Abstract
Background:
The PrEP cascade outlines sequential steps to maximize PrEP’s impact and highlights potential intervention targets to improve PrEP implementation. We evaluate the PrEP cascade in the Together 5,000 study (T5K).
Methods:
T5K is an internet-based, U.S. national cohort study of PrEP-eligible men and trans persons who have sex with men who were not taking PrEP at enrollment. Using longitudinal data from baseline (2017–2018) and year one follow-up (2018–2019, n=4,229), we evaluated five steps of the PrEP cascade—PrEP contemplation: believes they are a good candidate for PrEP; PrEParation: plans to initiate PrEP; PrEP action: speaks to a provider about PrEP; PrEP initiation: receives a prescription for PrEP; and PrEP maintenance: continues to take PrEP. We compared the cascade across geographic region and identified factors associated with gaps in the cascade.
Results:
After one year, 1092 (26%) participants had initiated PrEP, 709 (17%) were still using PrEP, and 177 (4%) were no longer clinically indicated for PrEP. Participants in the South and Midwest were less likely to speak to a provider about PrEP or initiate PrEP. Baseline characteristics associated with lower odds of PrEP initiation at year one include: not having a college degree; earning <$20,000/year; not having health insurance; having very low food security; and not having a primary care doctor.
Conclusions:
Lack of healthcare access is a major barrier to PrEP implementation and may exacerbate disparities in PrEP uptake across geographic regions.
Keywords: HIV prevention, Pre-exposure prophylaxis, PrEP Cascade, sexual minorities
INTRODUCTION
In 2019, the US federal government announced its plan for ending the HIV epidemic in America by 2030—with goals of a 75% reduction in HIV infections over 5 years and a 90% reduction in 10 years.1 Daily oral HIV pre-exposure prophylaxis (PrEP) is an effective tool for preventing HIV and its widespread uptake and use is critical to meet these targets. However, of the estimated 1 million Americans at risk of HIV, fewer than 1 in 4 are currently using PrEP, and PrEP uptake and use is lowest among those populations most affected by HIV.2–5
The PrEP Continuum of Care (or PrEP cascade) outlines key sequential steps that must be achieved for PrEP to be effective in preventing HIV at a population level.6 These steps include 1) objectively eligible for PrEP use (HIV-negative and at risk of HIV infection); 2) PrEP contemplation: willingness to take PrEP and self-identifies as a good candidate for PrEP use; 3) PrEParation: intention to begin taking PrEP and identification of a PrEP provider; 4) PrEP action: communication with a provider about PrEP; 5) PrEP initiation: receipt of a prescription for PrEP; and 6) PrEP maintenance: persistent adherence and receiving quarterly HIV and sexually transmitted infection (STI) testing. Each step along the cascade serves as a benchmark to evaluate and identify barriers to successful PrEP implementation.
Prior studies have described the PrEP cascade among insured populations or at PrEP clinics in narrow geographic locations, but these studies are restricted to those with health insurance, an existing PrEP prescription, or access to PrEP providers.7–11 Geosocial apps are popular among sexual minorities—especially among younger individuals-- and previous research found that men who have sex with men (MSM) who identify partners over the internet are more likely to have condomless sex.12–14 Few studies have evaluated the PrEP cascade in among geosocial app users, so barriers to PrEP interest and uptake in these populations are not well-understood. Identifying and addressing these barriers will be essential for meeting the national HIV incidence reduction goals. Finally, few studies have explored earlier steps of the cascade—interest in and knowledge of PrEP and linkage to PrEP services—or evaluated the cascade longitudinally to assess how far along the cascade PrEP candidates get after having expressed intentions to begin PrEP in the future.
The Together 5000 study (T5K) recruited a geographically diverse internet-based cohort of HIV-negative participants who were not taking PrEP but who otherwise met key PrEP candidacy criteria.15,16 Here, we describe the PrEP cascade in the T5K cohort. We assess PrEP eligibility, PrEP contemplation, and PrEParation at baseline; and we assess PrEP action, PrEP initiation, and PrEP maintenance after 12 months of follow-up. We explore regional differences in the PrEP cascade, and we identify individual and structural factors associated with PrEP action and initiation by year one.
METHODS
Study population and procedures
T5K is an ongoing, internet-based cohort of PrEP-eligible men and trans persons who have sex with men designed to identify missed opportunities for HIV prevention and PrEP uptake among persons at-risk for HIV. Participants were recruited through advertisements on several men for men geosocial phone applications between October 2017 and June 2018. Study participants were required to be men, trans men, or trans women; between 16 and 49 years old; have had at least 2 male sex partners in the 3 months prior to enrollment; not currently participating in an HIV prevention clinical trial; not on PrEP at enrollment; self-reported HIV-negative or unknown HIV status; and met one other PrEP indication criteria.15 The study aimed to recruit 50% persons of color, which it achieved without needing to employ stratification. Details on sampling methodology have been published elswhere.15,17
There were 8,754 participants who met the screening criteria and consented to participate in T5K; of these, 6,266 completed a secondary incentivized enrollment survey; 5,000 returned a valid at-home HIV test kit at baseline (of which n = 4,809 were confirmed HIV-negative); and 4,379 completed the 12-month questionnaire.15,16 Participants who were diagnosed with HIV at enrollment (n = 191) would not be eligible for consideration of PrEP uptake and thus were excluded from analyses. Likewise, participants diagnosed before or at their month 12 assessment (n = 78) were also excluded from analyses. We have separately published on factors associated with HIV diagnosis at enrollment,18 as well as seroconversions by month 12.19 Because confirmed HIV-negative status is an essential component of PrEP eligibility, we restricted our sample to include only those participants who were confirmed to be HIV-negative at baseline via the study-provided at-home HIV test and were confirmed HIV-negative at follow up (n = 4,229). We consider all the included participants to be objectively eligible (i.e., clinically indicated) for PrEP at baseline based on the study inclusion criteria and confirmed HIV-negative status.
Cascade Measurements
We define the subsequent cascade steps based on participants’ responses to the baseline and month 12 questionnaires as shown in Table 1. Additionally, participants were asked about specific barriers/concerns and reasons for not advancing to the next step of the cascade. These questions are included in Appendix A.
Table 1:
The PrEP Cascade
| Cascade Step | Defintion |
|---|---|
| PrEP contemplation | At baseline, participant believes they are an appropriate candidate for PrEP |
| PrEParation | At baseline, participant plans to inititiate PrEP within the next year |
| PrEP action | By month 12, participant has spoken to a provider about PrEP in the prior year |
| PrEP initiation | By month 12, participant has received a prescription for PrEP in the prior year |
| PrEP maintenance | By month 12, participant is currently taking PrEP |
Predictors of PrEP Action and PrEP Initiation at Month 12
We explored characteristics and structural factors associated with PrEP action and PrEP initiation by month 12. Variables of interest included demographics, sexual behavior, drug use, and structural characteristics previously shown to be related to HIV infection or PrEP uptake. Demographics variables of interest were geographic region, race, age, gender identity, sexual orientation, and highest level of education. Baseline measures of sexual behavior and health status were number of male anal sex partners (prior 3 months), number of HIV-positive male partners (prior 3 months), STI infection in the prior year, having anxiety or depression as measured by the 4 item patient health questionnaire (PHQ-4), and history of sex work (prior 3 months). Baseline structural characteristics of interest were income in the prior year, employment status, health insurance status, having a primary care doctor, recent housing instability, and food insecurity. Baseline drug use measures included history of sharing needles to inject drugs and recent methamphetamine use. We additionally included measures of familiarity and exposure to PrEP such as knowing a PrEP provider, knowing other people taking PrEP, and a barriers to PrEP uptake score.
Statistical Analysis
This is a descriptive study that primarily focuses on assessing the PrEP cascade over one year of follow-up in T5K. We report the overall proportion of participants in each step of the PrEP cascade by month 12. We stratified the cascade by region, race, and gender to explore potential differences among these factors, and used chi-squared tests and Wilcoxson rank-sum tests, as appropriate, to compare the cascades across subgroups.
To evaluate factors associated with PrEP action and PrEP initiation by month 12, we used unadjusted logistic regression among all participants and restricted to those who had reached the prior step of the cascade. To explore regional differences, we conducted secondary analyses that included interaction terms between geographic region and each predictor.
RESULTS
Baseline Demographics
Table 2 shows the baseline characteristics of the study population. At baseline, 638 (15%) had prior PrEP experience but were not currently taking PrEP. Participants were on average 31 years old, were white (55%), lived in the South (46%), and identified as cis men (98%). In total, 35% of participants were working less than full-time, 30% made less than $20,000 per year, 23% did not have health insurance, and 17% had experienced housing instability in the previous 5 years.
Table 2.
Baseline Demographics (n = 4229)
| n (%) | ||
|---|---|---|
| Prior PrEP Use | Don’t know what PrEP is | 180 (4.3%) |
| Never taken PrEP | 3,411 (80.7%) | |
| Previously taken PrEP, but not taking PrEP currently | 638 (15.1%) | |
| US Region | Northeast | 634 (15.0%) |
| Midwest | 650 (15.4%) | |
| South | 2,008 (47.5%) | |
| West | 913 (21.6%) | |
| US Possession/Overseas Military | 22 (0.5%) | |
| Race or Ethnicity | White | 2,312 (54.7%) |
| Black | 384 (9.1%) | |
| Latinx | 997 (23.6%) | |
| All other/ Multi | 536 (12.7%) | |
| Gender | Cisgender Male | 4,134 (97.8%) |
| Transfemale | 18 (0.4%) | |
| Transmale | 32 (0.8%) | |
| Something Else (assigned male sex at birth) | 45 (1.1%) | |
| Education | Less than high school diploma | 76 (1.8%) |
| High school diploma or GED | 510 (12.1%) | |
| Some college or associate’s degree | 1,833 (43.3%) | |
| College graduate or higher | 1,810 (42.8%) | |
| Employment Status | Full time | 2,766 (65.4%) |
| Part time | 500 (11.8%) | |
| Working or full-time student | 611 (14.4%) | |
| Unemployed/other | 352 (8.3%) | |
| Annual Income | <$20,000 | 1,282 (30.3%) |
| $20,000-$49,999 | 1,784 (42.2%) | |
| $50,000 or greater | 1,163 (27.5%) | |
| Health Insurance | No | 944 (22.8%) |
| Yes | 3,194 (77.2%) | |
| Experienced housing instability in past 5 years | No | 3,494 (82.6%) |
| Yes | 735 (17.4%) | |
| Transactional Sex | No | 3,698 (87.4%) |
| Yes | 531 (12.6%) | |
| Sexual Orientation | Gay, Queer, Homosexual | 3,630 (85.8%) |
| Bisexual | 551 (13.0%) | |
| Other (reports sex with men) | 48 (1.1%) | |
| STD in past year | No | 3,505 (82.9%) |
| Yes | 724 (17.1%) | |
| Shared needles to inject drugs (e.g. heroin, steroids, crystal)? | No, never | 4,108 (97.1%) |
| Yes, in the last 12 months | 61 (1.4%) | |
| Yes, more than one year ago | 60 (1.4%) | |
| Meth use in the past 3 months | No | 3,886 (91.9%) |
| Yes | 343 (8.1%) | |
| Has a primary care doctor | No | 1,955 (46.2%) |
| Yes | 2,274 (53.8%) | |
| mean (SD) | ||
| Age | 30.9 (7.9) | |
| # Male Anal Sex Partners, < 3 months | 5.5 (6.7) | |
| # HIV+ Male Partners, < 3 months | 0.5 (2.9) | |
One Year PrEP Cascade
At baseline, and per enrollment criteria, all participants were clinically indicated for PrEP care; however, only 3555/4229 (84%) believed they were appropriate candidates for PrEP and 2826/4229 (67%) planned to begin taking PrEP within the next year. By month 12, 1834/4229 (43.4%) had spoken to a medical provider about PrEP; 1092/4229 (26%) had received a prescription for PrEP; and 709/4229 (17%) were taking PrEP at the time of their month 12 assessment (Figure 1). In total, 177/4229 (4%) were no longer clinically eligible for PrEP because they reported no condomless anal intercourse in the prior 3 months, no STDs in the past year, no HIV-positive male partners in the past year, and no methamphetamine use in the past year.
Figure 1.
The 1-year PrEP Cascade in the Together 5000 Study
Figure 2 shows the PrEP cascade stratified by geographic region. Patterns in the cascade are similar across all regions for PrEP contemplation (p=0.53) and PrEParation (p=0.53); but among participants who had planned to take PrEP in the following year, participants living in the Midwest and South were less likely to have spoken to a provider about PrEP at month 12 (OR: 0.7, 95% CI [0.6, 1.0] and OR: 0.7, 95% CI [0.5, 0.9] respectively).
Figure 2.
The 1-year PrEP Cascade in the Together 5000 Study by region
The most common reasons cited for not planning on taking PrEP within a year from baseline were cost (58%) and concerns about side effects (53%). Compared to the other regions, the pattern differed in the Northeast where the most common reasons for not planning on taking PrEP in the next year were concerns about side effects (42%) and feeling that they were not at high enough risk for PrEP (33%).
Among those who planned on taking PrEP within a year from baseline, the most common reasons given for not having yet spoken to a healthcare provider about PrEP by month 12 were cost (41%) and not having seen a provider in the past year (35%). These patterns were consistent across geographic regions.
Predictors of PrEP Action
Of the 2,826 participants who planned on taking PrEP within a year from baseline, 1834 (65%) had spoken to a provider about PrEP by month 12. Table 3 shows the characteristics of participants who reached PrEP Action and PrEP Initiation by month 12.
Table 3.
Characteristics of participants who reach PrEP Action and PrEP Initiation by 12 months.
| PrEP Action (n = 2826)a | PrEP Initiation (n = 1834)b | ||||||
|---|---|---|---|---|---|---|---|
| Variable | Response | No (n = 992) | Yes (n = 1834) | p-value | No (n = 742) | Yes (n = 1092) | p-value |
| Education | Less than high school diploma | 24 (2.4%) | 25 (1.4%) | <0.001 | 12 (1.6%) | 13 (1.2%) | 0.003 |
| High school diploma or GED | 155 (15.6%) | 159 (8.7%) | 78 (10.5%) | 81 (7.4%) | |||
| Some college or associate’s degree | 472 (47.6%) | 754 (41.1%) | 326 (43.9%) | 428 (39.2%) | |||
| College graduate or higher | 341 (34.4%) | 896 (48.9%) | 326 (43.9%) | 570 (52.2%) | |||
| Employment | Full-time | 650 (65.5%) | 1,220 (66.5%) | 0.18 | 481 (64.8%) | 739 (67.7%) | 0.28 |
| Part-time | 126 (12.7%) | 196 (10.7%) | 75 (10.1%) | 121 (11.1%) | |||
| Working or full-time student | 126 (12.7%) | 269 (14.7%) | 121 (16.3%) | 148 (13.6%) | |||
| Unemployed/other | 90 (9.1%) | 149 (8.1%) | 65 (8.8%) | 84 (7.7%) | |||
| Income Last Year | <$20,000 | 335 (33.8%) | 499 (27.2%) | <0.001 | 234 (31.5%) | 265 (24.3%) | 0.002 |
| $20,000-$49,999 | 452 (45.6%) | 771 (42.0%) | 298 (40.2%) | 473 (43.3%) | |||
| $50,000 or greater | 205 (20.7%) | 564 (30.8%) | 210 (28.3%) | 354 (32.4%) | |||
| Housing Instability in past 5 years | No | 787 (79.3%) | 1,537 (83.8%) | 0.003 | 624 (84.1%) | 913 (83.6%) | 0.78 |
| Yes | 205 (20.7%) | 297 (16.2%) | 118 (15.9%) | 179 (16.4%) | |||
| Transactional Sex, < 3 months | No | 841 (84.8%) | 1,627 (88.7%) | 0.003 | 654 (88.1%) | 973 (89.1%) | 0.52 |
| Yes | 151 (15.2%) | 207 (11.3%) | 88 (11.9%) | 119 (10.9%) | |||
| Meth use in the past 3 months | No | 886 (89.3%) | 1,696 (92.5%) | 0.004 | 683 (92.0%) | 1,013 (92.8%) | 0.57 |
| Yes | 106 (10.7%) | 138 (7.5%) | 59 (8.0%) | 79 (7.2%) | |||
| STI in past year | No | 858 (86.5%) | 1,420 (77.4%) | <0.001 | 603 (81.3%) | 817 (74.8%) | 0.001 |
| Yes | 134 (13.5%) | 414 (22.6%) | 139 (18.7%) | 275 (25.2%) | |||
| Gender | Male | 975 (98.3%) | 1,788 (97.5%) | 0.046 | 727 (98.0%) | 1,061 (97.2%) | 0.36 |
| Trans female | 8 (0.8%) | 7 (0.4%) | 3 (0.4%) | 4 (0.4%) | |||
| Trans male | 3 (0.3%) | 16 (0.9%) | 3 (0.4%) | 13 (1.2%) | |||
| Other | 6 (0.6%) | 23 (1.3%) | 9 (1.2%) | 14 (1.3%) | |||
| Region | Northeast | 124 (12.5%) | 302 (16.5%) | 0.01 | 104 (14.0%) | 198 (18.1%) | 0.11 |
| Midwest | 160 (16.1%) | 283 (15.4%) | 121 (16.3%) | 162 (14.8%) | |||
| South | 501 (50.5%) | 814 (44.4%) | 341 (46.0%) | 473 (43.3%) | |||
| West | 202 (20.4%) | 426 (23.2%) | 170 (22.9%) | 256 (23.4%) | |||
| US Possession/ Overseas Military | 4 (0.4%) | 8 (0.4%) | 5 (0.7%) | 3 (0.3%) | |||
| Missing | 1 (0.1%) | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) | |||
| Race | White | 516 (52.0%) | 997 (54.4%) | 0.52 | 419 (56.5%) | 578 (52.9%) | 0.20 |
| Black | 100 (10.1%) | 160 (8.7%) | 58 (7.8%) | 102 (9.3%) | |||
| Latino | 250 (25.2%) | 443 (24.2%) | 182 (24.5%) | 261 (23.9%) | |||
| Other/Multi | 126 (12.7%) | 234 (12.8%) | 83 (11.2%) | 151 (13.8%) | |||
| Health Insurance | No | 234 (23.6%) | 341 (18.6%) | 0.001 | 147 (19.8%) | 194 (17.8%) | 0.24 |
| Yes | 736 (74.2%) | 1,458 (79.5%) | 578 (77.9%) | 880 (80.6%) | |||
| Missing | 22 (2.2%) | 35 (1.9%) | 17 (2.3%) | 18 (1.6%) | |||
| Food Security | Food Secure | 599 (60.4%) | 1,208 (65.9%) | 0.01 | 468 (63.1%) | 740 (67.8%) | 0.08 |
| Low Food Security | 144 (14.5%) | 261 (14.2%) | 115 (15.5%) | 146 (13.4%) | |||
| Very Low Food Security | 228 (23.0%) | 341 (18.6%) | 151 (20.4%) | 190 (17.4%) | |||
| Missing | 21 (2.1%) | 24 (1.3%) | 8 (1.1%) | 16 (1.5%) | |||
| Anxiety | Normal | 434 (43.8%) | 777 (42.4%) | 0.093 | 297 (40.0%) | 480 (44.0%) | 0.12 |
| Mild | 273 (27.5%) | 560 (30.5%) | 235 (31.7%) | 325 (29.8%) | |||
| Moderate | 145 (14.6%) | 287 (15.6%) | 112 (15.1%) | 175 (16.0%) | |||
| Severe | 140 (14.1%) | 210 (11.5%) | 98 (13.2%) | 112 (10.3%) | |||
| Has a primary care doctor | No | 536 (54.0%) | 732 (39.9%) | <0.001 | 310 (41.8%) | 422 (38.6%) | 0.18 |
| Yes | 456 (46.0%) | 1,102 (60.1%) | 432 (58.2%) | 670 (61.4%) | |||
| Know a PrEP provider | No | 518 (52.2%) | 627 (34.2%) | <0.001 | 281 (37.9%) | 346 (31.7%) | 0.01 |
| Yes | 474 (47.8%) | 1,207 (65.8%) | 461 (62.1%) | 746 (68.3%) | |||
| Where would you feel most comfortable getting a PrEP prescription? | Regular primary care provider | 362 (36.5%) | 770 (42.0%) | 0.01 | 305 (41.1%) | 465 (42.6%) | 0.35 |
| A clinic specializing in HIV-related care | 184 (18.5%) | 273 (14.9%) | 123 (16.6%) | 150 (13.7%) | |||
| A clinic specializing in sexual health | 141 (14.2%) | 218 (11.9%) | 92 (12.4%) | 126 (11.5%) | |||
| A clinic specializing in LGBT health care | 277 (27.9%) | 519 (28.3%) | 198 (26.7%) | 321 (29.4%) | |||
| Other | 28 (2.8%) | 54 (2.9%) | 24 (3.2%) | 30 (2.7%) | |||
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||||
| Age | 30.2 (7.8) | 30.9 (7.7) | 0.02 | 31.0 (8.0) | 30.8 (7.5) | 0.58 | |
| # Male Anal Sex Partners, < 3 months | 5.3 (5.8) | 6.4 (8.1) | <0.001 | 5.8 (6.1) | 6.7 (9.3) | 0.02 | |
| # HIV+ Male Partners, < 3 months | 0.6 (2.8) | 0.7 (3.7) | 0.96 | 0.5 (1.5) | 0.8 (4.6) | 0.09 | |
| # People known on PrEP | 2.4 (2.0) | 3.0 (2.0) | <0.001 | 2.8 (2.0) | 3.1 (2.0) | 0.01 | |
| Barriers to PrEP Uptake Score | 27.2 (8.1) | 26.3 (7.3) | 0.002 | 26.9 (7.3) | 25.8 (7.3) | 0.001 | |
Characteristics of those who spoke to a provider about PrEP by month 12 among those who had stated that they planned to begin PrEP in the following year
Characteristics of those who received a prescription for PrEP by month 12 among those who had spoken to a provider about PrEP
p-values are from chi-squared tests (for categorical variables) or t-tests (for continuous variables)
Among those participants who indicated that they planned on taking PrEP within a year from baseline (PrEParation), factors associated with having spoken to a provider about PrEP by month 12 (PrEP Action) were having a college education (OR: 2.5, 95% CI [1.4, 4.5]), earning $50,000 or more annually (OR: 1.8, 95% CI [1.5, 2.3]), having an STD in the past year (OR: 1.9, 95%CI [1.5, 2.3]), having health insurance (OR: 1.4, 95% CI [1.1, 1.6]), having a primary care doctor (OR: 1.8, 95% CI [1.5, 2.1]), and knowing of a PrEP provider (OR: 2.1, 95% CI [1.8, 2.5]). Conversely, factors associated with not talking to a provider about PrEP were experiencing housing instability in the past 5 years (OR: 0.7, 95% CI[0.6, 0.9]), living in the Midwest or South (OR: 0.7, 95% CI [0.5, 1.0] and OR: 0.7, 95% CI [0.5, 0.8] respectively), methamphetamine use in the 3 months prior to baseline (OR: 0.7, 95% CI [0.5, 0.9]), and having very low food security (OR: 0.7, 95% CI [0.6, 0.9]). There was no evidence of interactions by geographic region.
Predictors of PrEP Initiation
Of the 1834 participants who spoke to a doctor about PrEP between baseline and month 12, 1092 (60%) received a prescription for PrEP. Of the 742 participants who did not receive a prescription after having spoken to a doctor about PrEP, 148 (20%) indicated that both the provider and participant had thought starting PrEP would be a good idea; 188 (25%) reported that both the provider and participant thought starting PrEP might be a good idea but they should wait a while before starting; 93 (13%) indicated that both the provider and participant decided PrEP was not a good idea; 140 (19%) indicated that their provider was not comfortable prescribing PrEP; and 173 (23%) indicated that the provider thought starting PrEP would be a good idea but the participant decided against it. Participants in the South and Midwest were more likely to report that their providers were not comfortable prescribing PrEP (21% and 22% respectively, p<0.01), while participants in the Northeast and West were more likely to state that they and their providers had mutually decided to wait to begin PrEP (35% and 32% respectively; p<0.01)
Factors associated with increased odds of receiving a prescription after having spoken to a provider about PrEP include earning $20,000-$50,000 per year or greater than $50,000 per year (OR: 1.4, 95% CI [1.1, 1.8] and OR: 1.5, 95% CI [1.2, 1.9] respectively), having an STD in the past year (OR: 1.5, 95% CI [1.2, 1.8]), and knowing of a PrEP provider (OR: 1.3, 95% CI [1.1, 1.6]). Participants who lived in the Midwest or South were less likely to receive a prescription for PrEP after having spoken to a provider (OR: 0.7, 95% CI [0.5, 1.0] and OR: 0.7, 95% CI [0.6, 1.0] respectively). Additionally, participants with severe anxiety as measured by the PHQ-4 were less likely to receive a prescription for PrEP by month 12 (OR: 0.7, 95% CI [0.5, 1.0]) (Table 3).
DISCUSSION
Overall, PrEP uptake and maintenance at after one year of follow-up was low with only 1092/4229 (26%) initiating PrEP and 709/4229 (17%) remaining on PrEP by month 12 (only 64.9% of those initiating PrEP managed to stay on PrEP over the course of the year—or one-in-three people who started PrEP ultimately stopped). The largest drop in the cascade was between PrEP action and PrEP initiation, where only 60% of the participants who spoke to a provider about PrEP actually initiated PrEP. Conversely, PrEP contemplation and PrEParation was relatively high, with 84% of participants believing they were good candidates for PrEP. Of those who believed they were eligible for PrEP, 80% planned to initiate PrEP within the following year.
Prior studies have reported lower PrEP initiation in the South,20 and we see similar patterns in the T5K cohort. This is particularly troubling, since more than half of new HIV diagnoses are in the South.3 Further, participants in the Midwest and the South were less likely to speak to a provider and initiate PrEP compared to those in the Northeast or West. Interestingly, this regional disparity seems to begin between PrEParation and PrEP action—not earlier in the cascade. This suggests that participants are similarly aware and motivated to use PrEP across regions, but face bigger barriers to accessing PrEP providers in the South and Midwest. This pattern underscores the importance of PrEP deserts, which are more common in the South and rural areas, and supports the need for alternative PrEP provision strategies to address these barriers.21,22
High cost, lack of health insurance, and inadequate access to care were consistently identified as key barriers to progress along the PrEP cascade. Self-reported concerns about cost and affordability were identified as primary reasons for why participants did not plan on initiating PrEP or why they hadn’t yet spoken to a provider about PrEP. This pattern was also evident when examining the factors that were associated with PrEP action and PrEP initiation: higher income, having health insurance, and knowing PrEP providers were all strongly associated with speaking to a healthcare provider about PrEP. Similarly, recent unstable housing and severe food insecurity –markers of low socio-economic status—were associated with being less likely to speak to a provider about PrEP. We noted that a number of programs exist to help uninsured and underinsured individuals gain access to PrEP; however, we lack data on the extent to which participants may be aware of or have utilized such programs—an important arena for future assessment.
Parallel to the structural barriers regarding access, we also noted a high number of participants expressing concerns related to anticipated side effects. Although we lack granular data as to the etiology of these concerns, we highlight a separate publication based on data collected later in cohort finding that a majority of participants had seen ads on social media seeking plaintiffs in lawsuits for harms/side-effects caused by PrEP (in spite of side effects being both rare and reversable).23 In that study, 28% said they would probably or definitely not start PrEP and 22% said they would not stay on PrEP (were they on it) as a result of seeing these ads.
Our study has several strengths. First, T5K included a geographically diverse sample of PrEP-eligible men and trans people and was not limited to only people accessing healthcare services. This provided a unique opportunity to assess the PrEP cascade among people without consistent access to care. Here, it is clear that access to care (through health insurance, availability of PrEP providers, and income) plays a major role in determining whether a person who is considering using PrEP will continue along the PrEP cascade. Samples that are limited to clinic settings may not capture the importance of these barriers, as those studies would exclude anyone who is unable to access the clinic. Another important strength of our study is that we were able to follow individuals longitudinally and assess the cascade over time. We were able to measure intentions for the coming year and subsequently assess whether individuals were able to follow-through on those intentions. This provides a better representation of how people move through the steps of the cascade than would be feasible with a cross-sectional assessment.
The present study also has several limitations. First, though we did not find any meaningful differences in the PrEP cascade by gender identity, the study sample included very few trans people. Prior work24 suggests that gender minorities may face unique barriers and challenges in accessing PrEP, and future studies should examine the PrEP cascade in these populations separately from cis men. Next, in the time between the baseline and 12-month surveys, it is possible that some participants who had initially indicated they planned on taking PrEP might have changed their mind over the course of the study. In reality, individuals are likely to move forward and backwards through the cascade over time as their circumstances change. Future work with longer follow-up time may better be able to describe these more complex trajectories and assess their impact on PrEP’s population effectiveness. We lack granularity on measures of PrEP adherence as well as the extent to which participants may have started, stopped, and restarted (and stopped) PrEP during the year of follow up.
In conclusion, the 1-year PrEP cascade in T5K highlights the need for interventions to improve the later stages of the cascade: PrEP action, PrEP initiation, and PrEP maintenance. Although many in our cohort believed that they were ideal candidates for PrEP and intended to start PrEP within the next year, cost and access to care were major barriers to initiating PrEP. These same barriers likely contribute to regional disparities in PrEP uptake. To successfully achieve broad public health impact, PrEP implementation efforts will need to address structural factors that impede individuals from successfully progressing along the PrEP cascade.
Supplementary Material
Funding:
Together 5,000 was funded by the National Institutes for Health (UG3 AI 133675 - PI Grov). Viraj V. Patel was supported by a career development award (K23MH102118). Other forms of support include the CUNY Institute for Implementation Science in Population Health, and the Einstein, Rockefeller, CUNY Center for AIDS Research (ERC CFAR, P30 AI124414).
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