Abstract
This mixed-methods study explored willingness to use long-acting injectable pre-exposure prophylaxis (LAI-PrEP) among a pharmacy-based sample of men, including sexual and gender minoritized (SGM) individuals. We conducted qualitative interviews (n = 10) with HIV-negative Black men, including Black SGM individuals, and surveys (n = 103) across three study phases with men recruited from community pharmacies in Atlanta, Georgia. Interviews explored perceived benefits and concerns related to LAI-PrEP; surveys assessed willingness and related reasons. Thematic analysis was used for interview transcripts, and descriptive statistics summarized survey responses. Participants mentioned benefits such as improved adherence and reduced stigma, but also noted concerns about medical mistrust and fear of needles. Willingness was higher in the transitional pilot phase than in the pilot phase, where concerns about side effects and comfort were more common. Findings highlight the need for tailored LAI-PrEP strategies that address barriers among Black SGM populations and promote equitable HIV prevention.
Keywords: PrEP, long-acting injectable, HIV, sexual minority men, transgender individuals
INTRODUCTION
The HIV epidemic in the United States (U.S.), especially the U.S. Southeast, continues to disproportionately burden Black sexual and gender minoritized (SGM) individuals, including men who have sex with men (MSM) and transgender individuals, particularly transwomen. Data from 2021 revealed that 67% of estimated new HIV infections in the U.S. were among MSM, with 51% of these new infections occurring in the southern region (Centers for Disease Control and Prevention [CDC], 2023). Notably, Black MSM account for 37% of new infections among MSM (CDC, 2023) despite comprising only approximately 9% of the total U.S. MSM population.(Lieb et al., 2011). Additionally, while transgender individuals represented a smaller proportion of new HIV diagnoses (2%), the majority of these diagnoses were among Black transgender individuals, especially transgender women (CDC, 2021b). What’s more, 43% of new HIV diagnoses among transgender women occurred in the U.S. Southeast (CDC, 2021b; Clark et al., 2017), accentuating the region’s heightened vulnerability to transmission and mortality within this population (Wirtz et al., 2023).
The advent of daily, oral preexposure prophylaxis (PrEP) has made tremendous progress in HIV prevention since 2012, reducing the incidence of HIV among several key populations (Chou et al., 2023; O Murchu et al., 2022). However, the uptake of PrEP among Black individuals, including MSM and transgender individuals, has been notably slower than that of their White counterparts (Eaton et al., 2017). CDC data show that the number of White people administered PrEP was almost five times greater than the number of Black people in 2019, despite estimates that Black adults made up approximately 40% of those with indications for PrEP (CDC, 2021a). More recently, in 2022, only 13% of Black people who could benefit from using PrEP obtained a prescription, as opposed to 94% of White and 24% of Hispanic/Latino people (Fanfair & Mermin, 2024). Moreover, Black people who use PrEP have lower adherence rates and are less likely to remain on PrEP during periods of HIV exposure compared to other racial and ethnic groups (Marcus et al., 2016).
Multiple systemic factors drive these inequities, including racism, stigma, discrimination, a history of medical mistrust, public policies such as HIV criminalization or a lack of Medicaid expansion, and limited access to PrEP-prescribing providers (Bonett et al., 2020; Cahill et al., 2017; Carneiro et al., 2022; Mayer et al., 2020; Siegler et al., 2019). Higher concerns regarding side effects, medication interactions, and daily oral dosing regimens have also emerged as significant barriers to PrEP use, specifically for Black compared to White MSM and transgender individuals (Mayer et al., 2020).
The recent approval of long-acting injectable (LAI) PrEP, the first injectable medication for HIV prevention, represents a promising advancement in the effort to combat the HIV epidemic, particularly within Black communities as it helps overcome some issues of adherence and access (Goedel et al., 2019; Maloney et al., 2021; Marshall et al., 2018). LAI-PrEP requires two initial injections administered one month apart, followed by injections every two months thereafter (Food and Drug Administration, 2021). Clinical trials have demonstrated the superiority of LAI-PrEP over daily oral PrEP in preventing HIV infections among sexual and gender minoritized individuals (Landovitz et al., 2021). If implemented equitably, LAI-PrEP has the potential to mitigate established barriers to HIV prevention in the U.S., including negative attitudes, beliefs, and discrimination associated taking a daily pill for HIV prevention (i.e., PrEP-related stigma), as well as adherence challenges (Jolayemi et al., 2022; Maloney et al., 2021; Marshall et al., 2018; Sharfstein et al., 2022; Shrestha et al., 2020). Indeed, previous studies show a high willingness to utilize LAI-PrEP among groups who report high levels of PrEP-related stigma, with 67% to 81% of study participants, including young and Black or Hispanic MSM, expressing interest (Levy et al., 2017; Mansergh et al., 2021; Meyers et al., 2014). However, these studies predominantly featured randomized clinical trials in which racially minoritized groups, such as Black individuals, are often underrepresented (Levy et al., 2017; Mansergh et al., 2021; Meyers et al., 2014; Okafor et al., 2024; Tolley et al., 2020; Turner et al., 2022). This underrepresentation compromises the generalizability of clinical research findings (National Academies of Sciences, Engineering, and Medicine et al., 2022). Therefore, it is crucial to conduct further research among minoritized populations, including Black SGM communities, who are disproportionately affected by HIV, to ensure comprehensive and equitable assessment.
Furthermore, despite high receptivity to LAI-PrEP, the few qualitative studies that have assessed willingness to use it, particularly in minoritized populations, have either focused on individuals involved in the criminal legal system, been conducted outside the U.S. South, or did not include transgender individuals (Jones et al., 2022; Patel et al., 2018; Tran et al., 2022). Notably, there is limited research in this area specifically among Black MSM and transgender individuals residing in Atlanta, GA, which ranks third in HIV diagnosis rates in the nation (Gaines, 2024). Consequently, critical gaps persist in understanding the potential barriers and facilitators of LAI-PrEP uptake among Black MSM and transgender individuals in the U.S. southeast region, including Atlanta.
To this end, this study utilized a mixed-methods approach to qualitatively characterize and examine willingness to use LAI-PrEP among self-reported HIV-negative Black MSM and transgender persons in the U.S. South, and quantitatively understand willingness to use LAI-PrEP among a convenience sample of men visiting community pharmacies. Participants were recruited from referrals through a community partner and community pharmacies in Atlanta, GA, as part of a larger study examining strategies for PrEP implementation in pharmacy-based settings (Crawford et al., 2022). Given the pivotal role of pharmacies in reaching at-risk communities (Crawford, Myers, et al., 2021). particularly those understudied, such as Black MSM and transgender individuals (Alohan et al., 2023; Crawford, Albarran, et al., 2021; Harrington et al., 2023), this research fills a crucial knowledge gap.
METHODS
STUDY DESIGN
The data included in this analysis were obtained from a larger, parent study, PrEP Up Pharmacies (PrEP UP), which aims to develop a culturally appropriate, pharmacy-based PrEP delivery model for Black MSM in underserved neighborhoods. The full protocol for the parent study has been described elsewhere (Crawford et al., 2022). Both the parent study and this analysis were guided by the Systems Engineering Initiative for Patient Safety (SEIPS), a multilevel framework that examines how work system components (e.g., personnel, tasks, organization, and pharmacy environment) influence healthcare processes and outcomes (Carayon et al., 2006). SEIPS informed the sequencing of study phases and the development of qualitative areas of focus and quantitative measures used to explore system- and individual-level factors affecting PrEP delivery and uptake in pharmacies.
Aligned with SEIPS’ focus on system interactions, the study followed an exploratory sequential mixed methods design, where qualitative findings from the formative phase informed subsequent study phases. Qualitative interviews with Black SGM individuals on barriers and facilitators to pharmacy-based HIV prevention services, including their willingness to obtain LAI-PrEP, shaped the design and content of surveys used in the transitional and pilot phases. The transitional pilot phase, conducted during the height of the COVID-19 pandemic, assessed characteristics of the pharmacy client population, while the pilot phase captured socio-behavioral data and PrEP eligibility. To our knowledge, there was no overlap between participants in qualitative and quantitative studies. All participants provided informed consent prior to participation in interviews or surveys.
All study procedures and methods were carried out in accordance with relevant guidelines and regulations and approved by the Institutional Review Board at Emory University.
QUALITATIVE STUDY
Participants and Recruitment.
The recruitment and data collection procedures took place between July and September 2019. Ten participants (N = 10) were recruited in collaboration with a community-based organization serving Black SGM in Atlanta, Georgia. Eligible participants had to (1) be at least 18 years old, (2) self-identify as a cisgender man or as a transgender or nonbinary individual, (3) identify as Black/African-American, and (4) be willing to share personal information on sexual behaviors.
Data Collection and Interview Guides.
During in-depth interviews (IDIs), participants were asked open-ended questions about their experiences with PrEP, including their preferences for receiving it in its various modalities. To assess participants’ willingness to use LAI-PrEP specifically, they were asked to respond to the following prompt and question: “In the future, PrEP may be offered in an injectable form and provide protection for a longer period than the pill form of PrEP. Would you be willing to receive an injectable form of PrEP for longer protection against HIV?”
Qualitative Analysis.
Researchers with master’s-level training in public health and qualitative research methods transcribed the audio-recorded interviews verbatim. MAXQDA Analytics Pro (VERBI Software, 2018), a qualitative data analysis software, was used to analyze participants’ interviews. DA, a cisgender Black gay man with a history of PrEP use, and CC, a cisgender Asian American heterosexual woman, employed a thematic approach (Maguire & Delahunt, 2017). DA and CC utilized code lists that were developed inductively from the literature and deductively from the research objective. DA and CC initially analyzed three transcripts and subsequently met to discuss emergent themes and to develop a codebook, which included inductive codes, definitions, and in-text examples. This codebook was then applied to code the remaining transcripts and generate findings. For the current study, DA and CC identified key themes, which were later corroborated with the senior author (NC).
QUANTITATIVE STUDY
Participants and Recruitment.
Recruitment for the transitional pilot phase and pilot phases of PrEP UP have been described elsewhere (Crawford et al., 2022). Eligibility criteria were slightly different for the transitional pilot phase and pilot phases. In the transitional pilot phase, clients were eligible for the social and behavioral survey if they were 18 years and older and: (1) self-identified as male or a transgender man; (2) had any type of sex (e.g., anal or oral sex) in the past 6 months; (3) engaged in condomless sex in the past 6 months; or (4) injected any drugs in the past 6 months. In the pilot phase, pharmacy clients were eligible for the study if they were 18 years and older and: had any type of sex in the past 6 months or engaged in unprotective sex in the past 6 months. Although women were eligible for the pilot phase based on behavioral indications, we restricted this analysis to cisgender men, transgender individuals, and participants who had no indication of currently living with HIV (e.g., noted they have tested positive for HIV previously or currently taking antiretrovirals).
Data Collection and Measures.
In the surveys for the transitional pilot and pilot phases of the study, participants were asked about their agreement to the statement, “I would take injectable PrEP if it were made available to the public” along a five-point scale of strongly agree to strongly disagree. Those who strongly agreed or agreed with the statement were categorized as willing to take LAI-PrEP, and those who disagreed or strongly disagreed were categorized as unwilling to take LAI-PrEP. Participants who answered “neutral” were categorized as neutral to being willing to take LAI-PrEP. Those who were either willing or unwilling to take LAI-PrEP were subsequently asked to check all that apply among a list of reasons for being willing and unwilling to take LAI-PrEP: cost, time, side effects, safety, personal comfort level, and privacy. There was an option to choose “other” and write in a reason for willingness or unwillingness to take LAI-PrEP. Sociodemographic data, including age, race, ethnicity, income, and insurance coverage were collected.
Quantitative Analysis.
We described the number and proportion of participants answering whether they were willing or unwilling to take LAI-PrEP as well as the characteristics of study participants by their willingness to take LAI-PrEP. We also presented number and proportion of participants who selected the listed reasons behind their willingness to take LAI-PrEP. Results for the transitional pilot and pilot phase were presented separately since LAI-PrEP had not yet been approved by the FDA during the transitional pilot phase but had already been approved during the pilot phase. All analyses were conducted in R statistical software (v4.3.2; R Core Team, 2022).
RESULTS
Table 1 summarizes the rounds of data collection, recruitment, and data collected from each phase of the study related to LAI-PrEP. The study was conducted in three distinct phases: the formative phase (April 2017–December 2018), the transitional pilot phase (February 2021), and the pilot phase (June 2022–May 2023). During the formative phase, data from 10 participants (8 cisgender men, 1 transgender man, and 1 transgender women) were collected and analyzed. In the transitional pilot phase, 80 participants were recruited from two community pharmacies in low-income, underserved areas of Atlanta with high HIV prevalence. Data from 73 participants were analyzed, assessing their willingness to take LAI-PrEP and their reasons for being wiling or unwilling. The pilot phase involved data from 29 cisgender men, with a similar focus to the transitional pilot phase.
Table 1.
Summary of data collection efforts from mixed methods PrEP UP study, 2017–2023
| Formative Phase (Qualitative) | Transitional Pilot Phase (Quantitative) | Pilot Phase (Quantitative) | |
|---|---|---|---|
| Data collection period | April 2017 – December 2018 | February 2021 | June 2022 – May 2023 |
| Recruitment sites | Referrals through community partners who provide HIV prevention services to MSM | Two community pharmacies in low-income, underserved Atlanta communities with high HIV prevalence | One community pharmacy also participating in the transitional pilot phase |
| Total study participants | 12 | 80 | 49 |
| Participants included in analysis (restricted to men and transgender individuals) | 10 (8 cisgender men, 1 transgender man, 1 transgender woman) |
73 (72 cisgender men, 1 transgender man) |
29 (all cisgender men) |
| Relevant data collected | Willingness to use LAI-PrEP (open-ended discussion) | Willingness to take LAI-PrEP and reasons for being willing or unwilling to take LAI-PrEP | Willingness to take LAI-PrEP and reasons for being willing or unwilling to take LAI-PrEP |
QUALITATIVE RESULTS
Sample Characteristics.
Participants’ ages ranged between 19 and 28 years old, with the majority of participants self-identifying as Black cisgender MSM (8; 80%). Two self-identifying transgender individuals also participated in the study. Of the ten participants, six (60%) were willing to use LAI-PrEP.
Emergent Themes Among Willing Participants.
We identified three major themes among participants willing to use LAI-PrEP. These themes were as follows: (1) improved medical adherence and convenience, (2) reduced HIV/PrEP-related stigma, and (3) general preferences for injectable vs. pills. Within some of the themes, we identified several subthemes related to participants’ willingness to use LAI-PrEP, which we describe below.
THEME 1: IMPROVES MEDICAL ADHERENCE AND CONVENIENCE.
Several participants felt that taking LAI-PrEP would improve both behavioral and biological outcomes related to HIV prevention.
Adherence.
One participant discussed LAI-PrEP as an opportunity to improve adherence by reducing the number of doses required to build up protection against HIV, as described below:
Absolutely, I think it’s an amazing addition and advancement in, you know, health. I think it would definitely help with adherence, people have mishaps day to day, and you don’t wait to build up resistance by missing a dosage. Having an injectable where they might have to come back every 2 to 3 months or something like that so it would be amazing, and they would not miss any doses. They would come in to get their shot and they are good to go. (P3, cisgender man)
Another participant described this phenomenon, comparing it explicitly to oral PrEP:
Um, I would say “yeah” because um people are forgetful and people um a lot of people operate off of routine so if you don’t have to take a medication every day, um there is a possibility you can go days or weeks without taking it versus if it’s already in your system, you can easily you know go back to a doctor. (P1, cisgender man)
Convenience.
Several participants discussed the convenience of utilizing LAI-PrEP compared to the pill, as they would not have to worry about whether or not they had taken it on a single day.
Interestingly, one participant described their willingness to use LAI-PrEP as an opportunity to enhance adherence due to how it is administered. Critically, this participant related their experience taking injectable hormones to the potential benefits of LAI-PrEP.
To be honest, I really do hope that the clinic study that they’re doing is approved because having an injection versus pills every day is definitely—to me it’s better because you don’t worry about having to take a pill—especially a person that has taken hormones every day, I think it’s the same thing. I have to take this every day to make sure this drug of protection, or prevention, or whatever you know is staying strong in my body and I have to keep taking the hormones to make sure that the womanly side stays present (haha). So even then with hormones, eventually you want to stop taking the pills and you want to take the shot because it’s more effective—not to say it’s the same with PrEP where one is more effective than the other, I just think it’s a convenient thing … Yeah and you know it hits your bloodstream faster, and I feel like it’s safe for your kidneys and stuff because—I don’t know for sure but I think it’s because it’s not necessarily being broken down and processed through the kidneys and stuff like a pill would, but I’m not sure. But I feel like it’s hitting your bloodstream faster and it lasts longer too. (P5, transgender woman)
Similarly, another participant related LAI-PrEP to the flu shot, as an opportunity to promote longer protection and reduce forgetfulness around possibly not taking oral PrEP:
Yes, I feel like that would be a lot more easier because in my medical experience, some people don’t like taking pills every day. A lot of people, it’s easier for them to get a flu shot you know so it’s like people are forgetful to take a pill everyday. Um, it’s just more convenient to take that shot and be able to set an appointment to take that next shot versus every day you have to wake up same time to take this pill in order for it to be super effective. You have to keep a schedule on it, you have to keep a “Oh, did I take it today, did I not.” (P10, cisgender man)
THEME 2: REDUCING HIV-RELATED STIGMA
One participant mentioned that LAI-PrEP offers individuals more privacy around their sexual health, reducing potential harms that might be associated with taking oral PrEP:
And it’s a lot more discreet because what if you’re out and about at the time that you have to take you specific pill, no matter what pill it is, just pills in general, you don’t want everybody to be knowing that you take a pill. “What pill is that?” you know or what if you were doing something and you don’t know you dropped the pills and someone comes behind you and looks at the pills like “Oh, that’s what that is for.” You know it’s just a lot more easier and discreet for you to take a shot and then boom come back in a couple months for your next dose. It’s easier because now you can go about your life more better and a lot more normal because if you take a pill a day, you won’t feel normal. (P10, cisgender man)
THEME 3: GENERAL PREFERENCES FOR INJECTABLES VS. PILLS
Several participants had a general affinity for injectables as opposed to taking pills daily.bFor example, one participant explained:
I would prefer that rather than pills because I’m good with shots, I don’t know why, but I like shots better than pills, because pills I have keep up with every day and swallowing pills isn’t my thing. (P4, cisgender man)
In another instance, one participant, while they generally did not like engaging in traditional medicine, was still willing to use injectable PrEP compared with its counterpart:
Yes definitely, hell yeah, yeah. … I don’t like taking the pill every day, I didn’t like taking [oral PrEP] every day, um I don’t like taking medicine even when I get a cold, so it’s, I didn’t want to take the medicine. I can do a shot. (P5, cisgender man)
EMERGENT THEMES AMONG UNWILLING PARTICIPANTS
While some participants were willing to use PrEP, others were not willing to do so. Among these participants, we identified three major themes. These themes included (1) medical skepticism, (2) trypanophobia—the fear of needles, and (3) limited sexual autonomy. We also discovered two subthemes within the medical skepticism theme regarding some participants’ unwillingness to use LAI-PrEP.
THEME 1: MEDICAL SKEPTICISM
Some participants reported a lack of trust in or suspicion of medical institutions, as well as the efficacy of vaccines.
Legacy of Medical Racism.
One participant explicitly described their apprehensions toward utilizing LAI-PrEP in the context of their understanding of the medical mistreatment of Black people:
I think that goes back to the mistrust among the medical community. It’s really reminiscent of the Tuskegee experiment for me. Yeah, like the needles are just like—I don’t really even like giving myself my shot. It’s just like touchy for me. (P9, transgender man)
Treatment Efficacy.
Another participant was unwilling to use LAI-PrEP because they were uncertain about its effectiveness, as they had previous negative experiences with vaccinations for other illnesses:
Like for instance I’m [not] big on needles, right, but like the flu for instance the flu [shot] is supposed to protect you from the flu, but for years it has not done that for me. Every time I take the flu shot, in like a couple of weeks later I get the flu. I don’t really trust injections like that. I would prefer the pill; I would much rather prefer the pill. (P6, cisgender male)
Similarly, another participant was skeptical about the effectiveness of PrEP but also had a general aversion to needles:
No, I wouldn’t be comfortable with that … Because I just … first of all, I don’t trust needles. I don’t like needles, and then even if I do get it injected and it lasts longer, no matter what I could still take the pills or whatever and it would still do the same thing. It’s just going to last longer. I’d rather take the pills than get it injected inside of me, because, that could mess up something and I wouldn’t know. Like they would say, “Okay, it’s safe or whatever,” but what if something happens? You never know what’s going to happen if you’re injected with something. Just like if you take pills, you never know what’s the [side effects]. (P7, cisgender man)
THEME 2: PRIOR INJECTING EXPERIENCE
Some participants, such as Participant 6 above, had a history of using needles to address medical conditions, and this history indicated their unwillingness to use LAI-PrEP, as mentioned below:
I don’t really like shooting myself when I used to be a diabetic, so I don’t want to shoot myself for anything else and that was probably the worst, so. (P8, cisgender man)
THEME 3: MEDICAL REMINDER
In addition to generally being needle averse and uncertain about the effectiveness of LAI-PrEP, Participant 7 also mentioned that they preferred oral PrEP to LAI-PrEP because it would serve, in some way, as a medical reminder to engage in daily HIV prevention activities:
I would be more comfortable with taking a pill than having it inject, because it would help me every day to “Okay, I got to take a pill? … I got to go back and get some more on this day and this day.” If I get injected, I going to forget about it and be like, “Oh, snap I got to go!” (P7, cisgender man)
QUANTITATIVE RESULTS
Study participants who identified as a male (n = 72) or transgender man (n = 1) in the transitional pilot phase were younger with a mean age of 30.0 years compared to male-identifying participants of the pilot phase (n = 29), who had a mean age of 39.2 years (Table 2). There were no transgender individuals among pilot phase participants. Additionally, most transitional pilot phase participants were White (49.3%) or Hispanic (42.5%) compared with pilot phase participants who were mostly Black (86.2%) with no White participants. In the transitional pilot phase, more than half (63.0%) were willing to use LAI-PrEP. However, about one-third of participants in the transitional pilot phase (32.9%) and pilot phase (34.4%) were neutral about taking LAI-PrEP.
Table 2.
Characteristics of PrEP UP study participants identifying as male in the transitional pilot phase and pilot phases of the study
| Characteristic (N, % unless otherwise noted) | Transitional Pilot Phase, 2020–2021 | Pilot Phase, 2022–2023 |
|---|---|---|
| Total | 73 (100.0%) | 29 (100.0%) |
| Age (years; mean, SD) | 30.0 (3.3) | 39.2 (14.8) |
| Race and Ethnicity | ||
| Black | 2 (2.7%) | 25 (86.2%) |
| Hispanic | 31 (42.5%) | 1 (3.4%) |
| Native American, Alaskan, or Aleutian | 4 (5.5%) | 1 (3.4%) |
| White | 36 (49.3%) | 0 (0.0%) |
| Other | — | 2 (6.9%) |
| Income | ||
| $20,000 or less | 46 (63.0%) | 13 (44.8%) |
| Greater than $20,000 | 27 (37.0%) | 8 (27.6%) |
| Missing | — | 8 (27.6%) |
| Insurance coverage | ||
| No insurance | 22 (30.1%) | 17 (58.6%) |
| Medicaid | 15 (20.5%) | 3 (10.3%) |
| Private Insurance | 36 (49.3%) | 5 (17.2%) |
| Insurance, not specified | — | 3 (3.4%) |
| Missing | — | 1 (3.4%) |
| Ever taken PrEP | ||
| Yes | 50 (68.5%) | 1 (3.4%) |
| No | 18 (24.7%) | 25 (86.2%) |
| Missing | 5 (6.8%) | 3 (10.3%) |
| HIV risk perception | ||
| Perceived no risk | — | 3 (10.3%) |
| Neutral | — | 1 (3.4%) |
| Perceived some risk | — | 8 (27.6%) |
| Missing | — | 17 (58.6%) |
| Willingness to use LAI-PrEP | ||
| Willing | 46 (63.0%) | 6 (20.1%) |
| Neutral | 24 (32.9%) | 10 (34.4%) |
| Unwilling | 3 (4.1%) | 13 (44.8%) |
There were also differences between study phases when stratified by willingness to use LAI-PrEP. Across the transitional pilot and pilot phases, a higher proportion of those unwilling to take LAI-PrEP had no insurance coverage compared to those who were willing to take LAI-PrEP (66.7% vs. 41.3% and 76.9% vs. 66.7%, respectively; Table 3). While 80.4% of those willing and all of those unwilling to take LAI-PrEP in the transitional pilot phase had ever taken oral PrEP, only one (16.7%) of those willing to take LAI-PrEP in the pilot phase had ever taken PrEP, and no one unwilling to take LAI-PrEP in the pilot phase had ever taken oral PrEP. Additionally, all study participants with private insurance were either neutral or willing to take LAI-PrEP; those unwilling to take LAI-PrEP either had no insurance or Medicaid in both study phases. These participants also noted cost as the only reason they would be unwilling to use LAI-PrEP (Table 3).
Table 3.
Reasons for willingness or unwillingness to use LAI-PrEP by PrEP UP study phase period
| Willingness to use LAI-PrEP | ||||||
|---|---|---|---|---|---|---|
| Transitional Pilot Phase, 2021 (N=74) | Pilot Phase, 2022–2023 (N=29) | |||||
|
| ||||||
| Characteristic (N, % unless otherwise noted) | Willing (N=46) | Neutral (N=24) | Unwilling (N=3) | Willing (N=6) | Neutral (N=10) | Unwilling (N=13) |
| Age (mean, SD) | 30.1 (3.2) | 32.5 (4.7) | 30.7 (3.5) | 37.2 (13.2) | 35.8 (13.1) | 42.7 (16.8) |
| Race and Ethnicity | ||||||
| Black | 0 (0.0%) | 2 (8.3%) | 0 (0.0%) | 6 (100.0%) | 7 (70.0%) | 12 (92.3%) |
| Hispanic | 21 (45.7%) | 10 (41.7%) | 0 (0.0%) | 0 (0.0%) | 1 (10.0%) | 0 (0.0%) |
| Native American, Alaskan, or Aleutian | 3 (6.5%) | 1 (4.2%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (7.7%) |
| White | 22 (47.8%) | 11 (45.8%) | 3 (100.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Other | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (20.0%) | 0 (0.0%) |
| Income | ||||||
| $20,000 or less | 29 (63.0%) | 15 (62.5%) | 2 (66.7%) | 2 (33.3%) | 3 (30.0%) | 8 (61.5%) |
| Greater than $20,000 | 17 (40.0%) | 9 (37.5%) | 1 (33.3%) | 1 (16.7%) | 4 (40.0%) | 3 (23.1%) |
| Missing | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (50.0%) | 3 (30.0%) | 2 (15.4%) |
| Insurance coverage | ||||||
| No insurance | 19 (41.3%) | 1 (4.2%) | 2 (66.7%) | 4 (66.7%) | 3 (30.0%) | 10 (76.9%) |
| Medicaid | 8 (17.4%) | 6 (25.0%) | 1 (33.3%) | 1 (16.7%) | 0 (0.0%) | 2 (15.4%) |
| Private Insurance | 19 (41.3%) | 17 (70.8%) | 0 (0.0%) | 1 (16.7%) | 4 (40.0%) | 0 (0.0%) |
| Insurance, not specified | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (30.0%) | 0 (0.0%) |
| Missing | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (7.8%) |
| Ever taken PrEP | ||||||
| Yes | 37 (80.4%) | 10 (41.7%) | 3 (100.0%) | 1 (16.7%) | 0 (0.0%) | 0 (0.0%) |
| No | 6 (13.0%) | 12 (50.0%) | 0 (0.0%) | 3 (50.0%) | 9 (90.0%) | 13 (100.0%) |
| Missing | 3 (6.5%) | 2 (8.3%) | 0 (0.0%) | 2 (33.3%) | 1 (10.0%) | 0 (0.0%) |
| HIV risk perception | ||||||
| Perceived no risk | — | — | — | 1 (16.7%) | 4 (40.0%) | 3 (23.1%) |
| Neutral | — | — | — | 0 (0.0%) | 1 (10.0%) | 0 (0.0%) |
| Perceived some risk | — | — | — | 0 (0.0%) | 0 (0.0%) | 3 (23.1) |
| Missing | — | — | — | 5 (83.3%) | 5 (50.0%) | 7 (53.8%) |
| Reasons willing or unwilling to use LAI-PrEP | ||||||
| Cost | 15 (32.6%) | — | 3 (100.0%) | 2 (33.3%) | — | 1 (7.7%) |
| Time | 21 (45.7%) | — | 0 (0.0%) | 3 (50.0%) | — | 0 (0.0%) |
| Side effects | 12 (26.1%) | — | 0 (0.0%) | 1 (16.7%) | — | 5 (38.5%) |
| Safety | 27 (58.7%) | — | 0 (0.0%) | 3 (50.0%) | — | 2 (15.4%) |
| Personal comfort level | 13 (28.3%) | — | 0 (0.0%) | 2 (33.3%) | — | 5 (38.5%) |
| Privacy | 12 (26.1%) | — | 0 (0.0%) | 2 (33.3%) | — | 3 (23.1%) |
| Other - doesn’t like injections a | — | — | — | — | — | 1 (7.7%) |
Write-in answer from the pilot phase social behavioral survey
In the transitional pilot phase, safety (58.7%) was the most common reason among participants willing to take LAI-PrEP (n = 46), followed by time (45.7%), and cost (32.6%; Table 3). In the pilot phase of the study, among those willing to take LAI-PrEP (n = 6), safety and time were the most common reasons (50.0% for each), followed by cost, personal comfort level, and privacy (33.3% for each). Among those unwilling to take LAI-PrEP in the pilot phase (n = 13), side effects (38.5%) and personal comfort level (38.5%) were the most common reasons for being unwilling to take LAI-PrEP, followed by privacy (23.1%). One participant noted that they don’t like injections in a write-in answer for being unwilling to take LAI-PrEP, like some of the qualitative findings in the formative phase of the study.
DISCUSSION
The main goal of this study was to investigate willingness to use LAI-PrEP among a pharmacy-based sample of men, including Black SGM individuals residing in the U.S. Southeast, before and after FDA approval. Importantly, we identified barriers to and facilitators of potential LAI-PrEP adoption within this population. Such insights could inform the development of future implementation strategies aimed at fostering health equity in HIV prevention efforts. The rationale behind participants’ willingness to utilize LAI-PrEP exhibited considerable diversity, with their decisions largely contextualized within the broader spectrum of personal and communal considerations. Our thematic analysis identified multiple potential drivers of (un)willingness to utilize LAI-PrEP, including medical adherence, convenience, discomfort with needles/injections, mitigation of PrEP-related stigma, and a palpable sense of medical apprehension engendered by systemic anti-Black violence (Dumas & ross, 2016; ross, 2020) as well as general mistrust. Quantitative results similarly suggested the importance of personal comfort, side effects, and privacy in unwillingness to use LAI-PrEP in a study group of predominantly Black men (pilot phase) compared to a study group that had few Black men (transitional pilot phase). The varying nature of participants’ responses underscores the importance of providing prospective PrEP users with a menu of options, whether oral or LAI formulations, tailored to align with their lifestyle needs at the point of administration.
Our findings echo those of previous research investigating LAI-PrEP, particularly concerning perceived treatment efficacy, PrEP-related stigma, and medical adherence (Azhar et al., 2021; Meyers et al., 2014; Tolley et al., 2020; Weeden et al., 2024). The theme of medical adherence and convenience emerged prominently among willing participants, aligning with literature on the benefits of long-acting formulations in promoting regimen adherence and reducing the burden of daily pill-taking (Kaplan et al., 2013; Rogers et al., 2023). Participants expressed enthusiasm for LAI-PrEP’s potential to mitigate adherence challenges associated with oral PrEP, citing the convenience of less frequent dosing schedules and the elimination of daily pill-taking routines. These findings underscore the critical importance of considering regimen preferences and lifestyle factors in PrEP delivery to optimize uptake and retention.
Furthermore, our study highlights the role of LAI-PrEP in addressing HIV-related stigma, particularly concerning the privacy and discretion afforded by injectable formulations. Participants expressed concerns about the visibility and social implications of oral PrEP use, emphasizing the appeal of a more discreet preventative option. This finding aligns with previous research underscoring the impact of stigma of PrEP uptake and adherence (Calabrese, 2020; Golub, 2018; Rosengren et al., 2021). Taken together, these studies suggest that LAI-PrEP may serve as a pathway to mitigate these barriers and promote engagement in HIV prevention among historically marginalized populations.
Conversely, unwilling participants expressed reservations rooted in medical skepticism and fear of needles, echoing concerns documented in prior research on injectable medications (Carillon et al., 2020; Kane et al., 2021). These apprehensions were compounded by broader issues of mistrust in medical institutions and the legacy of medical racism. Medical mistrust is a well-documented barrier to oral PrEP uptake that significantly impacts individuals’ ability to trust that a new, longer acting medication (i.e., LAI-PrEP) is safe and effective (Cahill et al., 2017). Moreover, medical mistrust may be particularly salient for Black people in the U.S., especially in the southeastern region, given the U.S.’s long history of medical racism and mistreatment, which often involved the use of injections (e.g., forced sterilization of Black women) (Nuriddin et al., 2020; Washington, 2006). This finding reflects the nuanced interplay of individuals, interpersonal, and structural factors shaping PrEP use behaviors. Addressing these barriers will require multifaceted interventions that address individual concerns (e.g., providing LAI-PrEP education) and systemic inequities to foster trust and facilitate informed decision-making around PrEP uptake.
Importantly, our study underscores the need for tailored approaches to PrEP implementation that recognize the diverse preferences and experiences of Black SGM communities. By offering a range of delivery modalities and addressing barriers to access and acceptability, healthcare providers can empower individuals to make informed choices about their HIV prevention strategies (Dubov et al., 2019; Maloney et al., 2021; Wulandari et al., 2022). However, the key differences in willingness and unwillingness in the transitional pilot phase and pilot phase of the study are likely a result of the different racial compositions of each study population. Without addressing the underlying contextual and cultural factors that impact Black men’s unwillingness to use LAI-PrEP, LAI-PrEP may continue to benefit those who have already historically been benefitting from daily oral PrEP (Marshall et al., 2018; Sharfstein et al., 2022), further contributing to inequities in PrEP uptake and new HIV infections. Future research should continue to explore the implications of LAI-PrEP for health equity and advance our understanding of the intersecting factors shaping PrEP uptake among this population.
Finally, the utilization of a community pharmacy sample for this study holds significant importance for several reasons. Community pharmacies serve as accessible and familiar healthcare settings for many individuals, offering opportunities for engagement with key populations at increased risk for HIV, including Black MSM and transgender individuals (Alohan et al., 2023; Crawford, Albarran, et al., 2021; Crawford et al., 2020, 2022) who have documented barriers to accessing traditional healthcare facilities (Brincks et al., 2019; Irvin et al., 2014; Quinn et al., 2019). The demographic differences in the convenience samples recruited at community pharmacies in the transitional pilot phase and pilot phase study show the diversity of populations that utilize pharmacies. By recruiting participants from community pharmacies, this study tapped into a diverse and understudied population in relation to LAI-PrEP. Moreover, community pharmacies play a crucial role in HIV prevention efforts, offering services such as HIV testing, counseling (Crawford, Myers, et al., 2021), and now, with the advent of LAI-PrEP, potentially dispensing long-acting HIV prevention medications. Therefore, understanding the willingness to adopt LAI-PrEP within the context of community pharmacies provides valuable insights into the feasibility and acceptability of implementing this innovative prevention tool within accessible and trusted healthcare settings.
LIMITATIONS
The findings from this study should be interpreted considering its limitations. First, our results are based on a small, convenience sample and cannot be generalized to all Black MSM and transgender women, especially those with limited access to pharmacies and other HIV-related services. Critically, only three transgender individuals were included in our study (two in the formative phase and one in the transitional pilot phase). More research including this population is necessary, given their unique experiences and elevated HIV risk, even compared to BSMM. Second, while the overall study was designed to center the experiences of Black SGM individuals, the TPP sample was predominately White. Consequently, caution should be exercised when interpretating the relevance of TPP findings for Black SGM communities. Third, data were collected at different times of importance. The formative and transitional pilot phases were conducted prior to the FDA’s approval of LAI-PrEP and prior to or during the initial push for the COVID-19 vaccines, while the pilot phase of the study was conducted after FDA approval and after mass COVID-19 vaccinations; thus, current contextual factors surrounding Black MSM and transgender individuals’ willingness’ to utilize this innovation may have been impacted. Fourth, the interview guide that facilitated conversations with participants did not provide a full description of the LAI-PrEP modality, thus potentially obscuring their full understanding of LAI-PrEP. Finally, the cross-sectional nature of how the data were collected limits our ability to assess whether individuals’ willingness to use LAI-PrEP results in their use of this prevention tool.
CONCLUSION
Despite these limitations, this study is among the first to assess the willingness and associated reasons to use LAI-PrEP among a pharmacy-based sample of Black people, with attention to SGM individuals. Our study suggest that HIV prevention services should be tailored to the unique needs of each individuals. Of note, multilevel approaches to address medical mistrust should be integrated in future HIV prevention efforts, especially those focused on reducing racial inequities, particularly among Black people in the U.S. Southeast. Moreover, with the recent approval of LAI-PrEP by the FDA, studies are urgently needed to examine its integration in community-based settings, such as pharmacies in high HIV and racially minoritized neighborhood, to reduce barriers to PrEP access and improve health equity.
Acknowledgments.
We thank study participants for their time in providing the study team with rich data about their experiences.
Funding statement.
This research was supported by the National Institute of Mental Health (R34 MH119007) and the National Institute of Drug Abuse (T32 DA050552). The results and opinions expressed therein represent those of the authors and do not necessarily reflect those of NIMH or NIDA.
Footnotes
Disclosure of conflicts of interests. The authors declare no conflicts of interest.
Contributor Information
Daniel I. Alohan, Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia
Christina Chandra, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.
Henry N. Young, Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, Georgia
Alvan Quamina, NAESM, Inc., Atlanta, Georgia.
David P. Holland, Mercy Care, Atlanta, Georgia
Natalie D. Crawford, Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia
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