Reported Pre-exposure Prophylaxis Use Research Articles

Related barriers to using HIV pre-exposure prophylaxis among MSM: A multicentre cross-sectional survey.

The objective of this study was to gain insight into the barriers hindering the use of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in five cities in China. MSM were recruited via community-based organizations in an online "snowball" manner. Participants completed the questionnaire anonymously and shared it with key MSM peers (seeds) in five cities in China. Based on the results of univariate analysis, we used a structural equation model to analyse the role of PrEP knowledge awareness, PrEP counselling, and other behavioural variables on PrEP use. The study collected a total of 4223 valid questionnaires, and 18.2% of participants reported PrEP use. The results of the standardized total effects showed that the following paths were statistically significant (p < 0.05): from the age of first sex with men to PrEP knowledge awareness (β = -0.113) and PrEP use (β = 0.042); from high-risk sexual behaviour scores to PrEP counselling (β = 0.039) and PrEP use (β = 0.103); from the number of HIV tests in the last year to PrEP knowledge awareness (β = 0.034), PrEP counselling (β = 0.170), and PrEP use (β = 0.197); from the level of self-perceived risk of HIV infection to PrEP counselling (β = -0.115); from PrEP knowledge awareness to PrEP use (β = -0.049); and from PrEP counselling to PrEP use (β = 0.420). The proportion of PrEP use among MSM was relatively low. Age at first sex with men, number of HIV tests, high-risk sexual behaviour, and PrEP counselling had a positive effect on PrEP use, whereas PrEP knowledge awareness had an inverse effect on PrEP use.

Changes in Cost and Insurance Challenges to Cover PrEP Between 2019 and 2021.

Pre-Exposure Prophylaxis (PrEP) use continues lag estimated need among gay and bisexual men in the United States. Studies report that challenges paying for PrEP may undermine continued use. Our study aimed to measure these challenges over time. Data were taken from a US national cohort study of cisgender gay and bisexual men and transgender individuals aged 16-49 years. We analyzed data from PrEP-using participants between 2019 and 2021 and observed cost-related and insurance-related challenges participants experienced while on PrEP across time points. We report McNemar and Cochrane Q test statistics to compare differences between groups by year(s). In 2019, 16.5% (n = 828/5013) of participants were on PrEP; by 2020, 21% (n = 995/4727) were on PrEP, and by 2021, 24.5% (n = 1133/4617) were on PrEP. The proportion of those experiencing challenges paying for PrEP care decreased significantly across time points for clinical appointments, laboratory work, and prescriptions. Those experiencing insurance and copay approval issues did not change significantly. Although not statistically significant, the only proportion that increased over time was those reporting PrEP-related insurance approval issues. In a post hoc analysis, we found that those reporting PrEP use in the past year who were not currently on PrEP were significantly more likely to report experiencing most PrEP challenges, when compared with current PrEP users. We found significant reductions in insurance and cost-related challenges between 2019 and 2021. However, those who discontinued PrEP within the past year reported greater challenges paying for PrEP, suggesting that cost and insurance issues may undermine PrEP persistence.

Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in South African women: a cohort study.

Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV acquisition. However, prevention effectiveness requires daily adherence prior to and during periods of sexual activity. Little is known about pharmacologic measures of PrEP adherence during pregnancy and postpartum and the factors related to optimal adherence during periods of sexual activity in this population. Between August 2019 and October 2021, we enrolled pregnant women without HIV at their first antenatal care visit followed-up through 12 months postpartum. Eligible women ≥16 years old received HIV prevention counselling and were offered oral PrEP (TDF-FTC). We quantified tenofovir-diphosphate (TFV-DP) in dried blood spots in women who reported taking PrEP in the past 30 days (at quarterly follow-up visits). We used regression models with generalized estimating equations to evaluate correlates of TFV-DP (any vs. none, and ≥2 vs. <2 doses/week), adjusting for maternal age and pregnancy status. In 382 women who started PrEP in pregnancy, returned for follow-up and reported PrEP use in the past 30 days, the median age was 27 years (interquartile range [IQR] = 23-32), and the median time on PrEP was 168 days (IQR = 84-252 days). Half of the samples had quantifiable TFV-DP at any time point (52%), declining from 67% of pregnant women 3 months post-initiation to 31% of postpartum women by 12 months. Overall, 72% had concentrations corresponding to <2 doses/week; 25% ≥2 doses/week; 3% 7 doses/week. Concentrations were lower in postpartum versus pregnancy (age-adjusted odds ratio [aOR] = 0.44; 95% confidence interval [CI] = 0.35-0.54). The correlation of self-reported adherence and TFV-DP ranged from -0.07 in pregnancy to 0.25 in postpartum women. Variables associated with having quantifiable TFV-DP included partner living with HIV/unknown serostatus (aOR = 1.50; 95% CI = 1.01-2.22), and reported frequency of sexual activity in the past month (aOR sex >5/month vs. no sex or <5 times/month = 2.11; 95% CI = 1.58-2.82) adjusting for age and pregnancy versus postpartum status. TFV-DP concentrations declined over follow-up time (aOR for 6 vs. 3 months = 0.49; 95% CI = 0.36-0.67). Objectively measured adherence to PrEP was low overall and did not correlate with self-reported use. There is an urgent need for objective adherence measures to support clinical decision-making as well as adherence support interventions as part of PrEP services for pregnant and postpartum women at risk of HIV.

Engagement With HIV and COVID-19 Prevention: Nationwide Cross-sectional Analysis of Users on a Geosocial Networking App.

BackgroundGeosocial networking (GSN) apps play a pivotal role in catalyzing sexual partnering, especially among men who have sex with men.ObjectiveTo quantify the prevalence and disparities in disclosure of pre-exposure prophylaxis (PrEP) use and COVID-19 vaccination among GSN app users, mostly men who have sex with men, in the United States.MethodsWeb-based Grindr profiles from the top 50 metropolitan areas as well as the 50 most rural counties in the United States by population were randomly sampled. Grindr provides an option to disclose current PrEP use (HIV positive, HIV negative, or HIV negative with PrEP use). The free text in all profiles was analyzed, and any mention of COVID-19 vaccination was recorded. Multivariable logistic regression to assess independent associations with PrEP disclosure and COVID-19 vaccination was performed. Imputation analyses were used to test the robustness of the results.ResultsWe evaluated 1889 urban and 384 rural profiles. Mean age among urban profiles was 32.9 (SD 9.6) years; mean age among rural profiles was 33.5 (SD 12.1) years (P=.41). Among the urban profiles, 16% reported being vaccinated against COVID-19 and 23% reported PrEP use compared to 10% and 8% in rural profiles, respectively (P=.002 and P<.001, respectively). Reporting COVID-19 vaccination (adjusted odds ratio [aOR] 1.7, 95% CI 1.2-2.4), living in an urban center (aOR 3.2, 95% CI 1.8-5.7), and showing a face picture as part of the Grindr profile (aOR 4.0, 95% CI 2.3-7.0) were positively associated with PrEP disclosure. Self-identified Black and Latino users were less likely to report PrEP use (aOR 0.6, 95% CI 0.4-0.9 and aOR 0.5, 95% CI 0.4-0.9, respectively). Reporting PrEP use (aOR 1.7, 95% CI 1.2-2.4), living in an urban center (aOR 2.5, 95% CI 1.4-4.5), having a “discreet” status (aOR 1.6, 95% CI 1.0-2.5), and showing a face picture (aOR 2.7, 95% CI 1.5-4.8) were positively associated with reporting COVID-19 vaccination on their profile. Users in the southern United States were less likely to report COVID-19 vaccination status than those in the northeast United States (aOR 0.6, 95% CI 0.3-0.9).ConclusionsVariations in PrEP disclosure are associated with race, whereas COVID-19 vaccination disclosure is associated with geographic area. However, rural GSN users were less likely to report both PrEP use and COVID-19 vaccination. The data demonstrate a need to expand health preventative services in the rural United States for sexual minorities. GSN platforms may be ideal for deployment of preventative interventions to improve access for this difficult-to-reach population.

Trends in preexposure prophylaxis use among sex partners as reported by persons with HIV - United States, May 2015-June 2020.

To estimate trends in the proportion of sexually active U.S. adults with HIV (PWH) reporting an HIV-discordant sexual partner taking preexposure prophylaxis (PrEP) and proportion of partners taking PrEP. The Medical Monitoring Project is a complex sample survey of U.S. adults with diagnosed HIV. We used annual cross-sectional data collected during June 2015-May 2020 to estimate the annual percentage change (EAPC), overall and by selected characteristics, in reported partner PrEP use among PWH with HIV-discordant partners (N = 8707) and reported PrEP use among these partners (N = 15 844). The proportion of PWH reporting PrEP use by one or more HIV-discordant sex partner rose 19.5% annually (11.3 to 24.4%). The prevalence rose from 6.0 to 17.4% (EAPC, 25.8%) among Black PWH, 10.1 to 26.0% (EAPC, 19.5%) among Hispanic/Latino PWH, and 20.8 to 34.6% (EAPC, 16.3%) among White PWH. Among MSM with HIV, the prevalence increased from 9.6 to 32.6% (EAPC, 28.2%) among Black MSM, 16.6 to 36.0% (EAPC, 15.6%) among Hispanic/Latino MSM, and 24.9 to 44.1% (EAPC, 17.9%) among White MSM. Among HIV-discordant sex partners, the proportion reported to be taking PrEP increased 21.1% annually (7.8 to 18.8%). Reported PrEP use rose from 4.9 to 14.2% (EAPC, 29.9%) among Black partners, 6.5 to 16.8% (EAPC, 20.3%) among Hispanic/Latino partners, and 12.7 to 26.1% (EAPC, 17.0%) among White partners. One in five HIV-discordant sexual partners of PWH was reported to be taking PrEP. PrEP use rose among all examined populations, although the increases did not eliminate disparities in PrEP use.

Prevalence and Risk Factors of PrEP Use Stigma Among Adolescent Girls and Young Women in Johannesburg, South Africa and Mwanza, Tanzania Participating in the EMPOWER Trial

Adolescent girls and young women (AGYW) in sub-Saharan Africa may benefit from pre-exposure prophylaxis (PrEP), yet stigma may limit PrEP acceptance and continuation. We examined factors associated with PrEP use stigma among 307 participants of the EMPOWER trial (2016–2018), an unblinded randomized controlled trial among HIV-negative, AGYW, aged 16–24, in South Africa and Tanzania. The 6-item, brief-PrEP use stigma scale (B-PSS) had high internal reliability. At the end of the trial, 34.2% of study participants reported any PrEP use stigma. Three latent classes were observed, reflecting low (46.9%), medium (31.9%), and high (21.2%) reported PrEP use stigma. Disclosure of PrEP use to sexual partner and belief that PrEP prevents HIV were associated with less reported PrEP use stigma. Conversely, participants who reported fear and shame about people living with HIV were more likely to report PrEP use stigma. Our validated tool and findings will enable practitioners to identify AGYW at high risk of PrEP use stigma who may benefit from additional support.Pan African clinical trials registry PACTR202006754762723, 5 April 2020, retrospectively registered.

Pre-exposure prophylaxis (PrEP) use, anticipated PrEP stigma, and bisexual identity among a Black and Hispanic/Latino sexual and gender diverse sample

Black and Hispanic/Latino sexual minority men and gender diverse (SMMGD) individuals are disproportionately impacted by the HIV epidemic. Uptake and adherence to pre-exposure prophylaxis (PrEP) is suboptimal among SMMGD Black and Hispanic/Latino individuals, but most research has approached this population as homogenous (e.g., a group operationalized as men who have sex with men). Bisexual men are less likely to disclose their sexual identity and report more mental health problems than their gay counterparts, but there is less attention to the impact of different sexual identities on PrEP use over time. We utilized data from three waves of a national longitudinal study (2020-2021) to characterize Black and Hispanic/Latino SMMGD participants’ PrEP use including: 1) PrEP uptake during the study; 2) consistent PrEP use across the study; and 3) discontinuation of PrEP use since study baseline. We found bisexual men were significantly less likely than gay men to be consistent PrEP users and were more likely to discontinue PrEP use over the course of the study. Of the sample who reported PrEP use across surveys, 10% initiated PrEP during the study period, 0% of whom were bisexual. Additionally, bisexual participants reported statistically significantly higher anticipated PrEP stigma relative to gay participants. These findings have implications for HIV prevention interventions. Given the differences in PrEP experiences as a function of sexual identity, researchers and clinicians should consider the disruptive role of stigma (both biphobia and anticipated PrEP stigma) in PrEP care and adherence.

Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study.

SummaryBackgroundAs oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial's last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment.MethodsWe did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16–35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067.Findings2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2·16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4·65%) before PrEP access (adjusted incidence rate ratio [IRR] 0·45, 95% CI 0·25–0·82, p=0·0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5·00 vs 2·29 per 100 person-years; IRR 0·43, 95% CI 0·22–0·88, p=0·012).InterpretationOn-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women.FundingBill & Melinda Gates Foundation, United States Agency for International Development, President's Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency, South African Medical Research Council, and United Nations Population Fund.

The Pre-Exposure Prophylaxis Cascade in At-Risk Transgender Men Who Have Sex with Men in the United States

Purpose: This analysis was designed to characterize the pre-exposure prophylaxis (PrEP) cascade in a U.S. national sample of transgender men and trans masculine adults who have sex with cisgender men (trans MSM) at-risk for HIV acquisition. Methods: From November to December 2017, 843 HIV-negative trans MSM self-reporting past-6-month receptive sex with a cisgender man were recruited via peer referrals, dating apps, listservs, and social media. A computer-assisted self-interview assessed demographics, health care, and the PrEP cascade. Descriptive statistics and multivariable regression models evaluated factors associated with PrEP uptake and persistence. Results: Mean age was 28.1 years (standard deviation = 7.1); 4.8% were Black, 21.7% Latinx, and 25.6% another race/ethnicity. A total of 84.1% had heard of PrEP, with 67.3% reporting interest. More than half (55.2%) were PrEP indicated, of which 50.8% were PrEP naive. Approximately 1/4 (28.0%) reported PrEP use, of which 65.3% were PrEP persistent. PrEP modality preferences were injectable (51.2%), daily oral pill (22.1%), and anal gel/lube (14.6%). Reasons for PrEP noninterest were no HIV risk (68.5%), cost (24.2%), and side effects (20.1%). Surgical gender affirmation, no health care discrimination, and social media as a primary health information source were associated with increased odds of PrEP uptake and persistence (all p < 0.05). PrEP adherence difficulties were reported by 52.6%, due to busy/inconsistent schedule (53.1%), side effects (27.4%), and too many medical visits (11.6%). Conclusion: PrEP uptake was modest among the trans MSM sampled, given prevalent HIV risk behaviors. The limited PrEP uptake in at-risk trans MSM suggests the need to develop culturally tailored community education and interventions.

Longitudinal trends in PrEP familiarity, attitudes, use and discontinuation among a national probability sample of gay and bisexual men, 2016-2018.

This study explored familiarity with, attitudes toward, uptake and discontinuation of PrEP (Pre-exposure prophylaxis) among a national probability sample of gay and bisexual men. PrEP is one of the most effective biomedical HIV prevention strategies; however, use among gay and bisexual men remains low within the United States. This study used a national probability sample of gay and bisexual men from three age cohorts of men (18–25, 34–41, and 52–59 years at wave 1) who completed three annual surveys between March 2016 and March 2018 (N at wave 1 = 624). Recruitment occurred through a Gallup dual-frame sampling procedure; results for this study came from eligible individuals who consented to be part of the self-administered online or mailed survey questionnaire. We used descriptive data with sampling weights to understand trends in PrEP familiarity, PrEP attitudes and PrEP use across all three time points. Next, PrEP uptake and discontinuation were assessed among men completing all three surveys and who remained eligible for PrEP at all three time points (N = 181). PrEP familiarity increased considerably between 2016 and 2018 among those eligible for PrEP (from 59.8% from wave 1 to 92.0% at wave 3). Favorable attitudes toward PrEP increased more modestly (from 68.3% at wave 1 to 72.7% at wave 3). While PrEP use increased by 90% between the two time points (from 4.1% in 2016 to 7.8% in 2018), this represented a small percentage of overall uptake among eligible participants across time (6.6%). Among respondents who reported PrEP use at wave 1 or wave 2, 33.3% subsequently discontinued PrEP use at a later wave. Findings indicate modest increases in PrEP use between 2016 and 2018 in a national probability sample of sexually-active gay and bisexual men. PrEP discontinuation was high and suggests the need for further research into gay and bisexual men’s PrEP discontinuation and persistence.

High acceptability of PrEP teleconsultation and HIV self-testing among PrEP users during the COVID-19 pandemic in Brazil

In March 2020, telemedicine and HIV self-testing were adopted by Brazilian Public Health services to minimize disruptions in pre-exposure prophylaxis (PrEP) access and delivery during the COVID-19 pandemic. To understand the acceptability of PrEP teleconsultation and HIV self-testing, we conducted a web-based study during social distancing period (April–May, 2020) among men who have sex with men and transgender/non-binary individuals using social media. Out of the 2375 HIV negative respondents, 680 reported PrEP use and were included in this analysis. Median age was 33 years (IQR: 28–40), 98% cisgender men, 56% white, 74% high education, and 68% middle/high income. Willingness to use HIVST was 79% and 32% received an HIV self-testing during social distancing period. The majority reported preference for PrEP/HIV self-testing home delivery instead of collecting at the service. PrEP teleconsultation was experienced by 21% and most reported feeling satisfied with the procedures. High acceptability of PrEP teleconsultation was reported by 70%. In ordinal logistic model, having higher education was associated with high aceptability of PrEP teleconsultation (aOR:1.62; 95%CI: 1.07–2.45). Our results point out that PrEP teleconsultation and PrEP/HIV self-testing home delivery could be implemented by PrEP services in Brazil to avoid PrEP shortage during the COVID-19 pandemic and thereafter as an option to increase retention and adherence.

Pre-exposure Prophylaxis Use and Detected Sexually Transmitted Infections Among Men Who Have Sex With Men in the United States-National HIV Behavioral Surveillance, 5 US Cities, 2017.

Men who have sex with men (MSM) using HIV pre-exposure prophylaxis (PrEP) may be at high risk for bacterial sexually transmitted infections (STIs). We examined the prevalence of extragenital gonorrhea and chlamydia by PrEP status among a multisite sample of US MSM. MSM aged ≥18 years were recruited through venue-based sampling to participate in the 2017 National HIV Behavioral Surveillance. In 5 cities (San Francisco, Washington DC, New York City, Miami, and Houston), participants completed a questionnaire, HIV testing, and pharyngeal and rectal STI specimen self-collection. We measured prevalence of pharyngeal and rectal gonorrhea and chlamydia among self-reported non-HIV-positive MSM who reported using or not using PrEP in the previous 12 months. Overall, 29.6% (481/1627) of non-HIV-positive MSM reported PrEP use in the past year. MSM who reported PrEP use were more likely to have any STI (ie, extragenital gonorrhea and/or chlamydia) than MSM not on PrEP [14.6% vs. 12.0%, adjusted prevalence ratio (aPR) = 1.5, 95% confidence interval (CI) : 1.1 to 2.0], reflecting differences in rectal chlamydia prevalence (8.7% vs. 6.0%, aPR = 1.6, 95% CI: 1.1 to 2.4). PrEP use was not associated with pharyngeal chlamydia, pharyngeal gonorrhea, or rectal gonorrhea. The prevalence of extragenital STI was high for both MSM on PrEP and those not on PrEP in the past year. MSM on PrEP were more likely to have rectal chlamydia but not pharyngeal STIs or rectal gonorrhea. Our findings support regular STI testing at exposed anatomic sites as recommended for sexually active MSM, including those on PrEP.

Substantial Decline in Use of HIV Preexposure Prophylaxis Following Introduction of COVID-19 Physical Distancing Restrictions in Australia: Results From a Prospective Observational Study of Gay and Bisexual Men.

Background:In response to the novel coronavirus disease (COVID-19) pandemic, Australia introduced public health and physical distancing restrictions in late March 2020. We investigated the impact of these restrictions on HIV preexposure prophylaxis (PrEP) use among Australian gay and bisexual men (GBM).Methods:Participants in an ongoing online cohort study previously reported PrEP use from 2014 to 2019. In April 2020, 847 HIV-negative and untested participants completed questionnaires assessing changes in PrEP use as a result of COVID-19 public health measures. Binary logistic multiple regression was used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) to compare changes in PrEP use behaviors.Results:Among 847 men, mean age was 44.1 years (SD: 12.7). PrEP use rose from 4.9% in 2015 to 47.2% in 2020. Among those, 41.8% (n = 167) discontinued PrEP use during COVID-19 restrictions. Discontinuing PrEP during COVID-19 restrictions was independently associated with being less likely to have recently tested for HIV (aOR: 0.17; 95% CI: 0.09 to 0.34; P < 0.001) and less likely to report sex with casual partners (aOR: 0.28; 95% CI: 0.14 to 0.54; P < 0.001).Conclusions:By April 2020, following the introduction of COVID-19 restrictions, GBM dramatically reduced PrEP use, coinciding with a reduction in sexual activity. Longer-term impacts of COVID-19 restrictions on sexual behaviors among GBM need to be monitored because they may foreshadow fluctuations in prevention coverage and risk of HIV infection. Our findings indicate a potential need for clear, targeted information about resumption of PrEP and on-demand optimal dosing regimens in response to ongoing changes in restrictions.

Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial

HIV incidence among adolescents in southern Africa remains unacceptably high. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention but there are few data on its implementation among adolescents. We aimed to investigate the safety, feasibility, and acceptability of PrEP with oral tenofovir disoproxil fumarate and emtricitabine as part of a comprehensive HIV prevention package in an adolescent population in South Africa. This open-label single-arm phase 2 study (PlusPills) was done in two research clinics in Cape Town and Johannesburg, South Africa. Adolescents aged 15-19 years were recruited into the study through recruitment events and outreach in the community. Potential participants were eligible for enrolment if they reported being sexually active. Exclusion criteria were a positive test for HIV or pregnancy at enrolment, breastfeeding, or any relevant co-morbidities. Participants were given oral tenofovir disoproxil fumarate and emtricitabine for PrEP to take daily for the first 12 weeks and were then given the choice to opt in or out of PrEP use at three monthly intervals during scheduled clinic visits. Participants were invited to monthly visits for adherence counselling and HIV testing during the study period. The primary outcomes were acceptability, use, and safety of PrEP. Acceptability was measured by the proportion of participants who reported willingness to take up PrEP and remain on PrEP at each study timepoint. Use was defined as the number of participants who continued to use PrEP after the initial 12-week period until the end of the study (week 48). Safety was measured by grade 2, 3, and 4 laboratory and clinical adverse events using the Division of AIDS table for grading the severity of adult and paediatric adverse events, version 1.0. Dried blood spot samples were collected at each study time-point to measure tenofovir diphosphate concentrations. This trial is registered with ClinicalTrials.gov, NCT02213328. Between April 28, 2015, and Nov 11, 2016, 244 participants were screened, and 148 participants were enrolled (median age was 18 years; 99 participants [67%] were female) and initiated PrEP. PrEP was stopped by 26 of the 148 (18%) participants at 12 weeks. Cumulative PrEP opt-out, from the total cohort, was 41% (60 of 148 participants) at week 24 and 43% (63 of 148 participants) at week 36. PrEP was well tolerated with only minor adverse events (grade 2) thought to be related to study drug, which included headache (n=4, 3%), gastrointestinal upset (n=8, 5%), and skin rash (n=2, 1%). Two participants (1%) experienced grade 3 weight loss, which was deemed related to the study drug and resolved fully when PrEP was discontinued. Tenofovir diphosphate concentrations were detectable (>16 fmol/punch) in dried blood spot samples in 108 (92%) of 118 participants who reported PrEP use at week 12, in 74 (74%) of 100 participants at week 24, and in 22 (59%) of 37 participants by the study end at week 48. In this cohort of self-selected South African adolescents at risk of HIV acquisition, PrEP appears safe and tolerable in those who continued use. PrEP use decreased throughout the course of the study as the number of planned study visits declined. Adolescents in southern Africa needs access to PrEP with tailored adherence support and possibly the option for more frequent and flexible visit schedules. National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.

PrEP Uptake and Discontinuation Among a U.S. National Sample of Transgender Men and Women.

Pre-exposure prophylaxis (PrEP) has revolutionized HIV prevention efforts by effectively preventing the sexual transmission of HIV infection. Few studies have examined PrEP uptake and discontinuation among transgender individuals who are underserved in HIV prevention efforts. An online U.S. nationwide survey screened 294 HIV-negative transgender people for participation in a larger cohort study. We analyzed associations between demographic characteristics and PrEP use and discontinuation. We conducted thematic analyses of open-ended responses to identify reasons for PrEP discontinuation. Fifty-one participants (17.4%) reported ever receiving a PrEP prescription. Transgender men reported higher PrEP use than transgender women (χ2 = 18.06; p < 0.0001). PrEP discontinuation was reported by 49.0% of individuals who reported PrEP use. Reasons for PrEP discontinuation were related to side effects, insurance coverage, relationship status, and access to providers. HIV prevention efforts to increase PrEP should include mechanisms for PrEP uptake and re-initiation among transgender individuals.

Effect of Truvada lawsuit advertising on preexposure prophylaxis attitudes and decisions among sexual and gender minority youth and young adults at risk for HIV.

In 2019, US advocates reported misleading language regarding the safety of TDF/FTC (Truvada) used by lawsuit advertisements against Gilead Sciences. We sought to ascertain the reach and effects of the advertisements on preexposure prophylaxis (PrEP) opinions and decisions in a cohort of youth and young adults at-risk for HIV. An online survey was administered to participants enrolled in Keeping it LITE, a prospective US cohort study of ethnically diverse, sexually active, cisgender and transgender persons ages 13-37. Quantitative data were analyzed using descriptive and inferential analysis in SAS, and qualitative data via thematic analysis. Survey response rate was 51.3% (n = 1485). Mean age at baseline was 24. Previous PrEP use was reported by 43% of respondents and 32.7% reported PrEP use in the past 6 months. Almost half (48.7%) were aware of the lawsuit. Most of these participants (81.3%) reported the advertisements did not impact their PrEP use, but 13.2% decided to not to begin a Truvada-based PrEP regimen and 5.5% decided to stop taking Truvada due to the advertisements claims. Predictors of changing PrEP behavior were lower education and no previous PrEP use. The qualitative analysis revealed the advertisements increased skepticism about safety and benefit of Truvada PrEP and led to greater distrust of the pharmaceutical industry. The advertisements reached a large, diverse US audience. Disturbingly, 18.7% of PrEP candidates who were aware of the lawsuit attributed not initiating or cessation of a Truvada-based PrEP regimen to exposure to the Truvada lawsuit advertisements.

Growth in Proportion and Disparities of HIV PrEP Use Among Key Populations Identified in the United States National Goals: Systematic Review and Meta-analysis of Published Surveys.

Pre-exposure prophylaxis (PrEP) use among populations most vulnerable to HIV as identified in the national HIV prevention goals is not fully known. This systematic review assessed trends of lifetime self-reported PrEP use and disparities among key populations. We used the CDC HIV/AIDS Prevention Research Synthesis cumulative database of electronic and manual searches in MEDLINE, CINAHL, EMBASE, and PsycINFO from 2000 to 2019 to identify English-language primary studies reporting PrEP use. Two reviewers independently screened citations, extracted data, and assessed the risk of bias with the modified Newcastle-Ottawa Scale. We estimated pooled proportions and crude/adjusted odds ratio. We identified 95 eligible studies including 95,854 US-based survey respondents. A few studies (6.3%) focused on persons who inject drugs. In 2015-2017, men who have sex with men (MSM) had highest proportion of individuals who used PrEP over their lifetime [13.9% (95% confidence interval: 8.8 to 21.1), k (number of surveys) = 49] followed by Hispanic/Latinos [11.5 (7.1 to 18.1), 12], transgender women [11.2 (5.8 to 20.6), 5], and blacks [9.9 (8.3 to 11.8), 18]. Odds of PrEP use increased by 34%/year [odds ratio = 1.34/year (95% confidence interval: 1.09 to 1.64)] and significantly increased over time among MSM [1.53/year (1.21-1.93)] and blacks [1.44 (1.13-1.83)]. People in the Southern United States [9.9 (4.7-19.7), 8] and youth [7.3 (4.7-11.2), 8] had lower rates and did not demonstrate growth [0.94 (0.29-3.18); 0.82 (0.43-1.55)]. Odds of reporting lifetime PrEP use was twice [2.07 (1.27-3.38)] as great among MSM than non-MSM. Proportions of PrEP use in published surveys have been growing, but remain low for people in the Southern United States and youth, and understudied in persons who inject drugs. Limitations include few studies in certain years, whereas strengths include a large number of respondents. Culturally tailored approaches targeting vulnerable populations are essential in increasing PrEP use to reduce disparities in HIV acquisition.

Racial/Ethnic Disparities in HIV Preexposure Prophylaxis Among Men Who Have Sex with Men - 23 Urban Areas, 2017.

In 2017, preliminary data show that gay, bisexual, and other men who have sex with men (MSM) accounted for 67% of new diagnoses of human immunodeficiency virus (HIV) infection, that MSM who inject drugs accounted for an additional 3%, and that African American/black (black) and Hispanic/Latino (Hispanic) MSM were disproportionately affected (1). During 2010-2015, racial/ethnic disparities in HIV incidence increased among MSM; in 2015, rates among black and Hispanic MSM were 10.5 and 4.9 times as high, respectively, as the rate among white MSM (compared with 9.2 and 3.8 times as high, respectively, in 2010) (2). Increased use of preexposure prophylaxis (PrEP), which reduces the risk for sexual acquisition of HIV infection by approximately 99% when taken daily as prescribed,* would help to reduce these disparities and support the Ending the HIV Epidemic: A Plan for America initiative† (3). Although PrEP use has increased among all MSM since 2014 (4), racial/ethnic disparities in PrEP use could increase existing disparities in HIV incidence among MSM (5). To understand racial/ethnic disparities in PrEP awareness, discussion with a health care provider, and use (steps in the HIV PrEP continuum of care) (6), CDC analyzed 2017 National HIV Behavioral Surveillance (NHBS) data. Black and Hispanic MSM were significantly less likely than were white MSM to be aware of PrEP, to have discussed PrEP with a health care provider, or to have used PrEP within the past year. Among those who had discussed PrEP with a health care provider within the past year, 68% of white MSM, 62% of Hispanic MSM, and 55% of black MSM, reported PrEP use. Prevention efforts need to increase PrEP use among all MSM and target eliminating racial/ethnic disparities in PrEP use.§.

Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya.

IntroductionThe World Health Organization, while recommending pre‐exposure prophylaxis (PrEP) for HIV‐negative pregnant and postpartum women in HIV high‐burden settings, advocates for continued safety evaluation of PrEP in this population.MethodsThe PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self‐reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother‐infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression.ResultsThe PrIYA evaluation identified 1530 postpartum mother‐infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP‐exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large‐scale programmatic implementation of PrEP among pregnant and postpartum populations.ConclusionsPregnancy outcomes and early infant growth did not differ by PrEP exposure.

Understanding the impact of a syndemic on the use of pre-exposure prophylaxis in a community-based sample of behaviorally PrEP-eligible BMSM in the United States

ABSTRACTHIV Pre-Exposure Prophylaxis (PrEP) has shown great promise in reducing HIV transmission among affected populations; however, PrEP uptake among Black men who have sex with men (BMSM) has stalled. This study compares BMSM using PrEP and BMSM at risk for HIV not using PrEP based on differences in behavior, psychosocial conditions and the presence of a syndemic (n = 1,411). BMSM reporting PrEP use were significantly more likely to report three of five HIV risk behaviors and three of four psychosocial conditions. Odds of reporting PrEP use increased as the number of psychosocial conditions increased such that BMSM with three psychosocial conditions (AOR = 5.65, 95% CI: 3.17, 10.08) and four conditions (AOR = 18.34, 95% CI: 5.01, 67.20) demonstrated significantly greater odds of PrEP use compared to BMSM reporting one or less conditions. While BMSM at greatest risk are using PrEP, strategies are still needed for men at varying risk levels.