, in general?

PROBE: Tell me about any problems you may have had with injections.

4. What changes would you suggest that would make you more interested in taking this form of PrEP someday?

8. The final example is a skin implant product that would be injected or inserted under the skin of the upper arm by a healthcare provider such as a nurse. 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 implant would be removed by a small incision or cut in the skin and you would then 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. Have you ever used a skin implant product?

PROBE: Tell me about any problems you may have had using them.

4. What changes would you suggest that would make you more interested in taking this form of PrEP someday?

9. Now that you have heard about all of these products, here is a list of prevention methods, including condoms, the available daily pill, and all the other forms of prevention that we have discussed. [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-user]

1. Assuming that they are all effective at preventing HIV, which of these products would you prefer to use? Why?

2. Which would work best with your primary sexual partners? Why?

3. Which would work best with your casual sexual partners? Why?

4. Which of these products is least appealing? Why?

1. [For PrEP User]

1. Assuming that they are all effective, would you prefer any of these products to use instead of daily oral PrEP? Which one(s)? Why or why not?

2. Which would work best with your primary sexual partners? Why?

3. Which would work best with your casual sexual partners? Why?

4. Which of these products is least appealing? Why?

10. Is there anything else about HIV prevention products that you would like to discuss?

CLOSING

Thank you for your time and thoughtful responses. I will turn off the recorders and give you your $40.

[TURN OFF RECORDERS]

END TIME: __:__AM/PM