Efficacy Of Pre-exposure Prophylaxis Research Articles

Two-dose emtricitabine/tenofovir alafenamide plus bictegravir prophylaxis protects macaques against SHIV infection.

ObjectivesCurrent prophylaxis options for people at risk for HIV infection include two US FDA-approved daily pre-exposure prophylaxis (PrEP) regimens and guidelines for a 2-1-1 event-driven course specifically for men who have sex with men. Despite this, PrEP use rates remain suboptimal, and additional PrEP options may help to improve uptake among diverse populations. Here, we evaluated protective efficacy of two-dose PrEP and two-dose postexposure prophylaxis (PEP) schedules with emtricitabine (FTC)/tenofovir alafenamide (TAF) with or without bictegravir (BIC) in an SHIV macaque model.MethodsMacaques received one oral dose of 200 mg emtricitabine, 25 mg tenofovir alafenamide and 25-100 mg of bictegravir to establish pharmacokinetic profiles of each drug either in the plasma or the peripheral blood mononuclear cells. Protective efficacy of multiple two-dose PrEP and PEP schedules with FTC/TAF with or without bictegravir was then assessed in two repeat low-dose rectal SHIV challenge studies.ResultsThe data revealed over 95% per-exposure risk reduction with FTC/TAF PrEP initiated 2 h before the exposure, but a loss of significant protection with treatment initiation postexposure. In contrast, FTC/TAF plus BIC offered complete protection as PrEP and greater than 80% per-exposure risk reduction with treatment initiation up to 24 h postexposure.ConclusionsTogether, these results demonstrate that two-dose schedules can protect macaques against SHIV acquisition and highlight the protective advantage of adding the integrase inhibitor bictegravir to the reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide as part of event-driven prophylaxis.

A review of reported cases of HIV pre-exposure prophylaxis failure with resultant breakthrough HIV infections.

Early randomized controlled trials (RCTs) have confirmed high efficacy of pre-exposure prophylaxis (PrEP) for preventing HIV infection in men who have sex with men (MSM) with high HIV exposure risk. Nevertheless, some PrEP failure cases have been reported despite adequate drug adherence. This review aims to summarize the common features of PrEP failure cases and discuss the implications of upscaling PrEP programmes. A search based on articles and clinical trials was conducted through Medline and OVID, with keywords for accessing publications reporting 'true' PrEP failure in the presence of documented adherence to daily regimen of co-formulated tenofovir disoproxil fumarate/emtricitabone. Ten cases of 'true' PrEP failure were identified, all of which were preceded by continued practice of condomless anal sex, despite documented adherence. Dried blood spot and/or hair analyses provided supporting evidence of adherence in eight cases. There was strong association of PrEP failure with recurrent or multiple sexually transmitted diseases and infection with resistant HIV viruses. Seroconversion was usually atypical or delayed because of significantly suppressed viral load, making diagnosis a clinical challenge. Although it is uncommon, 'true' PrEP failure can occur in a real-world situation, contrary to the outcome of early RCTs. Failure to identify HIV infection while on PrEP can potentially lead to the emergence of drug-resistant virus. To achieve effective HIV prevention, PrEP programmes should emphasize safer sexual practice in addition to drug adherence. Early identification of PrEP failure is crucial, which requires the development of highly sensitive assays and their clinical application.

Lamivudine/Tenofovir Disoproxil Fumarate is an Appropriate PrEP Regimen.

Oral pre-exposure prophylaxis (PrEP) containing tenofovir disoproxil fumarate (TDF) co-formulated with emtricitabine (FTC) or lamivudine (3TC) is recommended as an additional prevention option for persons at substantial risk of HIV infection by both the World Health Organization (WHO) and the US President's Emergency Plan for AIDS Relief (PEPFAR). The WHO and PEPFAR consider 3TC clinically interchangeable with FTC for PrEP given comparable pharmacologic equivalence, resistance and toxicity patterns, and indirect clinical trial evidence from TDF-containing studies. Globally, FTC/TDF has been widely used in clinical trials, open-label extension studies and demonstration projects. Thus, most PrEP efficacy and safety data are based on FTC/TDF use in heterosexual women and men, men who have sex with men, and people who inject drugs. However, generic 3TC/TDF is less expensive than FTC/TDF, is already available in supply chains for HIV drugs, and has 60-70% of the global adult market share, making it particularly appealing in settings with limited availability or affordability of FTC/TDF. Compelling indirect evidence suggests that scaling up use of 3TC/TDF is potentially cost saving for HIV programs in settings where restricting drug choice to FTC/TDF would delay PrEP implementation. Guideline committees and public health decision-makers in countries should encourage flexibility in PrEP drug selection, support off-label use of 3TC/TDF, and approve use of generic formulations to decrease the cost of PrEP medications and accelerate PrEP delivery through the public and private sectors.

Effect of HIV pre-exposure prophylaxis (PrEP) on detection of early infection and its impact on the appropriate post-PrEP deferral period.

HIV antivirals for pre-exposure prophylaxis (PrEP) are known to affect detection of early HIV infection through suppression of viral load and delayed seroconversion. To cover potential delay in HIV detection associated with PrEP use by blood donors in the context of international reductions in sexual activity-based deferral periods, we analysed the available data to determine the appropriate minimum post-PrEP deferral period for blood donation. Published cases of incident HIV infection when PrEP use was objectively demonstrable were identified, consisting principally of seroconverters from the Partners PrEP study (a clinical trial of PrEP efficacy). Data were reviewed to determine the impact of PrEP on the detection of HIV RNA, p24 Ag and seroconversion delay. Nucleic acid testing (NAT) detected early HIV infection in the presence of PrEP prior to or in concordance with serological testing in approximately 90% of cases. Undetectable HIV RNA would rebound to detectable levels within two months of PrEP cessation. PrEP delayed p24 antigen detection and antibody seroconversion by about 7days. Even when daily PrEP is continued, it is likely that the majority of early HIV infections are detectable by individual donation (ID)-NAT, with p24 Ag or antibody seroconversion occurring conservatively within four weeks of exposure. HIV RNA levels also rebound rapidly in the absence of PrEP. In Australia, a three-month deferral period for blood donation after the last dose of PrEP provides an appropriate safety margin to mitigate the residual risk of transfusion-transmitted HIV.

Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.

Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be "very" or "completely" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.

PrEP in India’s HIV Prevention Policy in the Era of Social Media and Sex Positivity

Introduction:The global revolution of online social media and connectivity had a tremendous effect on sexual behavior in both developed and developing countries. This global change is influencing the societal structure and existing social principles. Moreover, it has a significant impact on the epidemiology of different infectious diseases, especially HIV.Discussion:India is one of the most diverse democratic countries that has undergone a social-cultural transition in the last decade. However, having the second-highest HIV infection rate in the world, India does not have any other new prevention tools in their national HIV prevention strategy. Pre-Exposure Prophylaxis (PrEP), a boon of HIV prevention widely used in different countries, is still not implemented in India. The concept of “Digital India” by the Government of India is giving wide access of internet to the people of India. Furthermore, people are exposed to social media, and that is impacting their sex seeking behavior. Interestingly, recent legal changes in India promotes sex positivity. It also calls for introspection on existing HIV preventive strategies.Conclusions:Given the current scenario of PrEP and other existing preventive measurements of HIV, further research is needed to determine the acceptance and efficacy of PrEP and improve engagement in care for individuals in India. Various international studies recommend effective implication of PrEP to reduce the rate and economic burden of HIV infection.

HIV Antiretroviral Treatment and Pre-exposure Prophylaxis in Transgender Individuals.

HIV prevalence is elevated among transgender populations with an estimated 13.7% of transgender adults living with HIV in the USA. In addition, transgender people experience significant disparities in biomedical HIV prevention and treatment. The efficacy of topical microbicides for prevention of HIV acquisition have not been tested among transgender people and may be impacted by hormonal therapies and/or surgeries undertaken by some transgender people to align their anatomy with their gender identity. Low pre-exposure prophylaxis (PrEP) uptake and adherence as well as potential drug-hormone interactions impact the efficacy of PrEP among transgender women. Few transgender men have been engaged in the PrEP continuum, and they have been largely excluded from PrEP research until very recently. Prioritisation of hormone therapy over HIV treatment as well as concerns about drug-hormone interactions may impact transgender women's adherence to antiretroviral therapy. More research is needed to clarify the clinical significance of identified drug-hormone interactions and better inform interventions to improve HIV prevention and care for transgender people.

Pre-exposure prophylaxis HIV/AIDS mathematical model with non classical isolation

We propose a mathematical model to understand the transmission dynamics of HIV/AIDS in an environment. In addition to previous approaches, we incorporate two classes of isolated. By isolated we do not mean physical separation, but commitment to keep its status. We establish the well-posedness of our model and fully analyze the asymptotic behavior of the solutions which depends on the basic reproduction number $$R_{0}$$ . We then perform sensitive analysis to investigate the best strategy to keep the average number of secondary infection $$R_{0}$$ low. Our investigation reveals that when there is both high awareness and high efficacy of PrEP (pre-exposure prophylaxis) use, increasing the efficacy of PrEP use decreases $$R_{0}$$ the most. Otherwise, the best strategy is to isolated more susceptible to the class $$H_{1}$$ . Our model can be applied to any organizations/companies relying on physical labor forces (with some workers being infected by HIV/AIDS).

Male partners’ influence on women’s acceptance and use of PrEP products across two high HIV-burdened districts in South Africa

The demonstrated efficacy of pre-exposure prophylaxis (PrEP) has brought hope of controlling the epidemic among women with limited HIV preventation options. Several studies have demonstrated the importance of male partner involvement in female sexual and reproductive health but there is limited research on male involvement in the adoption of HIV prevention methods among women. Using a culture-centred approach, this article discusses perceptions of female-initiated HIV prevention methods among men and women. The data were collected using eight sex-specific focus group discussions with a sample of men and women aged between 18 and 49 years from selected urban and rural settings in two provinces of South Africa, KwaZulu-Natal and Mpumalanga. Thematic analysis was utilised to identify four key themes: increased infidelity in relationships and risky behaviour; association of PrEP with casual relationships; a partner’s right to know that women are reducing their risk of HIV infection; and that men need to engage in decision-making on HIV risk reduction. The article highlights the importance of partner engagement and knowledge sharing of female-initiated prevention methods as part of a combination HIV-prevention strategy, and the urgency of creating enabling environments to utilise female-initiated methods.

Cost utility analysis of HIV pre exposure prophylaxis among men who have sex with men in Israel

BackgroundBetween 2011 and 2015, Men who have sex with men (MSM) accounted for nearly half of new HIV cases among men in Israel. This study carries out a cost-utility analysis of PrEP (HIV Pre Exposure Prophylaxis), an antiretroviral medication that can protect against the acquisition of HIV infection, whose incidence rate in Israel is around 1.74 per 1000 MSM.MethodEpidemiological, demographic, health service utilisation and economic data were integrated into a spread-sheet model in order to calculate the cost per averted disability-adjusted life year (DALY) of the intervention from a societal perspective, in mid-2018 US$ using a 3% discount rate. Cost utility analyses were performed for both types of PrEP delivery (continuous regimen and on-demand), together with sensitivity analyses on numbers of condom users who take up PrEP (baseline 25%) and subsequently abandon condom use (baseline 75%), PrEP efficacy (baseline 86%), PrEP prices and monitoring costs.ResultsAround 21.3% of MSM are high risk (as defined by having unprotected anal intercourse). Offering PrEP to this group would have a ten year net cost of around 1563 million USD, preventing 493 persons from becoming HIV-positive, averting around 1616 DALYs at a cost per averted DALY of around 967,744 USD. This will render the intervention to be not cost-effective. PrEP drug prices would have to fall dramatically (by 90.7%) for the intervention to become cost-effective (i.e. having a cost per averted DALY less than thrice GNP per capita) in Israel. PrEP remains not cost-effective (at 475,673 USD per averted DALY) even if intervention costs were reduced by using an “on demand” instead of a daily schedule. Even if there were no changes in condom use, the resultant 411,694 USD cost-utility ratio is still not cost-effective.ConclusionsDespite PrEPs high effectiveness against HIV, PrEP was found not to be cost-effective in the Israeli context because of a combination of relatively low HIV incidence, high PrEP costs, with a likelyhood that some low-risk MSM (ie: who use condoms) may well begin taking PrEP and as a consequence many of these will abandon condom use. Therefore, ways of minimizing these last two phenomena need to be found.

Facing increased sexually transmitted infection incidence in HIV preexposure prophylaxis cohorts: what are the underlying determinants and what can be done?

The combined incidence of chlamydia, gonorrhoea and syphilis in MSM PrEP (preexposure prophylaxis) cohorts now frequently exceeds 100 per 100 person years. The efficacy of antiretroviral PrEP in reducing HIV transmission has led to efforts to find similar biomedical ways reduce sexually transmitted infection (STI) incidence. We review the recent evidence for these and other strategies. Doxycycline PrEP/postexposure prophylaxis has been shown to reduce the incidence of syphilis and chlamydia but not gonorrhoea. A meningococcal vaccine has been found to result in a lower incidence of gonorrhoea. Novel insights into the role of the pharynx in the transmission of gonorrhoea have led to clinical trials of oral antiseptics to reduce the spread of gonorrhoea. Intensified STI screening has been introduced in a number of clinics. Serious concerns have however been raised about the emergence of resistance to each of these strategies. This is particularly true for doxycycline PrEP which is not advocated by any guidelines we reviewed. Randomized controlled trials are urgently required to ascertain the benefits and risks of interventions to reduce STIs in MSM PrEP cohorts.

Translational Approach to Predicting the Efficacy of Maraviroc-Based Regimens as HIV Preexposure Prophylaxis.

Maraviroc-based regimens have been explored as preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV). In this study, we utilized mucosal tissue drug exposure data, combined with target concentrations generated in vitro, in a pharmacokinetic-pharmacodynamic analysis to predict the effects of drug combinations and adherence on PrEP efficacy. Mucosal tissue concentrations of maraviroc were measured in 24 healthy women. The 90% effective concentrations (EC90) of maraviroc (alone and combined with tenofovir and emtricitabine) for protection against HIV were identified in CD4+ T cells. Monte Carlo simulations were performed to identify dosing strategies to protect colorectal and female genital tract (FGT) tissues from HIV infection. Colorectal maraviroc concentrations were 350-fold higher than in the FGT. Under steady-state conditions, our model predicted that one 300-mg dose/week was sufficient to protect colorectal tissue from HIV in 99% of the population, while 300 mg daily would protect the FGT in only 63% of the population. FGT protection increased to >90% when maraviroc was used in combination with tenofovir (5 doses/week) or emtricitabine (3 doses/week). Poor adherence resulted in a drastic decrease in efficacy in the FGT but not colorectal tissue. However, greater forgiveness was seen when maraviroc was combined with tenofovir or emtricitabine, suggesting that maraviroc should not be used alone as PrEP.

A Review of Pre-Exposure Prophylaxis Adherence among Female Sex Workers.

Globally and in Africa specifically, female sex workers (FSWs) are at an extraordinarily high risk of contracting human immunodeficiency virus (HIV). Pre-exposure prophylaxis (PrEP) has emerged as an effective and ethical method with which to prevent HIV infection among FSWs. PrEP efficacy is, however, closely linked to adherence, and adherence to PrEP among FSWs is a complex and interrelated process that has been shown to be of importance to public health policies and HIV control and intervention programs. This comprehensive review categorizes barriers to and facilitators of adherence to HIV PrEP for FSWs, and describes five strategies for promoting PrEP adherence among FSWs. These strategies encompass 1) a long-term educational effort to decrease the stigma associated with sex work and PrEP use, 2) education on how PrEP works, 3) lifestyle modification, 4) research on next-generation PrEP products to address the inconvenience of taking daily pills, and 5) integration of PrEP into existing services, such as social services and routine primary care visits, to reduce the economic burden of seeking the medication. Our review is expected to be useful for the design of future PrEP intervention programs. Multidisciplinary intervention should be considered to promote PrEP adherence among FSWs in order to help control the HIV epidemic.

Sexual health needs of female sex workers in Côte d’Ivoire: a mixed-methods study to prepare the future implementation of pre-exposure prophylaxis (PrEP) for HIV prevention

ObjectiveTo describe sexual and reproductive health (SRH) needs of female sex workers (FSWs) to inform the future implementation of pre-exposure prophylaxis (PrEP) for HIV prevention in this population.Design and settingThe...

2560. Assessing Resident Perspectives on Prescribing Pre-Exposure Prophylaxis for HIV

BackgroundOver 15,000 people were living with HIV in Michigan in 2017. Kalamazoo County is one of the ten counties with the highest prevalence rate. Despite the efficacy of pre-exposure prophylaxis (PrEP) and updated guidelines from CDC/USPSTF with daily dosing of oral tenofovir/emtricitabine, 35% of patients encounter a physician who is unwilling to prescribe PrEP. One-third of primary care providers (PCP) are unaware of it. We investigated the perspectives of residents in several primary care-focused residency programs regarding PrEP and barriers to its prescription.MethodsWe surveyed 108 residents at Western Michigan University Homer Stryker M.D. School of Medicine from the departments of Internal Medicine, Medicine-Pediatrics, Pediatrics, Family Medicine, and OB/GYN. An anonymous electronic seven-question survey was sent, accompanied by a brief PrEP guideline.ResultsOf 108 residents surveyed, 53 responded (49%). The majority (45%) were in their intern year (Figure 1). Most respondents (67%) felt somewhat to very comfortable with providing counseling on safe sex practices and HIV prevention (Figure 2). Over 80% of respondents were aware of PrEP prior to reviewing the accompanying guideline. More than 70% of respondents would prescribe PrEP to patients in commercial sex work and serodiscordant couples, but only 30% were willing to prescribe PrEP to heterosexual men or women, and 8% were unwilling to prescribe PrEP at all (Figure 3). The main reason reported for not prescribing PrEP was inadequate knowledge about medication monitoring and follow-up (Figure 4). Only one respondent reported religious or moral beliefs affecting their prescribing habits. The vast majority (98%) of respondents would be more willing to prescribe PrEP with further education.ConclusionThe majority of residents were comfortable with sex education and counseling on HIV prevention, which could help identify at-risk patients. There was wide variation in willingness to prescribe PrEP among indications, but little variation in reasons why PrEP is not being prescribed. This suggests either limited knowledge about the indications or possibly subconscious bias. Our results are consistent with previous literature that additional medical education on PrEP is essential to its utilization by PCPs. Disclosures All authors: No reported disclosures.

Efficacy, Adherence and Side Effects of PrEP for HIV-1 Prevention

Each year, approximately two million new HIV infections are reported worldwide. About one decade ago, a company called Gilead Sciences Inc. discovered a new HIV prevention method named as pre-exposure prophylaxis (PrEP). When high adherence was kept among high-risk population, PrEP efficacy could reach as high as 99%. However, the adverse effects have been reported from time to time, including low efficacy in certain cases, adherence difficulties and medicinal side effects. In this review, we would summarize the progress of PrEP since its introduction in order to provide insights for HIV prevention.

Predicted Effectiveness of Daily and Nondaily Preexposure Prophylaxis for Men Who Have Sex With Men Based on Sex and Pill-taking Patterns From the Human Immuno Virus Prevention Trials Network 067/ADAPT Study.

The HIV Prevention Trials Network (HPTN) 067/Alternative Dosing to Augment PrEP Pill Taking (ADAPT) Study evaluated the feasibility of daily and nondaily human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) regimens among high-risk populations, including men who have sex with men (MSM) and transgender women, in Bangkok, Thailand and Harlem, New York. We used a mathematical model to predict the efficacy and effectiveness of different dosing regimens. An individual-based mathematical model was used to simulate annual HIV incidence among MSM cohorts. PrEP efficacy for covered sex acts, as defined in the HPTN 067/ADAPT protocol, was estimated using subgroup efficacy estimates from the preexposure prophylaxis initiative (iPrEx) trial. Effectiveness was estimated by comparison of the HIV incidence with and without PrEP use. We estimated that PrEP was highly protective (85%-96% efficacy across regimens and sites) for fully covered acts. PrEP was more protective for partially covered acts in Bangkok (71%-88% efficacy) than in Harlem (62%-81% efficacy). Our model projects 80%, 62%, and 68% effectiveness of daily, time-driven, and event-driven PrEP for MSM in Harlem compared with 90%, 85%, and 79% for MSM in Bangkok. Halving the efficacy for partially covered acts decreases effectiveness by 8-9 percentage points in Harlem and by 5-9 percentage points in Bangkok across regimens. Our analysis suggests that PrEP was more effective among MSM in Thailand than in the United States as a result of more fully covered sex acts and more pills taken around partially covered acts. Overall, nondaily PrEP was less effective than daily PrEP, especially in the United States where the sex act coverage associated with daily use was substantially higher.

Pre-Exposure Prophylaxis for HIV Prevention in Women: Current Status and Future Directions.

Pre-exposure prophylaxis (PrEP) is a promising intervention to prevent HIV acquisition, with benefits both to the individual and to population-level health. PrEP is an opportunity to complement ongoing public health efforts to eliminate HIV. For women, PrEP can also serve as a gateway to access sexual and reproductive health (SRH) services. Clinical efficacy of PrEP was initially reported in women using a 1% tenofovir vaginal gel in 2010, followed by an efficacy trial of oral PrEP using TDF/FTC in men who have sex with men (MSM). Since then, further trials have reported efficacy in oral PrEP containing tenofovir in women and heterosexual men, while the subsequent trials for women using tenofovir gel reported no efficacy, stemming from difficulties in achieving adequate adherence. In an effort to offer women additional choices to oral PrEP, alternative modalities are being tested in clinical research, including long-acting injectable formulations and intra-vaginal rings. In 2015, a meta-analysis of clinic trials and open-label extension studies led to the World Health Organization (WHO) strongly recommending the provision of oral PrEP containing tenofovir for any person at substantial risk of HIV infection, irrespective of gender or population group. Currently, PrEP services for women around the world, including those who are either pregnant or breastfeeding, remain limited. Outside sub-Saharan Africa, most PrEP programmes are focused on MSM. South Africa, Kenya, and the USA have the greatest utilization of oral PrEP by women. Yet, since 2012, of the estimated > 300,000 people globally who have initiated PrEP, a minority are women. In this narrative review, we examine the most recent literature on clinical and implementation PrEP research among women. We highlight the high burden of disease related to common sexually transmitted infections (STIs) in women, and the opportunity to integrate PrEP and other HIV prevention services, STI case management, and family planning services, as part of a more robust package of SRH services. Raising awareness on PrEP amongst women and their healthcare providers, minimizing gaps in access, and ensuring adherence and persistence of PrEP during periods of risk are critical issues if PrEP can have a meaningful impact on reducing HIV incidence in women globally.

Drug-drug interactions between feminizing hormone therapy and pre-exposure prophylaxis among transgender women: the iFACT study.

IntroductionConcerns over potential drug‐drug interactions (DDI) between feminizing hormone therapy (FHT) and pre‐exposure prophylaxis (PrEP) have hampered uptake and adherence of PrEP among transgender women (TGW). To determine DDI between FHT and PrEP, we measured the pharmacokinetic (PK) parameters of blood plasma estradiol (E2) and tenofovir (TFV) in Thai TGW.MethodsTwenty TGW who never underwent orchiectomy and had not received injectable FHT within six months were enrolled between January and March 2018. FHT (E2 valerate and cyproterone acetate) were prescribed to participants at baseline until week 5, and then from week 8 until the end of study. Daily PrEP (tenofovir disoproxil fumarate/emtricitabine) was initiated at week 3 and continued without interruption. Intensive E2 PK parameters and testosterone concentration at 24 hours (C24) were measured at weeks 3 (without PrEP) and 5 (with PrEP), and intensive TFV PK parameters were measured at weeks 5 (with FHT) and 8 (without FHT).ResultsMedian (interquartile range) age, body mass index, and creatinine clearance were 21.5 (21–26) years, 20.6 (19.0‐22.4) kg/m2, and 116 (101‐126.5) mL/min, respectively. The geometric mean (%CV) of area under curve from time zero to 24 hours (AUC0‐24), maximum concentration (Cmax), and C24 of E2 at weeks 3 and 5 were 775.13 (26.2) pg h/mL, 51.47 (26.9) pg/mL, and 15.15 (42.0) pg/mL; and 782.84 (39.6), 55.76 (32.9), and 14.32 (67.4), respectively. The geometric mean (%CV) of TFV AUC0‐24, Cmax, and C24 at weeks 5 and 8 were 2242.1 (26.5) ng h/mL, 353.9 (34.0) ng/mL, and 40.9 (31.4) ng/mL; and 2530.2 (31.3), 311.4 (30.0), and 49.8 (29.6), respectively. The geometric mean of TFV AUC0‐24 and C24 at week 5 were significantly less than that at week 8 by 12% (p = 0.03) and 18% (p < 0.001), respectively. There were no significant changes in E2 PK parameters and median C24 of bioavailable testosterone between week 3 and week 5.ConclusionsOur study demonstrated lower blood plasma TFV exposure in the presence of FHT, suggesting that FHT may potentially affect PrEP efficacy among TGW; but E2 exposure was not affected by PrEP. Further studies are warranted to determine whether these reductions in TFV are clinically significant.Clinical Trial Number: NCT03620734.

Utilization of an Animated Electronic Health Video to Increase Knowledge of Post- and Pre-Exposure Prophylaxis for HIV Among African American Women: Nationwide Cross-Sectional Survey.

BackgroundDespite renewed focus on biomedical prevention strategies since the publication of several clinical trials highlighting the efficacy of pre-exposure prophylaxis (PrEP), knowledge of postexposure prophylaxis (PEP) and PrEP continues to remain scarce among women, especially among African American women who are disproportionally affected by HIV. In an effort to address this barrier and encourage uptake of PEP and PrEP, an electronic health (eHealth) video was created using an entertainment-education format.ObjectiveThe study aimed to explore the feasibility, acceptability, and preference of an avatar-led, eHealth video, PEP and PrEP for Women, to increase awareness and knowledge of PEP and PrEP for HIV in a sample of African American women.MethodsA cross-sectional, Web-based study was conducted with 116 African American women aged 18 to 61 years to measure participants’ perceived acceptability of the video on a 5-point scale: poor, fair, good, very good, and excellent. Backward stepwise regression was used to the find the outcome variable of a higher rating of the PEP and PrEP for Women video. Thematic analysis was conducted to explore the reasons for recommending the video to others after watching the eHealth video.ResultsOverall, 89% of the participants rated the video as good or higher. A higher rating of the educational video was significantly predicted by: no current use of drugs/alcohol (beta=−.814; P=.004), not having unprotected sex in the last 3 months (beta=−.488; P=.03), higher income (beta=.149; P=.03), lower level of education (beta=−.267; P=.005), and lower exposure to sexual assault since the age of 18 years (beta=−.313; P=.004). After watching the eHealth video, reasons for recommending the video included the video being educational, entertaining, and suitable for women.ConclusionsUtilization of an avatar-led eHealth video fostered education about PEP and PrEP among African American women who have experienced insufficient outreach for biomedical HIV strategies. This approach can be leveraged to increase awareness and usage among African American women.