Abstract
Background:
There has been an influx of ads on social media seeking plaintiffs in lawsuits for harms/side-effects caused by tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC, Truvada) for PrEP. Community groups and researchers have suggested these ads may be undermining efforts to disseminate PrEP to key populations.
Methods:
In October 2019, we began assessing the impact of injury lawsuit ads on social media platforms in an ongoing U.S. national cohort study of HIV-negative cis men, trans men, and trans women who have sex with men. Although assessments are ongoing, given the alarming nature of our findings, we report data collected as of March 2020 (n = 2,078).
Findings:
Most (59.9%) said they had seen ads for TDF-related lawsuits on social media. Twenty-eight percent said they would probably or definitely not start PrEP and 22.1% said they would not stay on PrEP (were they on it) as a result of seeing these ads. Next, 38.2% agreed or strongly agreed that seeing these ads made them think that TDF/FTC for PrEP was not safe. Black, Latinx, and/or multiracial individuals were most likely to be negatively impacted by the ads including perceptions that these ads made them think PrEP is not safe. In contrast, past year experience taking PrEP was positively associated with intentions to start and/or stay on PrEP despite seeing the ads.
Interpretation:
Due to forthcoming affordable/generic options, TDF/FTC is projected to become the most scalable option for disseminating PrEP to key populations. Results suggest that ads for TDF lawsuits on social media are having a negative impact on individual PrEP decision-making. Our findings highlight the urgency for accurate and balanced messaging on the benefits and risks of PrEP, so that individuals can make informed choices about whether PrEP is right for them
Keywords: Tenofovir alafenamide, Tenofovir disoproxil fumarate, lawsuits, social media, PrEP, gay and bisexual men
INTRODUCTION
In 2012, the FDA approved Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC, Truvada) for use as HIV Pre-Exposure Prophylaxis (PrEP). TDF/FTC formulated PrEP has proven highly effective in preventing HIV transmission and is highly tolerable in terms of its safety profile and minimal side-effects.1 As the patent for TDF/FTC formulated PrEP approaches its 2020 expiration date, more affordable generic versions of the drug are set to hit the market. Reductions in the price of TDF/FTC PrEP may help to expand uptake among key populations, which, to date, is still vastly out of pace with need.2–4
Although generally considered very safe, a small proportion patients taking TDF can experience laboratory and radiologic adverse reactions related to bone mineral density and kidney function.1,5 Studies and clinical experience have shown that if adverse reactions are detected, normal kidney function and bone mineral density recover when TDF/FTC is discontinued.6 For patients experiencing negative side effects, alternative drugs used as PrEP might be appropriate.5 In October 2019, the FDA approved Tenofovir Alafenamide/Emtricitabine (TAF/FTC, Descovy) for use as PrEP in populations assigned male sex at birth. TAF demonstrated non-inferior efficacy to TDF and statistically significant but clinically minor differences over TDF for certain key measurements of bone and renal safety. 5 However, TAF does have documented rare side effects related to weight and cholesterol changes. And, leading experts contend that TDF should be the first drug medical providers prescribe for treatment as PrEP because of its established safety profile, as well as the inevitable emergence of more affordable generics.7
Meanwhile, and starting around mid-2019, there has been an influx of ads on social media like Facebook and Instagram seeking plaintiffs in lawsuits for harms caused by TDF/FTC for PrEP.8 A 2020 commentary in Lancet HIV noted that “these advertisements promote false information about the safety of PrEP [TDF] by suggesting that rare side-effects (e.g., renal failure and substantial bone loss) are commonplace.”9 These ads have received millions of views and medical providers are now finding themselves fielding questions from patients about the efficacy and side-effects associated with PrEP. To our knowledge, there are no published studies evaluating the impact these ads may have on key populations for which PrEP is indicated. To that end, we examined the impact of these ads in an ongoing U.S. national cohort of HIV-negative cis men, trans men, and trans women who have sex with men.
METHODS
Data are taken from Together 5,000, an ongoing U.S. national internet-based cohort study predominantly composed of cisgender gay and bisexual men, but also includes some transgender women and transgender men who have sex with men.10–12 Enrollment for the cohort occurred between October 2017 and June 2018 and participants themselves were invited via ads on men-for-men geosocial networking apps. The cohort includes over 8,000 individuals from all 50 states, Puerto Rico, and Guam. Participants complete annual online assessments as well as at-home self-administered HIV testing (oral fluid sample mailed to a lab for analysis). In October 2019, we began inviting participants to complete their month 24 follow up assessment that included measures on the impact of these social media ads. Although assessments are ongoing through summer 2020, given the alarming nature of our findings, we report data collected as of March 2020, which includes responses from n = 2,204 participants. Note, we excluded responses from HIV-positive participants (n = 126), as questions about whether they would use PrEP would not be appropriate. Thus, final sample size for the present analyses is n = 2,078.
To be eligible for enrollment, participants had to be aged 16 to 49; had at least two male sex partners in the past three months; were not currently participating in an HIV vaccine or PrEP clinical trial; were not on PrEP at enrollment; lived in the U.S. or its territories; were not known to be HIV-positive; had a gender identity other than cisgender female; and met at least one of the following additional criteria: diagnosed with syphilis in the past 12 months, diagnosed with rectal gonorrhea/chlamydia in the past 12 months, shared injection drug use needles in the past 12 months, self-reported more than one receptive condomless anal sex (CAS) act with a man in the past 3 months, self-reported greater than two insertive CAS acts with a man in the past 3 months, took post-exposure prophylaxis (PEP) in the past 12 months, and/or self-reported methamphetamine use in the past 3 months. These eligibility criteria were informed by CDC recommendations for PrEP treatment, our Scientific Advisory Board, and data-driven by information on factors associated with HIV seroconversion from the NYC Department of Health and Mental Hygiene’s Sexual Health clinics.
During their 24-month survey, participants were presented with two ads exactly as they appeared on social media. One ad read “Gilead TDF HIV Drugs Lawsuit: Lawsuits allege that Gilead Sciences withheld a less toxic HIV drug in order to maximize profits. In 2017, drugs like Truvada earned Gilead $11 billion.” The other ad read “Warning: Kidney disease, bone loss or breaks, tooth loss and osteoporosis linked to Truvada. Victims and their families may be owed compensation if diagnosed after 2004. No cost or obligation review, only takes 60 seconds.”
Participants were first asked if they had seen ads like these on social media (1 = yes, 0 = no). Next, and regardless of whether participants had seen these types of ads or not, participants were asked two questions about how seeing the ads would impact their decisions to start and stay on PrEP (Truvada). Phrasing varied for participants who reported currently taking PrEP (i.e., on PrEP at month 24) compared to those not on PrEP at the time, as indicated by the brackets below:
“[When you were first deciding to go on PrEP (Truvada)], how much would seeing an ad like this impact your decision to start PrEP (Truvada)?”
“[If you were on PrEP (Truvada)], how much would seeing an ad like this impact your decision to stay on PrEP (Truvada)?”
The answer choices for both of these questions were (original emphasis): I definitely would NOT [start/stay on] PrEP, I probably would NOT [start/stay on] PrEP, I am not sure whether I would [start/stay on] PrEP or not, I probably would [start/stay on] PrEP, I definitely would [start/stay on] PrEP. These categories were recoded to (definitely or probably) would start/stay on PrEP, not sure, and (definitely or probably) would not start/stay on PrEP.
Following these questions, participants were asked the extent to which they agreed—strongly agree, agree, neutral, disagree, strongly disagree—with the following statement, “Ads like this make me think PrEP (Truvada) is not safe.” These answers were then recoded to three categories: (strongly) agree, neutral, and (strongly) disagree.
Participants also reported on their survey their race or ethnicity (coded White, Black, Latinx, All other), gender identity (which we coded into cisgender male and transgender/nonbinary), and location of residence (which was coded into regions: Northeast, Midwest, South, West, and US. Territory/Possession). Given the small sample size for transgender/non-binary individuals, we are unable to statistically compare, for example, transgender men (n = 13) versus transgender women (n = 13) and the n = 28 participants who identified as gender non-binary (assigned male sex at birth). Our analyses could compare, however, how transgender/non-binary individuals as a group differed from cisgender gay and bisexual men.
We also created a variable based on participants report of PrEP use across study assessments (e.g., never taken PrEP; PrEP use greater than 1 year ago; PrEP use in the past year; or currently on PrEP at time of 24-month assessment). For those having taken PrEP in the past year, we assessed which formulations of PrEP they had taken (TDF only, TAF only, both TDF and TAF). Finally, based on participant’s reported behavior at 24-month assessment, we estimated if participants would meet objective criteria for PrEP treatment (defined as having two or more acts of insertive CAS, one or more acts of receptive CAS, or sex with an HIV-positive partner in the last 3 months; having used methamphetamine in the past year; and/or reporting an STD in the past year).13
Analysis Plan
We use descriptive statistics—means, standard deviations, frequencies, and percentages—to describe participants age, race/ethnicity, gender identity, U.S. Census region of residence at 24 months, experiences with PrEP, and PrEP eligibility at month 24, as appropriate. Chi-squared tests of differences were used to determine associations between categorical demographic or behavioral factors with each of the TDF lawsuit questions: having seen the ads, impact of perceived safety of PrEP; and impacts on decisions to start or stay on PrEP. Fisher exact tests were used as needed due to small sample sizes. To determine associations of the multilevel, categorical dependent variable with the continuous independent variable of age, we conducted bivariate multilevel logistic regression analyses for each outcome of interest and participant’s age (sole predictor). We report the Chi-squared test statistics (or Wald Chi-Squared as appropriate) and p-values associated for all tests. All analyses were completed using SAS 9.4.
RESULTS
Participants in this analysis were 32.2 years old on average (range = 18-51; 16.5% were between the ages of 18-24). Just over half were white (51%); however, the sample also included 11.2% Black, 26.2% Latinx, and 11.6% persons of other races and ethnicities (Table 1). Nearly all participants identified as cisgender men (97.5%), however, the sample also included n = 11 trans women, n = 13 trans men, and n = 28 who identified as gender non-binary (assigned male sex at birth). One-fifth (20.1%) of participants reported they were currently taking PrEP at the time of assessment and an additional 7.7% reported using PrEP in the past year (but were not taking it at the time of assessment). Among those who reported any current or past-year PrEP use (n = 576), 83.9% reported using TDF-only, 9% reported using TAF-only, and 7.2% reported having used both TDF and TAF (i.e., had switched between the drugs). A majority (60.9%) of participants reported no history of PrEP use. Of these participants (n = 1,265), the vast majority (90.2%) reported behaviors on their 24-month survey that would objectively indicate they were eligible for PrEP (i.e., a key population for PrEP uptake).
Table 1.
Associations of select demographic and behavioral characteristics with having seen a Truvada lawsuit advertisement and impact of adverstisement on attitudes toward PrEP safety, Together 5,000 , 2019-2020 (n = 2,078)
| Total completed at 24 months | Reported Seeing Ads | “Ads like this make me think PrEP (Truvada) is not safe” | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n = 2078 | Yes n = 1245 |
No n = 745 |
I don’t know n = 88 |
(Strongly) Agree n = 794 |
Neutral n = 724 |
(Strongly) Disagree n = 560 |
||||||||||||||
| Mean | (SD) | Mean | (SD) | Mean | (SD) | Mean | (SD) | DF | Chi-squared | p | Mean | (SD) | Mean | (SD) | Mean | (SD) | DF | Chi-squared | p | |
| Age | 32.2 | 8.0 | 32.9 | 7.9 | 31.0 | 7.9 | 32.0 | 8.5 | 2 | 25.22 | <0001 | 32.4 | 8.1 | 32.3 | 8.1 | 31.8 | 7.6 | 2 | 2.34 | 0.31 |
| Frequency | (Col %) | Freq | (Row %) | Freq | (Row %) | Freq | (Row %) | DF | Chi-squared | p | Freq | (Row %) | Freq | (Row %) | Freq | (Row %) | DF | Chi-squared | p | |
| Race/ethnicity | 6 | 17.94 | 0.01 | 6 | 17.56 | 0.01 | ||||||||||||||
| White | 1060 | 51.0 | 640 | 60.4 | 378 | 35.7 | 42 | 4.0 | 367 | 34.6 | 390 | 36.8 | 303 | 28.6 | ||||||
| Black | 233 | 11.2 | 160 | 68.7 | 64 | 27.5 | 9 | 3.9 | 92 | 39.5 | 91 | 39.1 | 50 | 21.5 | ||||||
| Latinx | 544 | 26.2 | 323 | 59.4 | 194 | 35.7 | 27 | 5.0 | 231 | 42.5 | 168 | 30.9 | 145 | 26.7 | ||||||
| Other or multiple races/ethnicities | 241 | 11.6 | 122 | 50.6 | 109 | 45.2 | 10 | 4.2 | 104 | 43.2 | 75 | 31.1 | 62 | 25.7 | ||||||
| Gender | 2 | 2.88 | 0.24 | 2 | 2.15 | 0.34 | ||||||||||||||
| Cisgender male | 2026 | 97.5 | 1216 | 60.0 | 727 | 35.9 | 83 | 4.1 | 778 | 38.4 | 701 | 34.6 | 547 | 27.0 | ||||||
| Transgender/non-binary | 52 | 2.5 | 29 | 55.8 | 18 | 34.6 | 5 | 9.6 | 16 | 30.8 | 23 | 44.2 | 13 | 25.0 | ||||||
| U.S. Census Region | 8 | 9.74 | 0.28 | 8 | 7.84 | 0.45 | ||||||||||||||
| Northeast | 230 | 11.1 | 143 | 62.2 | 74 | 32.2 | 13 | 5.7 | 95 | 41.3 | 71 | 30.9 | 64 | 27.8 | ||||||
| Midwest | 269 | 13.0 | 166 | 61.7 | 97 | 36.1 | 6 | 2.2 | 103 | 38.3 | 88 | 32.7 | 78 | 29.0 | ||||||
| South | 1175 | 56.5 | 701 | 59.7 | 418 | 35.6 | 56 | 4.8 | 430 | 36.6 | 437 | 37.2 | 308 | 26.2 | ||||||
| West | 395 | 19.0 | 231 | 58.5 | 151 | 38.2 | 13 | 3.3 | 162 | 41.0 | 126 | 31.9 | 107 | 27.1 | ||||||
| U.S. Possession | 9 | 0.4 | 4 | 44.4 | 5 | 55.6 | 0 | 0.0 | 4 | 44.4 | 2 | 22.2 | 3 | 33.3 | ||||||
| Experiences with PrEP | 6 | 62.79 | <.0001 | 6 | 60.80 | <.0001 | ||||||||||||||
| No history of PrEP | 1265 | 60.9 | 673 | 53.2 | 527 | 41.7 | 65 | 5.1 | 520 | 41.1 | 469 | 37.1 | 276 | 21.8 | ||||||
| History of PrEP > 1 year ago | 237 | 11.4 | 166 | 70.0 | 63 | 26.6 | 8 | 3.4 | 99 | 41.8 | 72 | 30.4 | 66 | 27.9 | ||||||
| History of PrEP in the past year | 159 | 7.7 | 110 | 69.2 | 44 | 27.7 | 5 | 3.1 | 59 | 37.1 | 52 | 32.7 | 48 | 30.2 | ||||||
| Current PrEP use | 417 | 20.1 | 296 | 71.0 | 111 | 26.6 | 10 | 2.4 | 116 | 27.8 | 131 | 31.4 | 170 | 40.8 | ||||||
| History with types of PrEP† | 4 | 8.28 | 0.32* | 4 | 1.63 | 0.80 | ||||||||||||||
| TDF only | 478 | 83.9 | 332 | 69.5 | 131 | 27.4 | 15 | 3.1 | 144 | 30.1 | 154 | 32.2 | 180 | 37.7 | ||||||
| TAF only | 51 | 9.0 | 42 | 82.4 | 9 | 17.7 | 0 | 0.0 | 18 | 35.3 | 14 | 27.5 | 19 | 37.3 | ||||||
| Both TDF and TAF | 41 | 7.2 | 29 | 70.7 | 12 | 29.3 | 0 | 0.0 | 10 | 24.4 | 13 | 31.7 | 18 | 43.9 | ||||||
| Currently meet criteria for PrEP indication | 2 | 8.82 | 0.01 | 2 | 0.97 | 0.62 | ||||||||||||||
| No | 160 | 7.7 | 79 | 49.4 | 75 | 46.9 | 6 | 3.8 | 63 | 39.4 | 59 | 36.9 | 38 | 23.8 | ||||||
| Yes | 1907 | 92.3 | 1158 | 60.7 | 667 | 35.0 | 82 | 4.3 | 726 | 38.1 | 661 | 34.7 | 520 | 27.3 | ||||||
Fisher’s Exact Test
Overall, 59.9% of participants reported having seen TDF-related lawsuits on social media. Significant differences in reports of seeing these ads varied by age, race/ethnicity, experiences with PrEP, and whether or not they currently met objective criteria for PrEP (Table 1). Participants who were older, identified as Black or African American, and met objective criteria for PrEP were more likely to have seen the lawsuit ads, while participants who identified as multi-racial or a race/ethnicity other than White, Black or Latinx and who reported no former PrEP use were less likely to have seen the ads.
The question, in which participants were shown examples of the TDF-related lawsuit ads, was followed by two questions assessing the impact these ads potentially had on starting and staying on PrEP (Table 2). Over one-quarter (27.7%) reported that these ads would negatively impact their decisions to start PrEP (i.e., definitely or probably would not begin PrEP), and an additional 41.8% reported that they were unsure if they would still start PrEP after viewing the ads. Factors significantly associated with varying impacts on decisions to start PrEP as a result of viewing the ads were race/ethnicity and experience with PrEP. Participants who identified as Latinx were significantly more likely to report that they would not start PrEP after seeing the lawsuit ads, while participants who were currently using PrEP or had any former PrEP use were more likely to report that they would start PrEP despite the ads. Similarly, just over one-fifth (22.1%) of participants reported that these ads would negatively impact their decision to stay on PrEP, 40.4% reported that they (definitely or probably) would stay on PrEP despite these ads. Factors that related to how the TDF-related lawsuit ads influenced participants’ decisions to remain on PrEP were age, race/ethnicity, and experience with PrEP. Older participants were less likely to report that seeing the ads would negatively impact their decision to stay on PrEP. Participants who identified as Latinx or as multi-racial/a race/ethnicity other than White, Black or Latinx were more likely to report that they would not stay on PrEP. Additionally, participants currently using PrEP or who had used PrEP in the past year were more likely to report that they would remain on PrEP despite seeing the ads.
Table 2.
Associations of select demographic and behavioral characteristics with impact of adverstisement on deciding to start or stay on PrEP, Together 5,000 , 2019-2020 (n = 2,078)
| How much would seeing an ad like this impact your decision to start PrEP? | How much would seeing an ad like this impact your decision to stay on PrEP? | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (Definitely or Probably) Would start PrEP n = 634 |
Not sure n = 868 |
(Definitely or Probably) Would Not start PrEP n = 576 |
(Definitely or Probably) Would stay on PrEP n = 840 |
Not sure n = 778 |
(Definitely or Probably) Would Not stay on PrEP n = 460 |
|||||||||||||
| Mean | (SD) | Mean | (SD) | Mean | (SD) | DF | Chi-squared | p | Mean | (SD) | Mean | (SD) | Mean | (SD) | DF | Chi-squared | p | |
| Age | 32.0 | 7.7 | 32.4 | 8.3 | 32.1 | 7.7 | 2 | 1.00 | 0.61 | 32.1 | 7.7 | 32.7 | 8.3 | 31.5 | 7.8 | 2 | 5.97 | 0.05 |
| Freq | (Row %) | Freq | (Row %) | Freq | (Row %) | Chi-squared | p | Freq | (Row %) | Freq | (Row %) | Freq | (Row %) | Chi-squared | p | |||
| Race/ethnicity | 6 | 18.48 | 0.01 | 6 | 33.27 | <.0001 | ||||||||||||
| White | 326 | 30.8 | 476 | 44.9 | 258 | 24.3 | 442 | 41.7 | 430 | 40.6 | 188 | 17.7 | ||||||
| Black | 63 | 27.0 | 99 | 42.5 | 71 | 30.5 | 83 | 35.6 | 94 | 40.3 | 56 | 24.0 | ||||||
| Latinx | 163 | 30.0 | 202 | 37.1 | 179 | 32.9 | 218 | 40.1 | 168 | 30.9 | 158 | 29.0 | ||||||
| Other or multiple races/ethnicities | 82 | 34.0 | 91 | 37.8 | 68 | 28.2 | 97 | 40.3 | 86 | 35.7 | 58 | 24.1 | ||||||
| Gender | 2 | 0.44 | 0.80 | 2 | 0.08 | 0.96 | ||||||||||||
| Cisgender male | 616 | 30.4 | 848 | 41.9 | 562 | 27.7 | 818 | 40.4 | 759 | 37.5 | 449 | 22.2 | ||||||
| Transgender/non-binary | 18 | 34.6 | 20 | 38.5 | 14 | 26.9 | 22 | 42.3 | 19 | 36.5 | 11 | 21.2 | ||||||
| U.S. Census Region | 8 | 5.72 | 0.68 | 8 | 6.29 | 0.62 | ||||||||||||
| Northeast | 66 | 28.7 | 90 | 39.1 | 74 | 32.2 | 95 | 41.3 | 83 | 36.1 | 52 | 22.6 | ||||||
| Midwest | 78 | 29.0 | 113 | 42.0 | 78 | 29.0 | 102 | 37.9 | 112 | 41.6 | 55 | 20.5 | ||||||
| South | 367 | 31.2 | 499 | 42.5 | 309 | 26.3 | 473 | 40.3 | 443 | 37.7 | 259 | 22.0 | ||||||
| West | 119 | 30.1 | 162 | 41.0 | 114 | 28.9 | 165 | 41.8 | 139 | 35.2 | 91 | 23.0 | ||||||
| U.S. Possession | 4 | 44.4 | 4 | 44.4 | 1 | 11.1 | 5 | 55.6 | 1 | 11.1 | 3 | 33.3 | ||||||
| Experiences with PrEP | 6 | 140.58 | <.0001 | 6 | 201.70 | <.0001 | ||||||||||||
| No history of PrEP | 279 | 22.1 | 595 | 47.0 | 391 | 30.9 | 395 | 31.2 | 535 | 42.3 | 335 | 26.5 | ||||||
| History of PrEP > 1 year ago | 73 | 30.8 | 89 | 37.6 | 75 | 31.7 | 83 | 35.0 | 97 | 40.9 | 57 | 24.1 | ||||||
| History of PrEP in the past year | 64 | 40.3 | 58 | 36.5 | 37 | 23.3 | 75 | 47.2 | 47 | 29.6 | 37 | 23.3 | ||||||
| Current PrEP use | 218 | 52.3 | 126 | 30.2 | 73 | 17.5 | 287 | 68.8 | 99 | 23.7 | 31 | 7.4 | ||||||
| History with types of PrEP† | 4 | 2.58 | 0.63 | 4 | 1.01 | 0.91 | ||||||||||||
| TDF only | 236 | 49.4 | 153 | 32.0 | 89 | 18.6 | 305 | 63.8 | 121 | 25.3 | 52 | 10.9 | ||||||
| TAF only | 25 | 49.0 | 14 | 27.5 | 12 | 23.5 | 31 | 60.8 | 12 | 23.5 | 8 | 15.7 | ||||||
| Both TDF and TAF | 20 | 48.8 | 16 | 39.0 | 5 | 12.2 | 26 | 63.4 | 10 | 24.4 | 5 | 12.2 | ||||||
| Currently meet criteria for PrEP indication | 2 | 2.52 | 0.28 | 2 | 4.07 | 0.13 | ||||||||||||
| No | 40 | 25.0 | 73 | 45.6 | 47 | 29.4 | 53 | 33.1 | 69 | 43.1 | 38 | 23.8 | ||||||
| Yes | 589 | 30.9 | 793 | 41.6 | 525 | 27.5 | 783 | 41.1 | 705 | 37.0 | 419 | 22.0 | ||||||
Fisher’s Exact Test
Of those reporting PrEP use in the past year
Finally, we asked participants how much they agreed or disagreed (vs. neutral) with the statement “Ads like this make me think PrEP (Truvada) is not safe.” Only 26.9% (strongly) disagreed with the statement (i.e. indicating that they thought PrEP was safe despite the ads). Thirty-eight percent (38.2%) agreed or strongly agreed with the statement. Again, the factors associated with varying levels of agreement with this statement were race and prior experiences taking PrEP. Compared to participants who neither agreed nor disagreed with the safety statement, participants who identified as Latinx, as multi-racial or a racial/ethnic group other than White, Black or Latinx were more likely to report that they agreed with the statement indicating that TDF was unsafe. Participants who reported current PrEP use or any former PrEP use were more likely to disagree with the statement indicating TDF being unsafe.
DISCUSSION
Community groups, researchers, and providers have been raising alarms that ads for lawsuits that perpetuate rare side effects caused by TDF/FTC may be hindering progress to disseminate PrEP in the communities most heavily impacted by HIV. However, to our knowledge, there have been no empirical studies to investigate this. In our geographically diverse sample of participants in an ongoing cohort study, we observed that 59.9% had seen ads for TDF lawsuits on their social media. And, more alarming, 38.2%, said that seeing lawsuit ads made them question the safety of PrEP.
Those with experience taking PrEP expressed less trepidation due to these ads, which may be related to not having experienced the negative outcomes these ads portend. Nevertheless, we note that 27.8% of participants currently using PrEP and 37.1% of those who reported using PrEP in the past year reported that these lawsuit ads made them think PrEP is not safe. Alarmingly, large proportions of participants who had no experience on PrEP reported that these ads would impact their decisions to start or stay on PrEP. Since the majority of participants not on PrEP reported behaviors indicating that they might be appropriate candidates for PrEP, this provides concerning evidence of the negative impacts of these ads may be having on PrEP uptake among key populations.
Next, we also found differential impacts by racial and ethnic groups. Although not consistent in every set of analyses reported in Tables 1 and 2, the overall trend was such that Black, Latinx, and/or multiracial individuals were most likely to be negatively impacted by the ads compared with white participants. Black and Latinx individuals are disproportionally impacted by HIV compared to whites, and thus represent key populations that would benefit from PrEP’s protection. Our findings suggest these ads may be undermining, if not out-right reversing, efforts to disseminate PrEP to those most vulnerable to HIV.
Limitations
Our results should be understood in light of their limitations. Our measures were self-reported and participants were responding to questions about how they think they may change their behavior, as opposed to having actually changed their behavior (i.e., quit PrEP as a result of seeing an ad). We also lack nuance on things like whether the ads may have impacted other facets of the PrEP care continuum (e.g., intentionally skipping doses out of belief that this would reduce toxicity; willingness to talk to a provider about PrEP). We did not collect data on the frequency with which participants had seen these ads nor the exact sources (e.g., Facebook versus other forms of social media). We did not collect data on overall patterns of social media use or overall perceptions of trust in content from social media. Also, our analyses do not include all members of the cohort. Participants are being invited to complete this assessment approximately 24 months after they joined the study and those invitations will extend into summer 2020. Given the uptick of community based and public health attention turning to this topic, its likely there may be some observed effects these ads may have over time. We will be able to assess this in the future both in terms of within the month 24 assessments (i.e., did participants we surveyed in fall 2019 differ in their responses from those surveyed in summer 2020) as well as in future waves of assessment (i.e. 36 month and 48 month).
Next, we recognize that our cohort is comprised of an internet-based sample recruited on geosocial networking apps. Not all sexual and gender minority individuals use these apps and we also recognize there is the potential for fraudulent participants in online studies. However, multiple efforts were taken to prevent this. This included advertising only to participants geolocated in the U.S., links that expired after one click, blocking multiple submissions from a given IP address, and requiring unique and valid mailing addresses for HIV test kits to be mailed. Finally, our sample is predominantly cis men who have sex with men. We lack sufficient power to assess the effects these ads may be having on transgender and non-binary participants, a group that is also at exceptional risk for HIV.
Conclusion
Due to forthcoming affordable/generic options, TDF/FTC is likely to become the most scalable option for disseminating PrEP to key populations. Our results suggest that ads for TDF lawsuits on social media are having a deleterious impact on individual PrEP decision-making, including perceptions of PrEP’s safety. Our findings provide initial evidence of this impact and highlight the urgency for future researchers to assess how these ads may be impacting a full PrEP care continuum. These findings also indicate the urgency for accurate and balanced messaging on the benefits and risks of PrEP, so that individuals can make informed choices about whether PrEP is right for them.
Acknowledgements:
The authors would like to acknowledge members of the T5K: Sarit A. Golub, Don Hoover, Greg Millett, Viraj V. Patel David Pantalone, Sarah Kulkarni, Matthew Stief, Chloe Mirzayi, Gloria Perez, Corey Morrison, Pedro Carneiro, and Javier Lopez-Rios. They also thank the program staff at National Institutes of Health: Gerald Sharp, Sonia Lee, and Michael Stirratt; and the members of our Scientific Advisory Board: Michael Camacho, Adam Carrico, Sabina Hirshfield, Claude Mellins, and Milo Santos.
Funding: Together 5,000 was funded by the National Institutes for Health (UG3 AI 133675 - Principal Investigator: C.G.). 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)
Footnotes
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