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PrEP use in a U.S. national sample of trans men and other trans masculine men who have sex with men: a longitudinal analysis
Abstract
INTRODUCTION
Efforts to improve PrEP uptake among gay men, transgender women, and Black cisgender women are evident across the US, responding to epidemiologic data showing a disproportionate HIV burden in these communities. However, transgender men and other trans masculine people (TMSM)—those assigned female at birth who identify otherwise and have sex with cisgender men—are often excluded from these statistics. This community has unique vulnerabilities and prevention needs. National HIV prevention and planning have yet to include transgender men as a group with increased vulnerability to HIV seroconversion. This study follows a cohort of TMSM to characterize PrEP use longitudinally.
METHODS
Using data from a prospective U.S. national cohort of TMSM not on PrEP, we analyzed annual PrEP uptake, discontinuation, and other HIV prevention measures over 24 months. We also used generalized estimating equations (GEE) modeling to assess demographic, healthcare access, gender-affirming, and behavioral factors associated with PrEP uptake over time.
RESULTS
Our cohort of 196 TMSM was demographic and regionally diverse. 29% of our sample reported uptake of PrEP in 24-months, with about one-third of users discontinuing within one-year. Health insurance, having had lower surgery, used PEP or recently having a STI were associated with increased odds of PrEP use.
CONCLUSION
We found low uptake of PrEP and high discontinuation rates in a U.S. national sample of TMSM over 24 months, despite significant need for HIV prevention. It is vital to increase efforts and investments to support this neglected community.
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Introduction:
Multiple studies have demonstrated elevated incidence and prevalence of HIV among transgender women; however, few studies have been conducted among transmasculine individuals. HIV prevalence among transgender men in the United States is estimated to be 0-4%; however, there have not been any US studies examining HIV prevalence that stratify by the gender of sexual partners. The aim of this research was to examine HIV prevalence and its association with socio-demographic and other factors, including the gender of sexual partners and receipt of gender-affirming care (hormones/surgery), among transmasculine individuals at the Callen-Lorde Community Health Center in New York City.
Methods:
The Transgender Data Project was an Institutional Review Board-approved retrospective chart review of all transgender and gender diverse clients at the clinic, ages 18+, between 1 January 2009 and 12 December 2010. Charts were reviewed manually. Data included birth sex, gender, race/ethnicity, education, employment, housing, insurance status, gender of sexual partners, HIV screening and status, and receipt of gender-affirming care. Bivariate and multivariable logistic regression models were used to assess the association between HIV status and other variables.
Results and discussion:
Five hundred and seventy-seven transmasculine individuals, mean age 32.1 years (18.3-70.5), were included in this analysis. A small majority were White (55% White, 13.9% Black and 11.7% Hispanic). The majority, 78.9%, had received hormones (testosterone) and 41.6% had received at least one gender-affirming surgery. The HIV screening rate was 43.4%. HIV prevalence was 2.8%, (95% CI: 1.13%, 5.68%) among those screened, notably higher than the US population prevalence. HIV prevalence was highest among transmasculine individuals who had sex exclusively with cisgender men (11.1%). In the multivariable model (age, education and gender of sexual partners), the adjusted odds ratio of HIV for those who had sex exclusively with cisgender male partners compared to no cisgender male partners was 10.58 (95% CI: 1.33, 84.17).
Conclusions:
Although HIV prevalence has been estimated to be low among transgender men, the analysis found heterogeneous results when stratified by gender of sexual partners. The results underscore the need to understand sexual risk among transmasculine individuals and to disaggregate HIV data for those having sex with cisgender men, thus also allowing for better inclusion in HIV prevention efforts.
The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.
Objective
To explore the association of clinical guideline-related variables, demographics and Medicaid expansion on pre-exposure prophylaxis (PrEP) uptake in one of the largest US sample of men who have sex with men(MSM) and transgender and gender non-binary (TGNB) people ever analysed.
Methods
We cross-sectionally analysed predictors of current PrEP use using demographic and HIV risk-related variables (level-1), as well as state-level variables (level-2) (ie, Medicaid expansion status). We further explored the role state of residence plays in PrEP uptake disparities across the USA.
Results
We found that the odds of PrEP use were significantly greater in older age, white, cisgender men. Moreover, individuals who reported recent post-exposure prophylaxis use, a recent sexually transmitted infection diagnosis and recent drug use were significantly more likely to report PrEP use. Finally, we found that the median odds of PrEP use between similar individuals from different states were 1.40 for the ones living in the Medicaid expansion states, compared with those not living in Medicaid expansion states. State of residence did not play a significant role in explaining PrEP disparities overall.
Conclusion
Our analysis showed that PrEP use is less common in communities standing to benefit the most from it—young MSM and TGNB of colour. However, individuals meeting federal guidelines for PrEP were significantly more likely to use PrEP. Though we found a positive association between living in Medicaid expansion states and PrEP use; that variable, as well as one’s state of residency, were not suitable to explain variations in PrEP use in the US.
Introduction
Transgender individuals are at risk for HIV. HIV risks are dynamic and there have been substantial changes in HIV prevention (e.g., pre-exposure prophylaxis [PrEP]). It is thus time to revisit HIV prevalence and burden among transgender individuals. The objective of this systematic review and meta-analysis was thus to examine worldwide prevalence and burden of HIV over the course of the epidemic among trans feminine and trans masculine individuals.
Methods
We conducted an updated systematic review by searching PsycINFO, PubMed, Web of Science, and Google Scholar, for studies of any research design published in in a peer-reviewed journal in any language that reported HIV prevalence among transgender individuals published between January 2000 and January 2019. Two independent reviewers extracted the data and assessed methodological quality. We then conducted a meta-analysis, using random-effects modelling, to ascertain standardized prevalence and the relative burden of HIV carried by transgender individuals by country and year of data collection, and then by geographic region. We additionally explored the impact of sampling methods and pre-exposure prophylaxis (PrEP).
Results
Based on 98 studies, overall standardized HIV prevalence over the course of the epidemic, based on weights from each country by year, was 19.9% (95% CI 14.7% - 25.1%) for trans feminine individuals (n = 48,604) and 2.56% (95% CI 0.0% - 5.9%) for trans masculine individuals (n = 6460). Overall OR for HIV infection, compared with individuals over age 15, was 66.0 (95% CI 51.4–84.8) for trans feminine individuals and 6.8 (95% CI 3.6–13.1) for trans masculine individuals. Prevalence varied by geographic region (13.5% - 29.9%) and sampling method (5.4% - 37.8%). Lastly, PrEP effects on prevalence could not be established.
Conclusion
Trans feminine and trans masculine individuals are disproportionately burdened by HIV. Their unique prevention and care needs should be comprehensively addressed. Future research should further investigate the impact of sampling methods on HIV prevalence, and monitor the potential impact of PrEP.
Background:
TRIUMPH (Trans Research-Informed communities United in Mobilization for the Prevention of HIV) was a community-led, transgender-specific pre-exposure prophylaxis (PrEP) demonstration project at 2 community-based clinical sites in California. TRIUMPH used peer health education, community mobilization, and clinical integration of PrEP with hormone therapy to promote PrEP knowledge and acceptability. The goal of this study was to evaluate PrEP uptake, retention, and adherence among TRIUMPH participants and examine site-based differences.
Methods:
Eligible participants were adult transgender and gender diverse people interested in PrEP. Participants were seen at baseline and at 1, 3, 6, 9, and 12 months for PrEP provision, clinical visits, and HIV testing. PrEP uptake was defined as dispensation of PrEP, PrEP retention was defined as proportion of expected visits completed among those who initiated PrEP, and PrEP adherence was assessed by measuring tenofovir diphosphate concentrations in dried blood spots. Logistic regression models quantified the association of variables with PrEP outcomes.
Results:
TRIUMPH enrolled 185 participants; the median age was 28 years (interquartile range: 23-35), 7% was Black, and 58% was Latinx. PrEP uptake was as follows: 78% in Oakland and 98% in Sacramento; 91% among trans women, 96% among trans men, and 70% among nonbinary participants. Almost half (47%) rarely/never believed about HIV, and 42% reported condomless sex act in the past 3 months. Participants who reported higher numbers of sex partners were more likely to be retained and adherent; other predictors of adherence included not having a primary partner and not experiencing violence in the past 3 months.
Conclusions:
This community-led, trans-specific PrEP demonstration project documents high levels of PrEP initiation in a young transgender and gender diverse cohort at risk of HIV acquisition.
Introduction:
Trans masculine people who have sex with cisgender ("cis") men ("trans MSM") may be at-risk for HIV infection when they have cis MSM partners or share needles for hormone or recreational drug injection. Limited data are available characterizing indications and uptake of pre-exposure prophylaxis (PrEP) in trans MSM. The aim of this study was to assess PrEP indication and uptake as a means of primary HIV prevention for adult trans MSM in the U.S.
Methods:
Between November and December 2017, a national convenience sample of trans MSM in the U.S. (n = 857) was recruited using participatory methodologies and completed an online survey of demographics, HIV risk, PrEP, behavioural and psychosocial factors. Self-reported receptive anal sex or frontal/vaginal sex (with or without a condom) with a cis male sex partner in past six months was an eligibility criterion. A multivariable logistic regression procedure was used to model PrEP indications (yes/no) per an interpretation of U.S. Centers of Disease Control and Prevention recommendations among those without HIV (n = 843).
Results:
The diverse sample was 4.9% Black; 22.1% Latinx ethnicity; 28.4% non-binary gender identity; 32.6% gay-identified; 82.7% on testosterone. Overall, 84.1% had heard of PrEP. Of these, 33.3% reported lifetime PrEP use (21.8% current and 11.5% past). Based on HIV behavioural risk profiles in the last six months, 55.2% of respondents had indications for PrEP. In a multivariable model, factors associated with PrEP indication included where met sex partners, not having sex exclusively with cismen, higher perceived HIV risk, greater number of partners and high cis male partner stigma (all p < 0.05).
Discussion:
The majority of trans MSM in this sample had a PrEP indication. Stigma was associated with risk for HIV acquisition and represents a critical target for HIV biobehavioural prevention interventions for trans MSM, who appear to be underutilizing PrEP.
Conclusions:
Results from this study support the full inclusion of trans MSM in HIV biobehavioural prevention efforts. Public health interventions and programmes are needed to reach trans MSM that attend to general MSM risk factors as well as to vulnerabilities specific to trans MSM, including the context of stigma from cis male sexual partners.
Preexposure prophylaxis (PrEP) with a daily, oral pill containing antiretroviral drugs is highly effective in preventing acquisition of human immunodeficiency virus (HIV) infection (1-4). The combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is the only medication approved by the Food and Drug Administration (FDA) for PrEP. PrEP is indicated for men and women with sexual or injection drug use behaviors that increase their risk for acquiring HIV (5). CDC analyzed 2014-2016 data from the IQVIA Real World Data - Longitudinal Prescriptions (IQVIA database) to estimate the number of persons prescribed PrEP (users) in the United States and to describe their demographic characteristics, including sex and race/ethnicity. From 2014 to 2016, the annual number of PrEP users aged ≥16 years increased by 470%, from 13,748 to 78,360. In 2016, among 32,853 (41.9%) PrEP users for whom race/ethnicity data were available, 68.7% were white, 11.2% were African American or black (black), 13.1% were Hispanic, and 4.5% were Asian. Approximately 7% of the estimated 1.1 million persons who had indications for PrEP were prescribed PrEP in 2016, including 2.1% of women with PrEP indications (6). Although black men and women accounted for approximately 40% of persons with PrEP indications (6), this study found that nearly six times as many white men and women were prescribed PrEP as were black men and women. The findings of this study highlight gaps in effective PrEP implementation efforts in the United States.
Purpose:
The number of individuals who have started a regimen for HIV pre-exposure prophylaxis (PrEP) in the United States is not well characterized but has been on the rise since 2012. This analysis assesses the distribution of PrEP use nationally and among subgroups.
Methods:
A validated algorithm quantifying tenofovir disoproxil fumarate/emtricitabine for PrEP in the United States was applied to a national prescription database to determine the quarterly prevalence of PrEP use. HIV diagnoses from 2016 were used as an epidemiological proxy for PrEP need. The PrEP-to-need ratio (PnR) was defined as the number of PrEP users divided by new HIV diagnoses.
Results:
A total of 70,395 individuals used PrEP in the fourth quarter of 2017: 67,166 males and 3229 females. Nationally, prevalence of PrEP use was 26/100,000 (range across states per 100,000 [RAS/100k]: 4-73) and the PnR was 1.8 (RAS: 0.5-6.6). Prevalence of PrEP use among males and females, respectively, was 50/100,000 and 2/100,000 (RAS/100k: 7-143 and 0.3-7) and PnR was 2.1 and 0.4 (RAS: 0.6-7.1 and 0.1-4.0). Prevalence of PrEP use was lowest among individuals aged less than or equal to 24 and more than or equal to 55 years (15/100,000 and 6/100,000, RAS/100k: 1-45 and 0.4-14), with PnR 0.9 and 1.5 (RAS: 0.2-5.6 and 0.3-7.0). The Northeast had the highest PnR (3.3); the South had the lowest (1.0). States with Medicaid expansion had more than double the PnR than states without expansion.
Conclusions:
Available data suggest that females, individuals aged less than or equal to 24 years and residents of the South had lower levels of PrEP use relative to epidemic need. These results are ecological, and misclassification may attenuate results. PnR is useful for future assessments of HIV prevention strategy uptake.
Purpose:
HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission. Finding a PrEP provider, however, can be a barrier to accessing care. This study explores the distribution of publicly listed PrEP-providing clinics in the United States.
Methods:
Data regarding 2094 PrEP-providing clinics come from PrEP Locator, a national database of PrEP-providing clinics. We compared the distribution of these PrEP clinics to the distribution of new HIV diagnoses within various geographical areas and by key populations.
Results:
Most (43/50) states had less than one PrEP-providing clinic per 100,000 population. Among states, the median was two clinics per 1000 PrEP-eligible men who have sex with men. Differences between disease burden and service provision were seen for counties with higher proportions of their residents living in poverty, lacking health insurance, identifying as African American, or identifying as Hispanic/Latino. The Southern region accounted for over half of all new HIV diagnoses but only one-quarter of PrEP-providing clinics.
Conclusions:
The current number of PrEP-providing clinics is not sufficient to meet needs. In addition, PrEP-providing clinics are unevenly distributed compared to disease burden, with poor coverage in the Southern divisions and areas with higher poverty, uninsured, and larger minority populations. PrEP services should be expanded and targeted to address disparities.
We surveyed 122 trans men using a hybrid sampling method that included randomly selected physical and online venues and peer referral to measure HIV prevalence and risk behaviors. HIV prevalence was 0% (one-sided 97.5% confidence interval 0–3.3%). Of 366 partnerships described, 44.8% were with cisgender women, 23.8% with cisgender men, 20.8% with trans men, and 10.7% with trans women. Condomless receptive anal and front hole/vaginal sex averaged one to three episodes per six months. HIV prevalence in trans men is likely closer to heterosexual cisgender men and women in San Francisco than trans women or MSM. Prevention prioritizing trans women and MSM, coupled with individualized and relevant sexual health education for trans men with partners from these populations, may best address the HIV prevention needs of trans men. Systematic collection of transgender status in Census and health data is needed to understand other health disparities among trans men.
Background:
Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.
Methods:
We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.
Results:
Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03).
Conclusions:
The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.).
Background:
In 2014, approximately 40,000 persons in the United States received a diagnosis of human immunodeficiency virus (HIV) infection. Preexposure prophylaxis (PrEP) with daily oral antiretroviral medication is a new, highly effective intervention that could reduce the number of new HIV infections.
Methods:
CDC analyzed nationally representative data to estimate the percentages and numbers of persons in the United States, by transmission risk group, with indications for PrEP consistent with the 2014 U.S. Public Health Service's PrEP clinical practice guideline.
Results:
Approximately 24.7% of sexually active adult men who have sex with men (MSM) (492,000 [95% confidence interval {CI} = 212,000-772,000]), 18.5% of persons who inject drugs (115,000 [CI = 45,000-185,000]), and 0.4% of heterosexually active adults (624,000 [CI = 404,000-846,000]), had substantial risks for acquiring HIV consistent with PrEP indications.
Conclusions:
Based on current guidelines, many MSM, persons who inject drugs, and heterosexually active adults have indications for PrEP. A higher percentage of MSM and persons who inject drugs have indications for PrEP than heterosexually active adults, consistent with distribution of new HIV diagnoses across these populations.
Implications for public health practice:
Clinical organizations, health departments, and community-based organizations should raise awareness of PrEP among persons with substantial risk for acquiring HIV infection and their health care providers. These data can be used to inform scale-up and evaluation of PrEP coverage. Increasing delivery of PrEP and other highly effective HIV prevention services could lower the number of new HIV infections occurring in the United States each year.
Background:
Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir-emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect.
Methods:
PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986).
Findings:
We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64-96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3-11·3). 13 men (90% CI 9-23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients.
Interpretation:
In this high incidence population, daily tenofovir-emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection.
Funding:
MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.
Referrals for and initiation of preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection increased
dramatically in a large clinical practice setting since 2012. Despite high rates of sexually transmitted infections among
PrEP users and reported decreases in condom use in a subset, there were no new HIV infections in this population.
Recent reports have addressed the sexual health of female-to-male transgender or transsexual people who are gay, bisexual, and/or have sex with men (trans GB-MSM) using urban convenience samples. The Trans PULSE Project conducted a multimode, respondent-driven sampling survey in Ontario, Canada, in 2009-2010. Weighted estimates were calculated for trans GB-MSM (n = 173) for sexual orientation, behavior, partners, and HIV-related risk, as well as for psychosocial stressors and sexual satisfaction. An estimated 63.3% (95% CI [50.4, 73.5]) of trans men were GB-MSM (173/227). Results indicate great diversity in sexual behavior and experiences. Implications for sexual health promotion, counseling, and medical care are addressed.
A tremendous growth in the use of multi-item scales in marketing research has occurred over the past two decades. Concurrently, there is increasing concern about the quality of these measures. Although the majority of marketing-related articles now discuss the reliability of the scales administered, few address the issue of scale validity. One aspect of scale validity, which should be of particular concern to marketing researchers, is the potential threat of contamination due to social-desirability response bias. However, a careful review of nearly 20 years of published research suggests that social-desirability bias has been consistently neglected in scale construction, evaluation, and implementation. The purpose of this article is to discuss the nature of such a bias, methods for identifying, testing for and/or preventing it, and how these methods can and should be implemented in consumer-related research. ©: 2000 John Wiley & Sons, Inc.
Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.
We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections.
The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).
Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).
Introduction:
PrEP use cotinues lag estimated need among gay and bisexual men in the U.S. Studies report that challenges paying for PrEP may undermine continued use. Our study aimed to measure these challenges over time.
Methods:
Data were taken from a U.S. national cohort study of cisgender gay and bisexual men and transgender individuals aged 16 to 49. We analyzed data from PrEP-using participants between 2019-2021 and observed cost- and insurance-related challenges participants experienced while on PrEP across timepoints. We report McNemar and Cochrane's Q test statistics to compare differences between groups by year(s).
Results:
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 timepoints for clinical appointments, lab work and prescriptions. Those experiencing insurance and copay approval issues did not change significantly. Though 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 to current PrEP users.
Discussion:
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.
Background:
There are few data available regarding the use of on-demand pre-exposure prophylaxis (PrEP) for HIV prevention. We aimed to assess PrEP effectiveness, adherence, and safety in adults using daily or on-demand PrEP.
Methods:
We conducted a prospective observational cohort study (ANRS PREVENIR) at 26 sites in the Paris region, France. We enrolled HIV-negative adults (aged ≥18 years) at high risk of HIV infection who were starting or continuing PrEP. PrEP was prescribed as a fixed-dose combination of tenofovir disoproxil and emtricitabine (245 mg and 200 mg, respectively, per pill). PrEP could be prescribed as a daily regimen with one pill per day or, in men who have sex with men (MSM) or in transgender women who have sex with men, as an on-demand regimen following the IPERGAY dosing recommendation. At enrolment and every 3 months thereafter, participants were tested for HIV and provided information regarding the PrEP dosing regimen used. Adherence to PrEP was assessed by self-report and by tenofovir diphosphate concentrations in dried blood spots. The primary outcome of HIV-1 incidence was assessed using Poisson regression among participants who started PrEP. This study is registered with ClinicalTrials.gov, NCT03113123, and EudraCT, 2016A0157744.
Findings:
Between May 3, 2017, and May 2, 2019, 3082 people were assessed for eligibility and 3065 participants were enrolled. 3056 (99·7%) of 3065 participants reported using PrEP and were included in the analyses. The median age was 36 years (IQR 29-43), 1344 (44·0%) of 3056 participants were PrEP-naive, and 3016 (98·7%) were MSM. At enrolment, 1540 (50·5%) of 3049 participants opted for daily PrEP dosing and 1509 (49·5%) opted for on-demand PrEP dosing; these proportions remained stable during follow-up. Median follow-up was 22·1 months (IQR 15·9-29·7) and incidence of study discontinuation was 17·6 participants (95% CI 16·5-18·7) per 100 person-years. At the data cutoff on Sept 30, 2020, there had been six HIV-1 seroconversions (three participants using daily PrEP and three using on-demand PrEP; all were MSM) over 5623 person-years. Overall HIV-1 incidence was 1·1 cases (95% CI 0·4-2·3) per 1000 person-years, and did not differ between participants using daily PrEP and those using on-demand PrEP (incidence rate ratio 1·00, 95% CI 0·13-7·49; p=0·99). Four participants (two using daily PrEP and two using on-demand PrEP) discontinued PrEP due to treatment-related adverse events (nausea [n=2], vomiting and diarrhoea [n=1], and lumbar pain [n=1]).
Interpretation:
In this study, which enrolled mainly MSM, HIV-1 incidence on PrEP was low and did not differ between participants using daily PrEP and those using on-demand PrEP. On-demand PrEP therefore represents a valid alternative to daily PrEP for MSM, providing greater choice in HIV prevention.
Funding:
ANRS/Maladies Infectieuses Emergentes, Gilead Sciences, SIDACTION, and Région Ile de France.
Translation:
For the French translation of the abstract see Supplementary Materials section.
HIV-outcome inequities remain prevalent in the U.S. Medical providers (MPs) are gatekeepers of PrEP, and understanding the dynamics of PrEP assessments is of major interest for public health. We analyzed data from Together 5000, an internet-based U.S. national cohort of sexual and gender minority (SGM) individuals aged 16-49 years and at risk for HIV. Among those eligible for PrEP uptake (n = 6264), we modeled predictors of discussing PrEP with an MP. A third (31%) of participants had spoken to a MP about PrEP. Among those who spoke to a MP, 45% suggested they would initiate PrEP; this outcome was more common among participants older than 24. With a persistent stagnant uptake nationwide, new opportunities to influence PrEP uptake must be explored. An attractive less targeted space is the medical office, specifically ways to support an initial and continued discussion about PrEP between MPs and their patients.
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.
Background
Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention.
Methods
This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02842086, and is no longer recruiting.
Findings
Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19–1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06–0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19–0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints.
Interpretation
Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
Funding
Gilead Sciences.
There is a growing interest in HIV infection and sexually transmitted infection (STI) disease burden and risk among transgender people globally; however, the majority of work has been conducted with male-to-female transgender populations. This research synthesis comprehensively reviews HIV and STI research in female-to-male (FTM) transgender adults. A paucity of research exists about HIV and STIs in FTMs. Only 25 peer-reviewed papers (18 quantitative, 7 qualitative) and 11 'grey literature' reports were identified, most in the US or Canada, that include data identifying HIV and STI risks in FTMs (five with fully laboratory-confirmed HIV and/or STIs, and five with partial laboratory confirmation). Little is known about the sexual and drug use risk behaviours contributing to HIV and STIs in FTMs. Future directions are suggested, including the need for routine surveillance and monitoring of HIV and STIs globally by transgender identity, more standardised sexual risk assessment measures, targeted data collection in lower- and middle-income countries, and explicit consideration of the rationale for inclusion/exclusion of FTMs in category-based prevention approaches with MSM and transgender people. Implications for research, policy, programming, and interventions are discussed, including the need to address diverse sexual identities, attractions, and behaviours and engage local FTM communities.
Importance
Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).Objective
To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.Design, Setting, and Participants
Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.Interventions
A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.Main Outcomes and Measures
Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.Results
Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion.Conclusions and Relevance
The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.
Persistence with human immunodeficiency virus pre-exposure prophylaxis in the United States, 2012–2017
- Huang
Preexposure Prophylaxis for the Prevention of HIV Infection in the United States -2021 Update Clinical Practice Guideline 2021
Centers for Disease Control and Prevention: US Public Health Service.
Preexposure Prophylaxis for the Prevention of HIV Infection in the
United States -2021 Update Clinical Practice Guideline 2021. Available at: https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed December 19, 2023.
Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2017 Update: A Clinical Practice Guideline
- Cdc
- Us
CDC. US Public Health Service: Preexposure Prophylaxis for the
Prevention of HIV Infection in the United States-2017 Update: A
Clinical Practice Guideline. https://www.cdc.gov/hiv/pdf/risk/prep/cdchiv-prep-guidelines-2017.pdf: CDC; 2018.
A National Action Plan for Universal Access to HIV Pre-exposure Prophylaxis (PrEP) in the United States. The PrEP4All Collaboration
- A Lord
- D Barr
- J Krellenstein
Lord A, Barr D, Krellenstein J, et al. A National Action Plan for
Universal Access to HIV Pre-exposure Prophylaxis (PrEP) in the United
States. The PrEP4All Collaboration; 2018. Available at: https://www.
prep4all.org/. Accessed December 19, 2023.
Persistence with human immunodeficiency virus pre-exposure prophylaxis in the United States
- Y-La Huang
- G Tao
- D K Smith
Huang Y-LA, Tao G, Smith DK, et al. Persistence with human
immunodeficiency virus pre-exposure prophylaxis in the United States,
2012-2017. Clin Infect Dis. 2021;72:379-385.