The widespread introduction of pre-exposure prophylaxis (PrEP) to prevent HIV has been an important step in efforts to end the HIV epidemic in the United States.1 Although uptake in some populations has been growing, in the fourth quarter of 2017, the PrEP-to-need ratio for women (number of PrEP prescriptions divided by number of new HIV diagnoses) was less than a fourth of that of men (0.4 versus 2.1). This reflects a significant inequity in PrEP use among women compared with their need.2 Black cisgender women in particular are underrepresented among PrEP users, although they accounted for 11.5% of all new HIV infections in 2017, and have a 14.6-fold higher risk of acquiring HIV infection compared with white women.3 Work to date has found barriers along the PrEP care continuum for cisgender women, including difficulty identifying women who are the most likely to benefit from PrEP, low levels of PrEP knowledge, HIV and PrEP stigma, mistrust in the health care system, and self-reported barriers to PrEP initiation and adherence, such as substance abuse, intimate partner violence, and depression.4–11
Research into interventions to increase PrEP uptake and adherence in other disproportionately impacted groups, such as men of color who have sex with men and transgender women, is ongoing in many high burden areas in the United States.12,13 Approaches have targeted multiple steps along the PrEP continuum to address a range of barriers from knowledge to access.13,14 Despite ground-breaking work to increase PrEP awareness and uptake in Chicago, success in improving PrEP uptake among black cisgender women remains extremely low, with only 336 on PrEP in 2017.15,16 We designed a mixed-methods study that examined PrEP knowledge, attitudes, preferences, and experiences among PrEP-naive and PrEP-initiated cisgender women to identify preferred intervention and implementation strategies that can increase PrEP uptake.
Cross-Sectional Survey Sample and Design
We recruited nonpregnant, adult HIV-negative cisgender PrEP-naive women from the following 2 locations in Chicago: (1) a sexual health and sexually transmitted infection testing and treatment clinic [sexually transmitted infections (STI) clinic] run by the Chicago Department of Public Health located on the west side of Chicago and (2) the adult emergency department (ED) of an academic medical center located on the south side of Chicago. The neighborhoods served by these 2 sites are mostly people of color, with a high proportion of households living below the federal poverty line, and some of the highest HIV incidence rates in the city, including Washington Park and Chatham with rates of 55.8–88.7 per 100,000 in 2018.15 Pregnant women were excluded because the recommendations and decisions regarding PrEP use during pregnancy could be quite different from those for nonpregnant women, and subanalyses would not have been possible given the sample size.
Women were recruited by the research team in the site waiting rooms, and eligibility determined through the initial survey questions. In the ED, we preferentially recruited women presenting with a chief complaint of STI-related symptoms and women who had a positive STI test in the previous 6 months. Eligible women completed a self-administered tablet-based survey through REDCap.17 When available, we used published survey items on PrEP knowledge, attitudes, PrEP stigma,4 and access preferences, and when not available, we used surveys from other studies noted in the acknowledgments. We also asked about preferred sources for PrEP information, preferred locations to initiate and refill PrEP, and potential barriers or support needs. As needed, questions were adapted for relevance to cisgender women and to accommodate survey length constraints (Table 1). Additional questions included sociodemographic factors, health care access, HIV-risk behaviors in the past 6 months (eg, sexual activity and condom use), perceived HIV risk (zero to very large), worry about getting HIV (none of the time to all of the time), and activities to protect against HIV.7,8,18,19 PrEP eligibility was determined based on the 2017 US Public Health Services (USPHS) summary guidance criteria for PrEP described by Calabrese et al (see also Table 2).20,21 After asking about PrEP knowledge, PrEP was explained to elicit attitudes and preferences.
Focus Groups and Key Informant Interviews Study Population and Design
We conducted 2 focus groups (FGs) with PrEP-naive nonpregnant cisgender women aged 18 years or older (n = 16). We performed key informant interviews (KIIs) with nonpregnant cisgender women aged 18 years or older who had initiated PrEP. Our KII recruitment target was 10, but because of challenges identifying PrEP-experienced cisgender women, we were only able to complete interviews with 7. These participants were recruited through local community-based organizations that provided social and health services to women at risk of HIV and through clinical contacts of the study team.
The FG protocol was informed by a social ecological theory and designed to provide insights into survey responses and the multilevel factors that shape women's PrEP knowledge, attitudes, and preferences.22 The KII protocol used a semistructured protocol to understand women's pathways to PrEP use, facilitators of and barriers to PrEP uptake and adherence, and recommendations to increase PrEP access and uptake for cisgender women.
The study was approved by the Institutional Review Boards at Northwestern University, University of Chicago, and the Chicago Department of Public Health. All individuals provided informed consent before participating in the study, and if eligible were compensated for their participation. All individuals were also given PrEP educational materials at the end of their study encounter.
We created composite variables on perceived PrEP stigma (5 items) and effectiveness (3 items), both scored on a five-point strongly agree to strongly disagree scale, with higher scores representing better perceived effectiveness and lower stigma.7,18,23 We also created summation variables for correct responses to STIs that PrEP protects against (6 questions, score 0–6) and HIV knowledge (9 questions, score 0–9).
We analyzed the data in SAS 9.3 (SAS Institute, Inc., Cary, NC), reporting descriptive statistics, and results of bivariate analyses (including χ2 or Fisher exact tests and t tests). Factors significant at the P < 0.20 level in bivariate analyses were included in multivariable logistic regression models for PrEP awareness and likelihood to start PrEP in the next 6 months. We also included variables a priori based on known associations from the literature.
We developed an analytic codebook based on the FG and KII protocols, extant literature and field notes, and deidentified FG and KII transcripts in Dedoose for analysis.24 After the initial codebook was created, 2 independent coders analyzed an FG transcript, and 2 additional independent coders analyzed a KII transcript. All coders then met to compare results, establish coding norms, and refine the codebook. We also used open coding to identify emergent themes and invoked a negative incident analysis to identify divergent statements.25 Each coder then coded assigned transcripts independently, starting with broad coding and progressing to more focused coding. Codes were reviewed by a second coder with differences discussed until a consensus was reached by the coding team.26
We surveyed 370 women between April and August 2018, 120 (32.4%) from the STI clinic and 250 (67.6%) from the ED (Table 2). The median age was 28 years (range 18–57 years), and most (83.0%) identified as black, with one half (58.9%) having at least some college education (Table 2). Three-quarters (71.3%) had a regular source of health care (83.0% doctor's office or health center), and 61.9% had health insurance. Most (84.1%) reported vaginal or anal sex in the past 6 months, with low rates of consistent condom use (14.5% for vaginal sex and 19.2% for anal sex). Respondents reported low rates of partners known to be a high risk of HIV infection, transactional sex, or injection drug use. One-third had sex with >1 partner, and 11.6% reported testing positive for a bacterial STI in the previous 6 months. HIV knowledge was very high (median score of 7 of the 9), although 20% believed there was a cure for HIV, and 11.4% reported that HIV can be transmitted by using public toilets.
More than one-third of women met the USPHS summary guidance criteria for PrEP.21 These women were more likely to report higher levels of worry of acquiring HIV than women not meeting these criteria [46.3% versus 11.7%, respectively (P < 0.0001)] and a self-assessed risk of getting HIV [moderate or higher: 15.8% versus 6.2%, (P < 0.0001)] (see Appendix, Supplemental Digital Content, http://links.lww.com/QAI/B465). Only 30.3% of surveyed women had heard of PrEP before the survey; with the most common source of knowledge from an advertisement (35.7%). Only 29.4% of PrEP-aware women reported hearing about PrEP from a medical provider. Few factors were associated with PrEP awareness (Table 3), and in the multivariable analysis, only knowing someone on PrEP [adjusted odds ratio (aOR) 14.33 95% confidence interval (CI): (2.82 to 72.87)] was predictive of pre-existing PrEP knowledge.
Once PrEP was explained, PrEP attitudes were relatively positive as follows: a median PrEP stigma score of 3.2 of the 5 (5 represents the lowest stigma) and a median belief in PrEP effectiveness 3.8 of the 5 (5 represents the highest effectiveness) (Table 4). About a third (28.4%) considered starting PrEP in the next 6 months, with protecting health (76.8%) and reducing HIV worry (58.1%) the most common reasons (Table 4). More women who met the USPHS summary guidance criteria for PrEP considered starting PrEP than women who did not meet the criteria (40.9% versus 22.4% respectively, P = 0.002) (see Appendix, Supplemental Digital Content, http://links.lww.com/QAI/B465). A number of factors were associated with considering starting PrEP in bivariate analysis, with being Latina [aOR 3.30, 95% CI: (1.2 to 8.99)], recently having an STI [aOR 2.39, 95% CI: (1.25 to 4.59)], and a higher belief in PrEP effectiveness [aOR 1.85, 95% CI: (1.22 to 2.82)] remaining significant in the multivariable model (Table 5).
Women noted that if they were to decide to take PrEP, most preferred to start PrEP in their usual source of medical care (64.3%), followed by a STI clinic (12.2%) or a family planning clinic (8.4%) (Table 4). Preferred places for regular PrEP care follow-up were slightly different, although the usual source of care remained most common (56.8%), followed by a pharmacy (18.6%), STI clinic (12.2%), and family planning clinic (5.1%). The top reasons influencing where women would want to receive PrEP included cost (23.5%), familiarity with the clinic (22.2%), confidentiality (22.7%), and ease of access (13.8%).
Most women (80.7%) reported concerns about taking PrEP that included side effects (68.4%), incomplete HIV protection (25.4%), cost (24.3%), and drug interactions (23.2%). Almost three-quarters (72.2%) said they would need some form of support around using PrEP, including financial support (34.6%), disclosure to partners and/or family (25.4%), and adherence (29.5%) (Table 4).
Among the 16 FG participants, 14 (87.5%) were African American, with a mean age of 44 years (range 26–62 years). Among the 7 key informants (KIs), 6 (85.7%) were African American with a mean age of 46.7 years. At the time of the KIIs, 6 of the participants were using PrEP (duration of use ranging from 1 to 18 months), and one participant had discontinued PrEP after 2 weeks because of side effects.
Qualitative themes from FGs with PrEP-naive women generally aligned with survey results and provided contextual information not identified in the survey, including problems with current PrEP screening and advertising. KII findings identified multiple pathways to PrEP use that have relevance for improving PrEP uptake among cisgender women. Both data sources yielded recommendations for PrEP interventions for cisgender women vulnerable to HIV.
PrEP Awareness and Knowledge Among PrEP-Naive Women
Analysis of FG data indicated that less than a third had heard of PrEP before the screening for the FG eligibility. Of these, a few had seen a citywide PrEP marketing campaign (PrEP4Love),16 one woman knew someone on PrEP through her social network, and another woman had been offered PrEP at a local program for women with substance abuse and/or criminal legal system histories. Women were surprised to learn that PrEP had received the FDA approval in 2012, and expressed anger and confusion that they had not been educated about PrEP given the impact of HIV on their communities, their engagement in routine HIV-testing, and their use of multiple health, social, and research systems focused on HIV/AIDS. As one woman stated: “I just want to know, is there a place that we can go and get the information about PrEP, is (there someone) that's administering the pill or whatever? Because, like I said, every six months. They're going down there, and why are you not telling me about this?”
In expressing their anger, some women reported feeling like information about PrEP had been kept secret, pointing to a sense of medical and governmental mistrust. As noted by one woman:
“Why is it secret if it's important for the community? Is it a game to the government? …we actually have the medication to prevent it. But guess what? We're not advertising… it's not on TV on an everyday basis… But you'll hear all these [other] commercial things…It's like—okay, that's cute. But, you know, herpes don't kill you; HIV does.”
Similarly, another woman felt like low-income communities were having information intentionally hidden from them:
“I feel like there are, probably, certain communities that know about it; it just depends on what community you're in. So, the poverty communities, nine times out ten, they're not going to tell you anything. Figure it out the best way you can. Because the population is already high, as far as they say, so why not go ahead and knock some of these folks off. More funerals.”
Even among the women who had heard of PrEP, most were uncertain about how it worked or if it was relevant to them. For example, one of the women who reported seeing a PrEP4Love advertisement indicated that the campaign seemed to target men, not women. Women who were PrEP-naive reported overall high levels of openness to PrEP, with several reporting that they were going to talk with their provider about PrEP. One woman described talking to her provider at her next visit:
“I'll go pull out my phone, and say, ‘I'm glad you got some time because I'm paying right now to see me. So, give me a second, let me go on Google, and pull everything out, and now you do have the information PrEP, we're going to sit here, we're going to get this knowledge together, and I want you to put me on this pill, so I can protect myself.’”
Despite mistrust in the health care system, in general women trusted their individual health care providers and reported being open to receiving information from their primary care providers, gynecologists, case managers, psychiatrists, and HIV testers. Women underscored the importance of having a trusted health provider introduce PrEP. However, despite the overall openness toward PrEP, some FG women indicated that they would not take PrEP because it did not align with their current circumstances or risk perceptions. However, other women reported that PrEP would reduce their worry about HIV infection. In particular, they noted concerns and risks associated with their male partners' infidelity, “if you gonna lie to me and ain't going tell the truth about what you out here messing around with these different women—and you catch something, I'm trying to protect myself…”. For these women, protection against HIV with PrEP use reduces worry about infection from nonmonogamous partners.
Paralleling survey findings, the primary concerns about taking PrEP were side effects, stigma, and having the finances to cover PrEP. Women were also concerned about PrEP interacting with other medications or exacerbating preexisting conditions. Among women of childbearing age, a major concern was how PrEP would affect fetal development. One woman asked: “if you're pregnant…does it affect the baby or anything in that way? I would like to know that information...” Additional concerns identified by women included stigma and how to handle disclosure to romantic and sexual partners.
Among the women who had initiated PrEP, most had done so after a possible exposure to HIV, with exposures occurring in both ongoing and casual relationships (ie, partner infidelity, condom failure, and condomless sex) or sexual assault. Four accessed PrEP through a county health clinic (2 heard about PrEP from HIV screening and PrEP project staff, one from a friend referral, and one from a partner referral), 2 accessed PrEP through a community health center (both had established care at the center), and one accessed PrEP through a research study.
For many KIs, PrEP initiation was rapid and few discussed needing additional time to consider PrEP uptake. Specifically, 2 initiations were immediate and 3 initiations were within 1 month of requesting or being offered PrEP with minor lags due to scheduling clinic appointments. Most participants received same-day prescriptions. For these women, taking PrEP was a form of empowerment that enabled them to protect themselves independent of others' actions: “…for protecting me, everybody else needs to protect them, and I don't have to be part of it.” In contrast to the women in the FG, these women were told about PrEP from clinical providers when seeking HIV testing or birth control. Similar to the survey results, after starting PrEP, women identified side effects as a primary barrier to staying on PrEP.
In both KII and FG, women provided suggestions for how to increase PrEP uptake. In both groups, women who had seen PrEP advertisements reported that these marketing efforts were not impactful because they were not perceived as targeting women or their communities. Women's top 3 recommendations for interventions to improve PrEP uptake included targeted advertising in public health settings; sharing information about PrEP through social networks, community events, and support groups; and increasing PrEP-related communication from medical providers. Women reported it was especially important to have trusted community ambassadors share information to overcome medical/pharmaceutical distrust, as illustrated by the advice offered to the research team by one of the KII women: “Basically, you're gonna have to get a lot of more African American women to get out here and advocate for you all. Because if it's coming from you all (the interviewer), only thing they're—gonna take a look at is the dollar sign behind it. I'm gonna be honest with you…you all need to get some more African-American women that are actually from the street that's tired of the street –– and have them advocate for you all.”
The KIs offered a number of options to support disclosure of PrEP use, such as talking to a health care provider, to have accurate facts about PrEP before disclosing medication use with others, and enlisting peers to support PrEP discussions. They also discussed communication strategies that could be useful, such as appropriate timing of disclosure in relationships and the ability to assess the recipient's comfort level with the discussion. Participants also noted the importance of developing self-efficacy to “own what you're doing.” FG participants also noted the need for communication skills and PrEP information to prepare for disclosure, including needs for age appropriate information to be able to discuss with children, partners, and other family members. “I'd try to explain to my seven-year-old as best as a seven year old can comprehend that mommy's taking something to make her better. And I'd explain to him how important health is and why.”
KIs did not discuss interventions to support PrEP adherence directly, but strategies emerged from participants' accounts of their adherence. These strategies included routinizing daily pill taking, such as taking PrEP with other medications or at mealtimes, and adherence aides, such as pill boxes and cell phone reminders. FG participants did express the need to ensure medication privacy in shared living spaces (eg,.discreet storage, packaging, etc.) to prevent any unplanned disclosure and the need for packaging to aid in adherence. Desired support for adherence to PrEP-specific medical visits was also mentioned, including easier access to health providers, travel assistance when needed, and combining PrEP visits with other health care visits.
In our study in Chicago, we found low PrEP awareness and knowledge among cisgender women despite one-third of the survey sample meeting PrEP criteria and significant public health work to increase availability of and community education around PrEP.16 However, once PrEP was explained, most of the women reported positive attitudes toward PrEP, with almost one-third of survey respondents interested in starting PrEP in the near future. In addition, these women had clear preferences of where they would like to receive PrEP information and PrEP care, and what type of support they would need to overcome barriers at the individual, partner, and health system levels. Seventy percent of women had a regular source of care, largely physician offices or health centers, which were also the most common place where they wanted to receive information and start PrEP.
The low levels of PrEP knowledge were consistent with a number of other studies of cisgender women.7,9 Among the women surveyed, the only factor associated with PrEP awareness before the study was knowing someone who was taking PrEP. Information preferences, once informed about PrEP, also highlighted the potential role of leveraging social networks to expand PrEP uptake, a strategy that has been used to increase PrEP among black men who have sex with men.14 The AIDS Foundation of Chicago also had initiated a social marketing campaign explicitly targeted to women of color (SpreadTingle) https://www.aidschicago.org/page/news/all-news/viiv-healthcare-and-afc-partner-to-improve-womens-health).
One recurrent finding in the quantitative and qualitative results was the importance of having a trusted health care provider as the preferred source of PrEP information, as well as using women's usual source of health care to access PrEP. These results were consistent across both quantitative and qualitative data, despite the fact that survey respondents were accessing care at different care sites (STI clinic or ED) rather than their regular source of care. Use of EDs and STI clinics by patients who have access to primary care has been previously described and also highlights the opportunity for providers in urgent or other episodic care sites to discuss an HIV risk and PrEP and be knowledgeable about referral options for women who express interest.27 The preference for PrEP access at regular sources of care emphasizes the importance of health system responsiveness (familiarity, feeling welcomed, confidentiality, and access-financial and otherwise), a factor previously found important for adherence in people living with HIV in other settings.28 In general, distrust of the medical system has previously been identified as a significant barrier to PrEP uptake and HIV care adherence among black women.11,29 Although system change, including addressing structural barriers and intrinsic and extrinsic bias, is needed to overcome this barrier, results from our study suggest that leveraging already trusted members of the medical community is an important facilitator. However, this work will also need to include building the capacity of trusted primary care providers to integrate PrEP into routine care.30 Models of integration of HIV and primary care and other chronic care models offer strategies that can be adapted to provide the identified support needs for these women to start and remain on PrEP.31
Potential barriers and needed support identified in both quantitative and qualitative findings included concerns about side effects, drug interactions, disclosure, financial challenges, and incomplete HIV protection as well as remembering to take a daily pill. These findings are consistent with previous PrEP research as well as earlier findings for HIV-positive women and antiretroviral therapy.4,9
The relatively lower PrEP stigma is in contrast with some other studies, although our population differed in care sites and demographics. Calabrese et al4 studied PrEP stigma among women attending Planned Parenthood clinics, finding both negative PrEP-user stereotypes and expected external disapproval if started, both associated with less interest in starting PrEP. The high interest in PrEP once made aware of the medication was consistent with a number of studies as well as the anger about not being informed about PrEP despite routinely accessing medical care and HIV prevention services.8,9
Our study had a number of limitations. The survey sample was composed of women accessing medical care for sexual health or urgent care needs, and may not represent the knowledge and attitudes of women attending routine primary care visits, those seeking care in reproductive health clinics or women not seeking care at all. All data were obtained through a self-report and may thus be subject to social desirability bias. In addition, a number of the questions and scales we used have only been validated in other populations, such as men who have sex with men, and work is needed to ensure that the psychometrics are valid among cisgender women, particularly black women. Because of limited resources, we could not also interview providers, but that is part of an ongoing follow-on study being led by some of the authors. Finally, our findings are based on cross-sectional data and cannot be used to make causal inferences on women's PrEP knowledge, attitudes, and experiences.
Despite these limitations, our study is one of the first to use mixed-methods and include both PrEP-experienced and PrEP-naive women, adding to the growing literature on how to improve the PrEP care continuum among black and other cisgender women. The women offered concrete suggestions on how to improve PrEP-related messaging and the resources needed to help women understand, initiate, and remain on PrEP. Research is needed on how to build on these suggestions to develop and scale-up culturally and gender-relevant interventions to improve cisgender women's awareness and knowledge and uptake of PrEP. Settings for such interventions should leverage the trust of already established health care providers, or community-based organizations and social networks. These results have been shared with the broader community, including women and service providers, and work has started to better understand how to design effective strategies to increase PrEP access across the continuum to contribute to the local Getting to Zero efforts and the national work to End the HIV Epidemic.
Input into the survey was generously provided by a number of people, including Brian Mustanski, Jaimie Meyers, and Sara Calabrese. The authors thank the staff at the STI clinic, ED, and the community-based organization that helped recruit women. Finally, none of this work would have happened without the generous sharing of the lived-experience and insights among the women who participated in this study.
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