PrEParing for NextGen: cognitive interviews to improve next generation PrEP modality descriptions for young men who have sex with men

Abstract

Next generation PrEP formulations may circumvent factors that impede daily oral pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). We conducted video-based cognitive interviews with 20 YMSM (age 16–24) recruited in the US Northeast to assess participants’ attitudes and comprehension of written descriptions of next generation PrEP modalities. Participants were predominately racial/ethnic minorities and half used daily oral PrEP. We identified four main areas for improvement of descriptions: defining scientific terms and balancing medical jargon and casual language; referencing more established products to contextualize PrEP formulations (e.g., hormonal implants); ensuring clarity and reducing redundancy; and including imagery (e.g., rectal douche applicator). The refined descriptions serve as exemplar text that may be used in future studies examining YMSM’s preferences across next generation PrEP modalities. Accurate descriptions of next generation PrEP products strengthen measurement accuracy and can help roll-out products that become approved for clinical use.

INTRODUCTION

HIV incidence in the United States (US) is growing most rapidly among men who have sex with men (MSM). Pre-Exposure Prophylaxis (PrEP) can help reduce HIV infections among MSM, yet PrEP uptake and daily PrEP adherence remains low. While there has been a recent five-fold increase in PrEP uptake among adult MSM in urban areas in the US (1), adolescents account for less than 1% of new PrEP prescriptions (2, 3). This trend is particularly troubling, as young MSM (YMSM; ages 13–24) account for nearly one-third of new infections among MSM in the US (4). Despite their high PrEP need, only 3% of eligible YMSM have been prescribed PrEP, substantially lower than their older peers (5, 6); PrEP uptake among YMSM under 18 years old is even lower, contributing to continued HIV transmission among this group (2). Among YMSM with a PrEP prescription, adherence to daily oral PrEP and retention in PrEP care is also substantially lower than adult MSM (7, 8), jeopardizing the real-world impact of PrEP in this population.

Factors impeding daily oral PrEP uptake and adherence among YMSM include cost, accessibility, side effects, stigma, and competing stressors (9–14). Access to daily oral PrEP is even more limited for YMSM under 18 years old due to developmental circumstances (e.g., establishing identities, vulnerability to stigma, inexperience navigating the healthcare system), and lack of access to HIV prevention services without parental consent in some jurisdictions (15–19). Taking these considerations into account, HIV prevention scientists are actively developing and testing the efficacy of next generation PrEP formulations that could circumvent some of the challenges with daily oral PrEP. These next generation PrEP formulations include diverse drug delivery mechanisms (e.g., douches, injectables, implants) that could expand users’ HIV prevention choices based on their sociocultural context, behavioral patterns, and desire for episodic or long-acting protection (20). For example, rectal douches may be congruent with cleansing practices and behaviors regarded as normative prior to participating in activities where the probability of engaging in receptive anal intercourse is high (21, 22). Similarly, infrequent injectable formulations or episodic oral PrEP might be more compatible with a complex lifestyle where taking a pill every day is unrealistic. As next generation HIV prevention products advance in the research development pipeline, understanding the acceptability and preferences among YMSM is key to future implementation of products found to be efficacious in clinical trials.

At present, limited research has examined YMSM’s understanding and comprehension of these next generation PrEP products, particularly those that remain in development. Preliminary investigations show that YMSM may have deficient understanding of information about next generation PrEP products provided during clinical trials (17, 23). Without clear descriptions of these next generation products, researchers’ efforts to examine the hypothetical acceptability of these products and/or to describe these innovative products during clinical trial recruitment or to educate and market clinically effective products may be compromised. Standardized definitions of different PrEP products may increase validity of clinical and behavioral PrEP research and facilitate comparison of findings across studies. Therefore, we conducted a series of cognitive interviews with YMSM to ascertain their comprehension and interpretation of the descriptions of daily oral PrEP as well as five next generation HIV prevention products (e.g., intermittent oral PrEP, injectable PrEP, PrEP implants, PrEP douches, and broadly neutralizing antibodies (bnAbs). We discuss the findings from these cognitive interviews below and offer PrEP descriptions that may be used in future studies with YMSM and other young populations.

METHODS

Between April and May 2020, we recruited 20 YMSM to participate in our cognitive interview study. Individuals were eligible to participate if they met the following criteria: 15–24 years old; assigned male sex at birth and currently identifying as male (i.e. cisgender man); self-reported being HIV-negative or HIV status unknown; reported at least one episode of condomless anal sex with another man or transgender woman in the past six months; and English-speaker. Participants were recruited online through posts on websites and social media platforms (e.g., Craigslist, Facebook) and targeted email lists and were selected purposively to ensure diversity with respect to race/ethnicity and previous experience with oral PrEP. Interested individuals completed an online screener survey to determine eligibility. Study staff contacted eligible individuals on the phone to confirm eligibility and schedule their online interview.

We obtained a waiver of parental consent for participation of individuals 15–17 years old. All participants provided online informed consent/assent. The Institutional Review Board at University of North Carolina at Chapel Hill reviewed and approved all study procedures and materials.

Study Procedures

Participants met with trained interviewers online via SecureVideo, a HIPAA-compliant videoconferencing platform, to explain study procedures and provide informed consent. After providing online informed consent, participants completed a brief self-administered online survey to contextualize the interview data. Measures (see Table 1) included age, sexual behaviors (i.e., number of partners and condomless anal sex acts in the past 6 months), race, Hispanic ethnicity, sexual orientation, education, HIV and STI testing history, and PrEP awareness, interest and current use. Trained interviewers then conducted in-depth interviews following a semi-structured guide developed by the research team.

Table 1 –

Sociodemographic characteristics of participants in cognitive interviews (N=20).

	Mean (SD)
Age (range: 16–24)	21.0 (2.27)
Number of male and trans female partners, past 6 months (range: 1–11)	3.65 (3.05)
Number of male and trans female partners – condomless, past 6 months (range: 1–9)	2.55 (1.96)
Condomless anal sex acts, past 6 months (range: 1–60)	9.58 (13.91)
	N (%)
Age group
Under 18 years old	2 (10%)
18 years and older	18 (90%)
Recruitment site
Philadelphia, PA	10 (50%)
Providence, RI	10 (50%)
Hispanic/Latinx	4 (20%)
Race
White	10 (50%)
Asian	5 (25%)
Black	2 (10%)
Multiracial/Other	2 (10%)
Sexual orientation
Gay/homosexual	15 (75%)
Bisexual	5 (25%)
Currently in school	11 (58%)
Highest level of education completed
Less than high school	2 (10%)
Graduated high school/GED	3 (15%)
Some college/tech or vocational school	7 (35%)
Four-year college graduate or more	8 (40%)
HIV test
In past 6 months	11 (55%)
Ever	17 (85%)
STI test
Ever	18 (90%)
Heard of PrEP prior to study	19 (95%)
Taking PrEP	10 (50%)
Interested in taking PrEP (among those not on PrEP)
Extremely likely	2 (20%)
Likely	2 (20%)
Undecided	5 (50%)
Unlikely	1 (10%)

For cognitive interviews, participants were instructed to read and evaluate written description of next generation HIV prevention products (i.e., PrEP delivered as on-demand oral medication, intramuscular injections, subcutaneous implants, rectal douches, and broadly neutralizing antibodies [bnAbs]) for clarity and cultural appropriateness. To reduce participant burden, each participant was asked to review descriptions of four randomly selected next generation HIV prevention products. The initial descriptions (see Table 2) were developed collaboratively by the research team based on our previous research on HIV prevention among YMSM (i.e., “expert appraisal”) (24) and through a content analysis of language used among youth in the US to discuss sexual health and practices on social media (25). Using a concurrent verbal probing approach (26), interviewers assessed participants’ comprehension, attitudes, cultural appropriateness, thought-processes evoked while interpreting written descriptions of next generation HIV prevention products, and suggestions for refinement of the descriptions (see Table 3 for specific probes used). Participants also provided recommendations on imagery that could facilitate greater understanding of each HIV prevention technology. In total, interviews lasted approximately 60 minutes (cognitive interview portion lasted ~20 minutes) and were audio-recorded and professionally transcribed. Interviewers also probed a variety of topics related to health care and HIV prevention (e.g., experiences with HIV/STI testing and STI treatment) to contextualize the cognitive interview component. Participants received $50 for their participation in the study.

Table 2 –

Original and revised description of next generation PrEP products with images

	Original	Final (with major changes underlined)	Image
Daily oral PrEP	A medical HIV prevention method called Pre-Exposure Prophylaxis, or PrEP, has shown to be safe and effective to prevent HIV infection. People who use Pre-Exposure Prophylaxis, or PrEP who take a pill every day reduce the chances of becoming infected if they came in contact with HIV. The medication is prescribed by a doctor who would need to see you at least every 3 months to test you for HIV infection and other STIs (sexually transmitted infections) and check your kidneys.	Daily oral PrEP is the use of medical drugs as an HIV prevention method to reduce the chances of getting HIV. Taking one PrEP pill once a day every day has been shown to be up to 99% effective at preventing HIV. The medication is prescribed by a doctor or other clinician, who will need to see you to test you for HIV and other STIs (sexually transmitted infections) and have additional blood work done to check for side effects every 3 to 6 months.
Intermittent PrEP	On-demand PrEP—also known as event-driven PrEP, 2+1+1, or intermittent PrEP—has been shown to work as well as daily PrEP when taken as two pills between 2 and 24 hours before a condomless sex encounter, followed by another pill 24 hours after condomless anal sex and another pill 24 hours after that. The medication is prescribed by a doctor who would need to see you at least every 3 months to test you for HIV infection and other STIs and check your kidneys.	On-demand PrEP – also known as event-driven PrEP or intermittent PrEP – is a way of taking oral PrEP only around the time when you are planning to have sex (as compared to taking a pill once daily). The medication is prescribed by a doctor or other clinician who will also need to test you for HIV and other STIs (sexually transmitted infections), and have your blood work done to check for side effects every 3 to 6 months.
PrEP Implant	Another form of PrEP that might be available in the future is an implant. Implants are match-stick-sized plastic capsules containing medicine that can be put under the skin in your arm or another part of your body. Implants release medication slowly over a longer period of time, so getting an implant to prevent HIV could protect you against HIV infection for up to one year.	PrEP implants are matchstick-sized capsules (about 1 ½ inches) containing medicine that is inserted under the skin of your upper arm (like hormones or contraceptives) by a health care professional. PrEP implants release medication slowly, so getting a PrEP implant would protect you against HIV infection for a longer period of time. You will also need to get tested for HIV and other STIs (sexually transmitted infections), and have your blood work done to check for side effects every 3 to 6 months.
PrEP Douche	Some researchers are also testing whether inserting PrEP as a rectal douche could protect against HIV. A rectal douche is a liquid inserted into the rectum, or butt, with an applicator. The applicator is removed after inserting the rectal douche and the liquid is expelled before sex.	A douche uses a solution to clean the rectum, or butt, before receptive anal sex (bottoming). PrEP medication prescribed by a doctor or other clinician is added to the bulb or enema bottle as part of the normal douching routine. The PrEP medication is absorbed quickly into the body and protects the receptive partner against HIV for several days. You will also need to get tested for HIV and other STIs (sexually transmitted infections), and have your blood work done to check for side effects every 3 to 6 months.
Injectable PrEP	Another form of PrEP that is currently being tested is an injection, or a shot, given by a doctor or nurse every 2 months. Instead of taking a pill by mouth every day, studies are underway to determine if having a shot every two months will offer protection against HIV.	With injectable PrEP, a needle containing PrEP medicine is inserted into the muscle by a health care professional (like a flu shot or hormone injection). The medicine stays in your body to prevent HIV infection for a longer period of time. You will also need to get tested for HIV and other STIs (sexually transmitted infections), and have your blood work done to check for side effects every 3 to 6 months.
bnABs	Researchers have found antibodies (that is, proteins in the body that develop in response to a virus) in some HIVinfected people that are believed to be linked to protection against becoming sick. In studies with monkeys, intravenous infusions of these antibodies (that is, a slow “drip” of a medicine made from these antibodies into the veins) protect against infection. Initial studies in humans have found the antibody infusions to be safe and welltolerated. Studies are currently under way to determine whether this approach is effective in protecting against HIV in humans.	Antibodies are proteins in the body that develop in response to being exposed to a virus. Scientists have found antibodies that may protect against getting HIV. These antibodies are given by a health care professional as intravenous (IV) infusions, which is a slow “drip” of a medicine made from these antibodies into the bloodstream. The infusion of these antibodies would protect against HIV for a longer period, but you would need to receive additional infusions for continued protection. You will also need to get tested for HIV and other STIs (sexually transmitted infections), and have your blood work done to check for side effects every 3 to 6 months.

Table 3 –

Sample Probes from Cognitive Interviews

Probes
• Please describe in detail what you are thinking as you read the excerpt above.
• Overall, how easy or difficult was this for you to understand? What was easy? What was difficult?
• In your own words, what do you believe these descriptions are aiming to describe?
• Is there anything we can change or add that would make these descriptions clearer (e.g., images, examples of other similar products)?
• Was the wording clear? Was there a word that you focused on to understand this more than another?
• How did you interpret the description, what does it mean to you?
• How would you restate the description if you had to use your own words?
• What were you thinking of, recalling, or picturing when you read this description?
• Was it clear how this product description differed from the others?
• Do you have suggestions for how the description could be re-worded to make it clearer and better understood by young men who have sex with men?

Analytic Strategy

Upon completion of data collection, written descriptions of each HIV prevention technology were modified according to the procedure outlined by Willis (26). First, the research team systematically reviewed all interview audio-recordings for participants’ feedback on length, complexity, ambiguity of words or phrases, and attitudes and reactions provoked by the written descriptions. Potential modifications and suggestions emerging in the analysis of interview recordings were compared with analytic memos (27) on participants’ perceptions and experiences reading and interpreting the instruments created by interviewers immediately after interviews, ensuring a thorough and efficient analysis of cognitive interview findings to inform modification of written descriptions of next generation HIV prevention products (26). One of the co-authors, who has graphic design experience, created images to illustrate HIV prevention technologies based on participants’ suggestions. Dedoose software was used to sort and categorize the emergent findings from the qualitative data.

Modified descriptions and images were iteratively reviewed by the entire research team until consensus was reached. From these findings, revised product descriptions and images were generated, ensuring that the key features highlighted by participants were incorporated. These revised descriptions and images were presented for feedback on readability and cultural relevance and appropriateness to a Youth Advisory Board comprised by a racially/ethnically diverse group of sexual and gender minority youth with experience collaborating on HIV and sexual health research.

RESULTS

Sample characteristics are noted in Table 1. Participants’ mean age was 21 (range: 16–24). Most participants identified as racial/ethnic minorities (n=12, 60%) and 75% self-identified as gay. Half of the sample (n=10) reported currently taking PrEP for HIV prevention at the time of the interview.

Overall, the response to the original product descriptions (see Table 2) was positive. Participants reported having a better working knowledge of the products as compared to before reading the descriptions. However, four major themes for improvement were identified in the cognitive interviews: 1) scientific or medical terms; 2) reference to other, more established products; 3) clarity and redundancy; and 4) imagery suggestions. We used this feedback to finalize our product descriptions. The final descriptions (see Table 2) were slightly longer (average length increased from 67.4 words to 86.2 words), yet, maintained a consistent reading level (Flesch-Kincaid level 12.6 and 12.8 before and after modifications, respectively).

Terms and phrases to describe scientific and medical procedures

Across modalities, participants commented that the descriptions felt too “clinical” or “technical” and would prefer that they read more “personal or almost casual”. Other participants noted that it was important to use both “layman’s terms” and “scientific terms” to balance individual preferences for “technical” or “casual” language. To strike an adequate balance between scientific accuracy and accessibility to a broad audience, we made changes that included using the scientific term (e.g., rectum) and subsequently describing it with a less technical term (e.g., butt). In other instances, participants prioritized the use of casual language. For example, for the bnAbs description, some participants did not understand what “intravenous” meant even with the included explanation (“that is, a slow ‘drip’ of a medicine made from these antibodies into the veins”). They felt that using “IV” instead of or with “intravenous” would help clarify because, as one participant noted, “that’s the term everybody uses.” Similarly, terms and phrases such as “well-tolerated” (bnAbs), “expelled,” and “applicator” (rectal douches) were also perceived as unknown or confusing. Therefore, we substituted or eliminated these words in further iterations of the description.

In addition to revising technical language to provide more clarity, participants also felt that using more technical or scientific language could induce unnecessary fear or apprehension. For example, for the oral PrEP products (e.g., daily and on-demand), the original descriptions described the need to have follow up care with a PrEP provider every 3 months, and it was specified that this was for HIV/STI testing and to check kidney function. First, participants asked for clarifications as to whether all modalities, including the long-acting products, would require these periodic visits to the clinic; given that regardless of product, periodic testing will likely be recommended, we included reference to this visit in the revised descriptions of all products. Additionally, some participants felt that specifying the need to check for kidney function, without providing more details on this potential side effect, would create more worry and potentially more questions than necessary (particularly given that risk of kidney-related side effects is uncommon). Rather, for the purpose of a brief product description, participants described a preference for referring to this more generally as “blood work”. Similarly, the original description of bnAbs mentioned positive results in animal (i.e., monkey) models, which raised concerns about safety of the product and animal testing. For example, as one participant noted:

The part that really kind of freaks me out, though, is, like, it’s got tested on monkeys before. And, um, a-although in studies, it may show that there’s not really any type of distolerance…Just doesn’t make me feel validated by the fact that it’s been tested on animals. Like, I know a lot of medications get tested on animals, but I don’t want to know about that.

Reference to other products

For products that would be delivered through common routes of administration, participants also suggested comparing it to other medical interventions that are used more routinely in their own or their peers’ lives. For example, intramuscular injections for delivering injectable PrEP could be compared to “a flu shot or another sort of vaccination” or hormone injections. For products using less traditional modes of delivery (e.g., subcutaneous implants and rectal douches), participants acknowledged that others might be unfamiliar with these modes to deliver drugs into the body. As one participant noted, “a lot of people don’t know that you can even get medicine like that pretty effectively”, which hindered their understanding of the descriptions of these next generation HIV prevention modalities. In these instances, participants suggested including references to other products delivered through the same mode so that the methods sound less “speculative” or “science fiction-y.” For example, one participant, when commenting on the subcutaneous implant, stated:

For something that might seem weird to some people, I wonder if it’d be comforting to know what kind of, um, precedent exists. So is this like just like the technology that’s used for birth control implants? Um, ‘cause that way people might feel more comfortable with it and like if they know someone who’s like on a birth control implant.

Clarity and redundancy

Participants suggested additional revisions to reduce redundancy and improve clarity. For example, for on-demand PrEP, the original description described the timing of taking PrEP in a very detailed way (e.g.. “taken as two pills between 2 and 24 hours before a condomless sex encounter, followed by another pill 24 hours after condomless anal sex and another pill 24 hours after that”). Many participants felt that this level of detail was confusing and unnecessary for this purpose and rather it should be simplified to say “around the time of sex”.

Conversely, for other descriptions, participants wanted more details to better understand the products. For example, some participants believed that not all YMSM knew what a rectal douche was, which we addressed with the inclusion of “a douche uses a solution to clean the rectum before receptive anal sex (bottoming)” in the revised description. Moreover, some participants were uncertain, based on the descriptions, about who would be protected from HIV transmission. As one participant asked, “if one partner takes it, they’re [both] protected against HIV…[or] if both partners have to take this [the douche]?” To address these concerns, we specified in the revised description that only the receptive partner would be protected by the rectal douche.

In certain cases, in using everyday objects to describe the products, participants felt that more ambiguity was created. For example, to present subcutaneous implants, we described them as “matchstick-sized.” As one participant pointed out,

There are different sized matchsticks. So I guess depending on that…maybe a picture, you know, showing the actual size might help. Just because I know, for example, like, there are kitchen-sized matches that are, you know, very long. Whereas there are, you know, very, you know, pretty short ones, like the size of an inch and a half, or so…for somebody that might be on the fence about it because they’re uncomfortable with the idea, that might influence their decision if they knew the actual size.

As a result, the revised description specifies that implants are about 1.5 inches in length.

Imagery suggestions

The suggestions to use images came up both inductively and deductively. As described above, for modalities that participants were less familiar with as part of their regular medical care experiences (e.g., rectal douches, implantable devices), images were suggested as a way to make description of modalities more palpable and easier to “visualize”, which would be “difficult to do with [only] words.” For example, images of a subcutaneous implant would inform about the size of the device and where it would be implanted, and images of douche equipment would be informative for individuals not familiarized with the practice. As one participant stated, “having a picture of an enema or an applicator on the screen would be pretty useful, just so they know what they’re doing. Or like what may go up their butt.”

In addition to showing what next generation HIV prevention products are likely to look like, participants suggested using images to provide insights into the experience of using such products. For example, some participants suggested using images of a calendar to illustrate that on-demand oral PrEP would be taken over three days and not only before a sexual encounter. As one participant described:

At first, it was kind of difficult to wrap my mind around, like, be-taking four pills at once…I think an image, like an image of showing, like, you should do two right now, one right now, then one right now. I think that would be even more clear, probably.

DISCUSSION

To date, research on preferences and acceptability of next generation PrEP modalities has largely overlooked the perspectives of YMSM. The goal of this study was to evaluate comprehension of next generation PrEP modalities among YMSM and refine product descriptions. Through cognitive interviews, YMSM in our study offered recommendations to increase the comprehension of next generation HIV prevention product descriptions. Four areas for refinement were highlighted: scientific or medical terms; reference to other, more established products; clarity and redundancy; and image suggestions. Using PrEP product descriptions informed by YMSM perspectives may improve comprehension, as well as address concerns about medical mistrust and stigma associated with PrEP. The refined descriptions serve as exemplar text that may be used in future studies examining YMSM’s acceptability and preferences across these biomedical HIV prevention modalities.

YMSM in our study recommended fewer scientific or medical terms in descriptions of next generation PrEP modalities to improve understanding and reduce fear and apprehension. Previous research evaluating PrEP message comprehension has demonstrated that using paraphrases or a “gist” approach was preferred to describe HIV risk and PrEP efficacy (28, 29). A “gist” approach that is general and qualitative was associated with improved comprehension of HIV risk and motivation to use PrEP (29). It is noteworthy that the use of scientific or medical terms induced fear and apprehension among study participants. Medical mistrust may be a driver of decreased PrEP uptake among YMSM (30), which may be perpetuated in next generation PrEP modalities if product descriptions elicit feelings of fear and apprehension. A qualitative study evaluating acceptability of a mobile app to increase PrEP use among YMSM found diverging preferences for formal language that is more trustworthy, as well as casual language that is relatable and less anxiety producing (31). YMSM likely have a range of experience and comfort engaging in clinical care or interpreting information about prescription medications. As communication strategies are being developed for next generation PrEP modalities it will be necessary to balance accuracy with the need to motivate YMSM to engage in PrEP care.

Study findings may also provide strategies to reduce stigma associated with PrEP among YMSM. Participants reported that not all YMSM may be familiar with modes of delivery, and that references to other products may increase comfort with next generation PrEP modalities. Product descriptions were revised to describe the use of rectal douches, clarify intermittent PrEP as used “around the time of when you are planning to have sex”, and compare PrEP implants with contraception. PrEP messaging that targets sexual behavior will not reach individuals who are not comfortable with their sexuality (32), which may be more common among YMSM with emerging sexual identities. Situating next generation PrEP modalities within the context of sexual health, rather than risk behaviors may address PrEP stigma and improve uptake among YMSM (12, 33).

The current study provides important insights into incorporating YMSM perspectives into descriptions of next generation PrEP modalities that may have relevance to other populations. Accurate knowledge about PrEP has been shown to be low among people who use drugs, and including people who use drugs in the dissemination of information about next generation PrEP modalities may optimize use (34). For example, patterns of drug use may frame preferences for next generation PrEP modalities, such as timing intermittent PrEP with sexualized recreational drug use (35). Certain next generation PrEP modalities are formulated for specific populations, such as the Dapivirine ring for HIV prevention among women. Previous research on PrEP messaging for women emphasized PrEP as a prevention method usable without a partner’s knowledge (36). Incorporating women’s perspectives into the implementation of the Dapivirine ring will be important to increase uptake and acceptability.

Our study had limitations that should be considered. Although we achieved diversity of race and ethnicity as well as in PrEP experience, our study included few individuals under 18 years old, and as such we were not able to examine specific comprehension challenges among this vulnerable group of YMSM. Previous studies have shown that YMSM under 18 years old have similar understanding of information about clinical trials of daily oral and next generation PrEP compared to YMSM over 18 (17). However, whether there are differences in comprehension of information about PrEP products presented in the context of clinical care is unclear. Future studies should further evaluate our improved descriptions for YMSM at different developmental stages. Moreover, all participants were recruited from two urban areas in the US northeast, which may limit the generalizability of the findings. However, almost all study participants had previous experience with HIV prevention services, had previously heard about PrEP, and had condomless anal sex in the past six months, which allowed for informed perspectives on next generation PrEP modalities. Additionally, the study was limited to individuals who could understand and speak English. Future studies should examine comprehension of next generation PrEP modalities among non-English speaking populations. Most participants had a high school level education or higher, and the reading level of the product descriptions was not evaluated. We did develop imagery to improve comprehension of next generation PrEP modalities, and future studies may examine other methods accessible to populations with low literacy such as video. Lastly, this study focused on improving content validity of the descriptions based on cognitive interviews with 20 YMSM. Future studies should use these descriptions in larger quantitative assessments.

CONCLUSIONS

YMSM are at increased risk of HIV infection but are less likely to be prescribed PrEP (4, 6). Comprehensible, culturally-appropriate descriptions of next generation PrEP products are necessary to strengthen measurement accuracy, generate valid data on YMSM’s preferences and acceptability across next generation PrEP modalities, and increase comparability and generalizability of findings across studies. Accurate descriptions may also help to address gaps in the understanding of investigational products among participants in research on next generation PrEP products (17, 23, 37). Moreover, these descriptions can help advance product marketing and roll-out as these products become approved for use in real-world settings and may ultimately contribute to connecting YMSM to HIV prevention care.