Interest in I-PrEP and Willingness to Participate in Clinical Trials Among Men and Transfeminine Persons Who have Sex with Men in Sub-Saharan Africa: Quantitative and Qualitative Findings from HPTN 075

Abstract

This study explored interest in injectable PrEP (I-PrEP) and willingness to participate in clinical trials testing new biomedical HIV prevention strategies among men and transfeminine persons who have sex with men (MSM & TGP), using data collected in the HIV Prevention Trials Network (HPTN) 075 study, which took place at sites in Kenya, Malawi, and South Africa. Data result from a survey among 267 18–44 years old HIV negative participants, complemented with semi-structured interviews with 80 purposively recruited persons. Correlations coefficients were calculated to identify demographic and psychosocial factors associated with interest in I-PrEP. Qualitative interviews were analyzed using concept-driven and subsequent data-driven coding. Most surveyed participants expressed an interest in I-PrEP. Quantitatively, only being interested in other HIV prevention measures was associated with interest in I-PrEP. Qualitatively, most participants preferred I-PrEP to O-PrEP and remained interested in I-PrEP despite barriers such as the somewhat invasive nature of the procedure and potential side effects of I-PrEP. Interest in I-PrEP was driven by the possibility of avoiding sexual or HIV stigma. Access to healthcare and altruism—such as assisting in the development of new HIV prevention methods—positively impacted willingness to participate in clinical trials. With I-PrEP favored by most participants, it is potentially a critical tool to prevent HIV infection among MSM & TGP in sub-Saharan Africa, with the mitigation of stigma as a major advance. Recruitment of MSM & TGP in biobehavioral clinical trials seems feasible, with altruistic reasons and receiving I-PrEP and free medical care as major motivators.

Resumen

Este estudio exploró el interés en la PrEP inyectable (I-PrEP) y la voluntad de participar en ensayos clínicos que prueban nuevas estrategias biomédicas de prevención del VIH entre hombres y personas transfemeninas que tienen sexo con hombres (HSH y TGP), utilizando datos recopilados en la Red de Ensayos de Prevención del VIH. (HPTN) 075, que se llevó a cabo en sitios de Kenia, Malawi y Sudáfrica. Los datos son el resultado de una encuesta entre 267 participantes VIH negativos de entre 18 y 44 años, complementada con entrevistas semiestructuradas con 80 personas reclutadas intencionalmente. Se calcularon coeficientes de correlación para identificar factores demográficos y psicosociales asociados con el interés en la I-PrEP. Las entrevistas cualitativas se analizaron mediante codificación basada en conceptos y, posteriormente, basada en datos. La mayoría de los participantes encuestados expresaron interés en la I-PrEP. Cuantitativamente, sólo estar interesado en otras medidas de prevención del VIH se asoció con el interés en la I-PrEP. Cualitativamente, la mayoría de los participantes prefirieron la I-PrEP a la O-PrEP y siguieron interesados en la I-PrEP a pesar de barreras como la naturaleza algo invasiva del procedimiento y los posibles efectos secundarios de la I-PrEP. El interés en la I-PrEP fue impulsado por la posibilidad de evitar el estigma sexual o del VIH. El acceso a la atención sanitaria y el altruismo (como la asistencia en el desarrollo de nuevos métodos de prevención del VIH) tuvieron un impacto positivo en la voluntad de participar en ensayos clínicos. Dado que la mayoría de los participantes prefieren la I-PrEP, es potencialmente una herramienta crítica para prevenir la infección por VIH entre HSH y TGP en el África subsahariana, con la mitigación del estigma como un avance importante. El reclutamiento de HSH y TGP en ensayos clínicos bioconductuales parece factible, con razones altruistas y recibir I-PrEP y atención médica gratuita como principales motivadores.

Appendices

Appendix 1

PrEP-Related Survey Questions HPTN 075: Third Study Visit

Variable Name (VN): INTPEP

Have you ever heard of PEP, post-exposure prophylaxis?

{IF INTPEP = 1: Just to make sure it’s clear what we are talking about,} PEP is the use of HIV medications as soon as possible after exposure to HIV to prevent your body from becoming infected with HIV. Emergency PEP contains the same medicines that people with HIV take to stay healthy. These medicines stop the virus from multiplying in your body. PEP can reduce the chance of infection if you are exposed to HIV. PEP can for instance be taken after a condom broke or because you didn’t use a condom but had sex with someone who was HIV positive.

VN: INTUSEPEP

If you were to have an exposure to HIV in the next 12 months, how likely would you be interested in using PEP to prevent HIV if it would be available to you?

VN: INTSTILLPEP

With PEP, you take HIV medications for 28 days, usually once or twice a day. How hard or how easy would it be for you to take HIV medications for 28 days?

I would now like to talk with you about PrEP. PrEP stands for Pre-exposure prophylaxis. Have you ever heard of PrEP?

{IF INTPREP = 1: Just to make sure it’s clear what we are talking about,} With PrEP you take HIV medication to reduce the chances of getting HIV infected. You would need to take this medication every day whether you planned to have sex that day or not. If you don’t take it every day PrEP is not as effective.

VN: INTUSEPREP

If it would be possible for you to get PrEP, how interested would you be in using it?

SHOW IF INTUSEPREP < 3

VN: INTSTILLPREP

The medication would have to be prescribed by a doctor. That doctor would need to see you at least every 3 months to test you for HIV infection and other medical checkups. Would you still be interested in PrEP?

SHOW IF INTSTILLPREP < 3

VN: INTSIDEEFFECT

There are some side effects reported by people who start taking HIV medication, mostly nausea and weight loss that goes away after the first month or so. In rare cases, HIV medication taken for long periods can damage the kidneys. Given these side effects, would you still be interested in PrEP?

SHOW IF INTSIDEEFFECT < 3

VN: INT3MON

How hard or how easy would it be for you to take PrEP every day and to see a doctor every 3 months for checkups?

VN: INTINJECT

Imagine that you could get PrEP via an injection. You would have to see a doctor once every 3 months. The injection that the doctor gives you would reduce your chances of getting infected with HIV for 3 months. And then you would have to see the doctor again. This is called injectible PrEP. How interested would you be in having injectible PrEP? Would you say…

SHOW ALL

VN: INTMICROB

I would now like to talk with you about Microbicides. Have you ever heard of Microbicides?

{IF INTMICROB = 1: Just to make sure it’s clear what we are talking about,} Microbicides are gels or creams that people can put in their rectum or vagina to prevent HIV infection. At this moment there are no microbicides that have proven to be effective. Imagine that an effective microbicide would become available.

VN: INTUSEMICROB

If you were having anal sex with a partner in the next 12 months, how likely would you be to use rectal microbicides if you were the bottom partner?

Appendix 2

Qualitative HPTN 075 Substudy: In-Depth Interview

	Topic/question	Aim
	PrEP
1	We now have another way of protecting oneself against HIV infection. It is called PrEP, or pre-exposure prophylaxis. Have you ever heard about PrEP? – Where have you heard about PrEP, or from whom? – What have you heard about PrEP? – How would you describe what PrEP is? – How do you understand that PrEP protects people? – Do you know anybody who has taken PrEP?	Before exploring PrEP more deeply, it is helpful to understand men’s current awareness and understanding of PrEP. This also allows us to detect any misinformation men might have
2	To make sure that we are talking about the same topic, let me give you a description of what PrEP is	We provide a definition to ensure that all men have the same information in the interviews
	PrEP stands for pre-exposure prophylaxis. It is a pill that you take once a day and that can keep you HIV negative. If you take it every day, PrEP can lower the risk of getting HIV by 92–99%. This medication is also used by people who are HIV positive to fight off the virus	It is important to be aware that PrEP regimens might change To keep things simple, we don’t talk about condoms here (but formally, condom use in recommended in combination with PrEP) Also not mentioned, but important to be aware of is that PrEP does not protect against STI
	To be clear, PrEP differs from PEP. PEP stands for post-exposure prophylaxis; PEP is taking HIV medication to prevent infection after someone might have been exposed to HIV	We have to make sure that men distinguish PrEP from PEP
	PrEP has been shown to be very safe. As with any medication there may be minor side effects, though. Some people get an upset stomach when they first start taking it. In order to get PrEP, you have to see a doctor every 3 months, to get an HIV test, to refill your prescription, and to follow-up In the United States, PrEP is approved by the Food and Drug Administration. In our country [FILL IN CURRENT STATUS OF APPROVAL] – Do you have any questions about PrEP?	We should provide answers to questions men might have about PrEP
3	How do you think the MSM you know would respond to learning about PrEP, what would they think about it? – Would the MSM that you know be interested in using PrEP? – Why do you think that MSM would be interested in PrEP? – Could you think of any reasons why MSM would not be interested in using PrEP? – Would PrEP be better for some types of MSM than for others? Can you explain? – What kind of men do you think would be interested in using PrEP? – What would you think of someone who uses PrEP to protect himself?	With these questions we give person the opportunity to express his general ideas about PrEP before talking about PrEP for himself; the former is probably easier and facilitates the latter
4	How would you personally feel about using PrEP? – Would you yourself be interested in using PrEP? – What do you see as the advantages of using PrEP? – What do you see as the disadvantages of using PrEP? – If you compare PrEP with the other ways of protecting oneself against HIV infection that we have talked about before, which one would you prefer most? Can you explain?	These and following questions are based on procedures to elicit salient determinants of behavior (beliefs, social norms, self-efficacy, barriers and facilitators, and intentions) (See: Middlestadt, S.E., K. Bhattacharyya, J. Rosenbaum, M. Fishbein, and M. Shepherd, The use of theory based semistructured elicitation questionnaires: Formative research for CDC’s Prevention Marketing Initiative. Public Health Rep, 1996. 111: pp. 18–27.)
	Injectable PrEP
5	One of the disadvantages of PrEP as a pill, is that you would have to take it every day. Otherwise it is not effective. For that reason, researchers are exploring other ways to administer PrEP. One way is by injecting PrEP with a needle into someone’s buttocks. We call that “injectable PrEP.” Such “shots” are long acting; that means that they stay in your body for a long time There are now studies going on to test whether such an injection is safe and whether it will work to protect people from getting HIV	We provide a definition to ensure that all men have the same information about injectable PrEP. We start with a global definition; more information will come when we further explore the man’s interest in injectable PrEP
6	Imagine that injectable PrEP is safe and it protects people from getting HIV just as well as oral PrEP does. People who decide to use it would probably have to get an injection every 2 months and they also have to have blood drawn to test for HIV and STI each time What do you think: would the MSM that you know be interested in injectable PrEP? – Why do you think that MSM would be interested in injectable PrEP? – Are there reasons why they might not be interested? – What do you think that MSM would prefer more: taking a pill every day or getting an injection in their buttocks once every 2 months?	We start talking about the interest of MSM’s in injectable PrEP in general to facilitate expressing one’s personal interest
7	What about for yourself: If you were to take PrEP, what would you think about taking a pill every day compared getting an injection in your buttocks once every 2 months? – Can you explain? – What might be some of the advantages of taking a pill every day compared to an injection? – What might be some of the advantages of having an injection every 2 compared to taking a pill every day?
8	How do you feel in general about getting injections, for instance for vaccines? – What kind of injections have you ever received? – How did you feel about these injections?	Eliciting how the person generally feels about getting an injection is likely to make responses to subsequent questions more real
9	PrEP will be injected with a needle that is relatively thick, like this one [SHOW NEEDLE]. From studies we have learned that injections with PrEP can be painful and that the pain can last for several days. Some people had a sore butt for several days and that made it hard for them to do their work. Other people have said that they experienced irritation, skin redness, bumps, swelling, itching, and bruising where they got the shot – How would you feel about this? – How might this impact your opinion about injectable PrEP?	To assess whether an injection and associated pain affects interest in PrEP
10	Injectable PrEP also has other potential side effects such as headaches, diarrhea, fatigue, muscle aches, nausea, fever and dizziness – How would you feel about such side effects? – How might this impact your opinion about injectable PrEP?	To assess whether potential side effects affect interest in PrEP
11	One of the potential advantages of injectable PrEP is that it is long acting. That means that a shot stays in your body for a long time, up to 1 year. But that also means that If you develop side effects after the shot, there will be no way to remove the drug from your body – How would you feel about this? – How might this impact your opinion about injectable PrEP?	To assess whether not being able to “undo” the shots and the potential long lasting side effects affect interest in PrEP
	Participation in injectable PrEP efficacy studies
12	As I told you, there are now studies going on to test whether such a PrEP injection is safe and whether it will work to protect people from getting HIV I would like to know whether you, in principle, would be interested in participating in such a study What are your initials thoughts about this? – Could you explain why you would (not) be interested in participating in such a study? – What would it depend upon? IF DEFINITELY NOT INTERESTED: END INTERVIEW	Before providing a lot of details about participation in an injectable PrEP efficacy study, it is important to assess overall interest first It is also important to let the participant explain his answer before providing more information: why would or would he not be interested in participating? If “it depends,” what does it depend upon?
13	As part of these studies, you would also be expected to participate in several medical exams. Your blood will be drawn at each visit. Study staff will also perform a swab of your rectum and collect urine – How would you feel about this? – How might this impact your interest in participating in such a study?	Be aware: in most studies about injectable PrEP, participants start with oral PrEP to make sure that they are not hyper sensitive. We don’t explain this, because it makes it too complicated
214	These kinds of studies last a long time. One of the current studies will last for more than 4 years and study participants have to come to the clinic more than 50 times – How would you feel about this? – Would it be possible for you to come so often to the same place over such a long period of time? – How might this impact your interest in participating in such a study?	These questions serve to assess whether study length affects the man’s willingness to participate
15	People who participate in such a study are placed in one of two groups. The first group gets the injection with the drug in it. The other group will get something called a “placebo” that does not contain the real drug. Placebos look and feel like the real drug, but they do not contain any of the real drug or any other medicines. Comparing the two groups allows researchers to see whether a drug works The group you would be assigned to would be chosen randomly. It is like flipping a coin. You cannot choose which group you are assigned to. You will also not know what group you are in. Until the end of the study, not you or the study researchers, doctors or nurses will know which group you were in – How would you feel about this? – How might this impact your interest in participating in in such a study? – Imagine that you were to participate in such a study: how likely do you think it is that you would be assigned the group that gets injected with the real drug? – Would you say it is very likely, likely, unlikely, or very unlikely, or would the chances be even? Can you explain your answer?	These questions serve to assess whether the man understands what participation in an experimental study implies and whether potentially not getting the drug affects his willingness to participate Be aware that in HPTN 083 participants also get Truvada or a placebo pill, in addition to the injection. Explaining that here would make the issue too complicated
16	One of the reasons for doing a study like this is to figure out if the drug really protects against HIV infection. That means that if you are in the group that gets the injection with the real drug, it is not clear that it protects you against HIV infection – How would you feel about this? – How might this impact your interest in participating in such a study?	This question serves to assess whether uncertainty about efficacy affects the man’s willingness to participate
	End
17	Is there anything that we have not discussed yet that you think might be relevant?
18	Would you have any questions for me?